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Press review
Journal of Visceral Surgery (2017) 154, 287—294
Available online at
ScienceDirect www.sciencedirect.com
Press review C. Mariette a,∗, S. Benoist b, L. Brunaud c a
Service de chirurgie digestive et générale, hôpital C.-Huriez, CHRU, place de Verdun, 59037 Lille cedex, France b Service de chirurgie digestive, hôpital du Kremlin-Bicêtre, 78, rue du Général-Leclerc, 94275 Le Kremlin-Bicêtre, France c Service de chirurgie digestive, hôpital Brabois, CHRU de Nancy, rue du Morvan, 54500 Vandoeuvre-les-Nancy, France Available online 1 August 2017
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Intérêt d’une sigmoïdectomie élective en cas de douleur chronique ou de crises rapprochées après une première poussée de diverticulite non compliquée : résultats d’un essai contrôlé hollandais multicentrique van de Wall BJ, Stam MA, Draaisma WA, et al. Surgery versus conservative management for recurrent and ongoing left-sided diverticulitis (DIRECT trial): an open-label, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol 2017;2:13—22. http://dx.doi.org/10.1016/S2468-1253(16)30109-1
Background Patients with recurrent or persisting complaints after an episode of left-sided diverticulitis are managed with either conservative measures or elective sigmoidectomy. To date, there are no data from randomized trials. We aimed to establish which treatment leads to a better quality of life for patients with diverticulitis. Methods We did an open-label, multicenter, randomized controlled trial (DIRECT trial) in 24 teaching and two academic hospitals in the Netherlands. Patients aged 18—75 years presenting with either recurrent (three or more presentations with clinical signs of acute diverticulitis within 2 years) or persistent abdominal complaints (ongoing lower left abdominal pain or persistent change in bowel habits for ≥ 3 months) after an episode of left-sided diverticulitis, confirmed by CT, ultrasound, or endoscopy, were
∗
Corresponding author. E-mail address: [email protected] (C. Mariette).
1878-7886/$ — see front matter http://dx.doi.org/10.1016/j.jviscsurg.2017.06.007
included. Patients were excluded if they had previous elective or emergency surgery for acute sigmoid diverticulitis, an absolute operation indication, suspicion of a colorectal malignancy, with a preoperative or postoperative risk greater than III (on the American Society of Anesthesiologists classification), or were unable to complete questionnaire or follow-up. Patients were randomly assigned (3:3) to receive conservative management or elective (laparoscopic) sigmoidectomy using a digital randomization system, stratified by type of disease and center, with a block size of six. Patients, physicians, and researchers were not masked to treatment allocation. Our primary endpoint was healthrelated quality of life, measured by the Gastrointestinal Quality of Life Index (GIQLI) at 6 months after inclusion or surgery, depending on randomization group. This trial is registered with trialregister.nl, number NTR1478, and is closed for inclusion. Findings Between July 1, 2010, and April 1, 2014, we randomly assigned 109 patients to receive surgical treatment (resection; n = 53) or conservative management (n = 56), after which the Data Safety and Monitoring Board prematurely terminated the trial because of increasing difficulties in recruitment. In total, 47 (89%) of 53 patients received surgical treatment and 43 (77%) of 56 patients received conservative management. The GIQLI score at 6 months’ follow-up was significantly higher in patients randomly assigned to receive surgical treatment (mean 114.4 [SD 22.3]) than conservative management (100.4 [22.7]; mean difference 14.2, 95% CI: 7.2—21.1, P < 0.0001). In total, 43 (38%) of 109 patients had a severe adverse event in the first 6 months after treatment (18 [34%] of 53 patients in the surgical treatment group vs. 23 [40%] of 57 patients
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in the conservative treatment group). Seven (15%) patients who received surgical treatment developed anastomotic leakage. Of the 56 patients assigned to be treated conservatively, 13 (23%) ultimately underwent elective resection due to ongoing abdominal complaints, with no anastomotic leakage. We recorded no patient deaths. Interpretation Elective sigmoidectomy, despite its inherent risk of complications, results in better quality of life than conservative management in patients with recurrent and persisting abdominal complaints after an episode of diverticulitis. Comments 1. This trial was terminated early because of insufficient accrual and included only 109 of the 214 initially planned patients. However, with clinically pertinent and statistical significance, this trial favors prophylactic surgery for diverticular disease in these indications. 2. If only by the existence of the trial, it is probable that the surgical group benefited from a placebo effect, all the more so since no real treatment was proposed in the control arm. 3. The six-month delay to evaluate the quality of life seems rather short; it would have been of interest to know if this difference persisted in the longer term. 4. The permanent stoma rate, often given as an argument against prophylactic surgery, was low, less than 2%. On the other hand, the temporary stoma rate was 19%, particularly high for left colectomy with intra-peritoneal anastomoses. 5. It would now be interesting to run a new randomized trial assessing the value of prophylactic surgery in patients having sustained a first flare of diverticulitis with abscess or micro-perforation treated medically with success. Danielsen AK, Park J, Jansen JE, et al. Early closure of a temporary ileostomy in patients with rectal cancer: a multicenter randomized controlled trial. Ann Surg 2017;265:284—290. http://dx.doi.org/10.1097/SLA.0000000000001829
Objective The objective was to study morbidity and mortality associated with early closure (8—13 days) of a temporary stoma compared with standard procedure (closure after > 12 weeks) after rectal resection for cancer. Background A temporary ileostomy may reduce the risk of pelvic sepsis after anastomotic dehiscence. However, the temporary ileostomy is afflicted with complications and requires a second surgical procedure (closure) with its own complications. Early closure of the temporary ileostomy could reduce complications for rectal cancer patients. Methods Early closure (8—13 days after stoma creation) of a temporary ileostomy was compared with late closure (> 12 weeks) in a multicenter randomized controlled trial, EASY (www.clinicaltrials.gov, NCT01287637) including patients undergoing rectal resection for cancer. Patients with a temporary ileostomy without signs of postoperative complications were randomized to closure at 8 to 13 days or late closure (> 12 weeks after index surgery). Clinical data were collected up to 12 months. Complications were registered according to the Clavien-Dindo Classification of Surgical Complications, and Comprehensive Complication Index was calculated. Results
The trial included 127 patients in eight Danish and Swedish surgical departments, and 112 patients were available for analysis. The mean number of complications after index surgery up to 12 months follow-up was significantly lower in the intervention group (1.2) compared with the control group (2.9), P < 0.0001. Conclusions It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or radiological signs of anastomotic leakage. Comments 1. The conclusions of this trial must be interpreted with caution because the methodology is, for the least, surprising. First of all, the calculation of the number of patients necessary was based on the hypothesis that early closure (vs. late closure) would decrease the complication rate by 62%, whereas the only available controlled trial in the literature, more powerful, found that early closure did not lead to less overall morbidity [1]. Moreover, the analysis was not performed with intention to treat as 15 patients, that is, 11% of the initial sample, were withdrawn from analysis after randomization for unclear reasons. Last, we can consider that the trial was artificially positive by protocol violation. Effectively, in the group undergoing late closure, ileostomy should have been closed within 12 weeks but in fact, the median delay for closure was 18.5 weeks. Maintaining an ileostomy longer than planned could have contributed to the increased stoma-related complication rate. 2. The population in this study was highly selected: only 30% of potentially eligible patients were included. The main reason seems to be medical, but no clear explanation was given. This suggests that most patients were in poor physical condition eight days after proctectomy, and were not inclined, even in the absence of fistula, to undergo a second intervention so quickly. 3. If a third trial on the topic were to surface, a main end point of quality of life might be much more pertinent. Reference [1] Br J Surg 2008;95:693—698.
Roulin D, Saadi A, Di Mare L, et al. Early versus delayed cholecystectomy for acute cholecystitis, are the 72 hours still the rule? A randomized trial. Ann Surg 2016;264:717—722. http://dx.doi.org/10.1097/SLA.0000000000001886
Objective The aim of this study was to compare clinical outcomes of early versus delayed laparoscopic cholecystectomy (LC) in acute cholecystitis with more than 72 hours of symptoms. Background LC is the treatment of acute cholecystitis, with consensus recommendation that patients should be operated within 72 hours of evolution. Data however remain weak with no prospective study focusing on patients beyond 72 hours of symptoms. Methods Patients with acute cholecystitis and more than 72 hours of symptoms were randomly assigned to early LC (ELC) or delayed LC (DLC). ELC was performed following hospital admission. DLC was planned at least 6 weeks after initial antibiotic treatment. Primary outcome was overall morbidity following initial diagnosis. Secondary outcomes were
Press review total length of stay, duration of antibiotic therapy, hospital costs, and surgical outcome. Results Eighty-six patients were randomized (42 in ELC and 44 in DLC group). Overall, morbidity was lower in ELC [6 (14%) vs. 17 (39%) patients, P = 0.015]. Median total length of stay (4 vs. 7 days, P < 0.001) and duration of antibiotic therapy (2 vs. 10 days, P < 0.001) were shorter in the ELC group. Total hospital costs were lower in ELC (9349&OV0556; vs. 12,361 &OV0556;, P = 0.018). Operative time and postoperative complications were similar (91 vs. 88 min; P = 0.910) and (15% vs. 17%; P = 1.000), respectively. Conclusions ELC for acute cholecystitis even beyond 72 hours of symptoms is safe and associated with less overall morbidity, shorter total hospital stay, and duration of antibiotic therapy, as well as reduced cost compared with delayed cholecystectomy (NCT01548339). Comments 1. Initially the authors had planned a non-inferiority study but when the intermediary analysis showed that early cholecystectomy was so much better, they decided to transform the methodology to a superiority trial. 2. The conversion rate in the early cholecystectomy group was particularly low, compared to the 10—15% rates usually reported for acute cholecystitis [1—3], and therefore it is difficult to understand how all the included patients had cholecystitis of 72 h duration. As the inclusion criteria were based on patient history, it is possible that these patients had pain due only to biliary colic initially and that cholecystitis set in later. This inclusion bias might have considerably favored the outcome in the group undergoing early cholecystectomy. 3. Because of the monocenter character of this study, the reproducibility of results remains to be shown. References [1] Br J Surg 2015;102:1302—1313. [2] Ann Surg 2011;254:964—970. [3] JAMA Surg 2015;150:129—136.
Jupiter DC, Fang X, Adhikari D, et al. Safety of continued clopidogrel use in the preoperative course of gastrointestinal surgery: a retrospective cohort study. Ann Surg 2017;265:370—378. http://dx.doi.org/10.1097/SLA.0000000000001726
Objective Our study aimed to estimate postoperative bleeding risk in older adults taking clopidogrel before gastrointestinal (GI) surgery, to aid surgeons in decisions regarding clopidogrel cessation. Summary background data Balancing risks of postoperative bleeding associated with continued clopidogrel use and those associated with cessation is difficult for GI surgeons. Methods Using 100% Texas medicare claims data from 2006 to 2011, we identified patients undergoing emergent GI surgery. We propensity score matched patients on clopidogrel before surgery to patients not on clopidogrel. Using conditional logistic regression, we compared risks of bleeding events at 1-month post-discharge between groups, adjusting for bleeding risk factors. Results
289 In total, 1240 patients undergoing emergent GI surgery while treated with clopidogrel were matched to emergency GI surgery patients not treated with clopidogrel. The only significant preoperative differences between groups were higher percent of clopidogrel-treated patients with congestive heart failure, cholecystectomy, and lower percent of clopidogrel-treated patients with colectomy. Mean age was 76.91 (± 7.06) and 76.70 (± 7.05) years (P = 0.47), and 63.84% and 59.41% of operations were cholecystectomy, in the clopidogrel and nonclopidogrel groups (P = 0.18). In multivariable analyses adjusting for Elixhauser index, hyperlipidemia, confounding drugs, and surgery type, odds ratio for bleeding within 30 days of discharge in those exposed to clopidogrel compared with those not exposed was 1.60 (95% confidence interval, 1.08—2.38), with raw rates of bleeding 6.85% and 4.84%. Conclusions Clopidogrel use in older adults through the preoperative period of GI surgery does not significantly increase bleeding events in the month after surgery. Comments 1. The conclusion of this article is, at first view, surpris® ing in that it shows that clopidogrel (Plavix ) negatively impacted hemorrhagic complications. Nonetheless, it is understandable that the clinical significance of this risk is medically speaking moderate, even if there was a statistically significant difference, notwithstanding the potential cardio-embolic complications related to the ® indication of Plavix . It is therefore premature to spread this message without any data on the thrombo-embolism complication rate. 2. To formulate their conclusions, the authors considered that their population of patients, aged over 66 and undergoing emergency operation, was at high risk for hemorrhagic complications and that, finally the increased risk of complications generated by taking ® Plavix was very small in this high risk population. However, the number of patients who died postoperatively from a hemorrhagic complication was not provided, and in the absence of analysis, this leaves a doubt as to the ® true impact of Plavix on early mortality. Moreover, even after adjustment, the two groups were not comparable concerning the rate of emergency cholecystectomies, and this variable appeared to be a protective factor against hemorrhagic complications in multivariable analysis. 3. Even if this dogma is about to fall, further studies are necessary to prove or disprove these results.
Imai K, Allard MA, Castro Benitez C, et al. Long-term outcomes of radiofrequency ablation combined with hepatectomy compared with hepatectomy alone for colorectal liver metastases. Br J Surg 2017;104:570—579. http://dx.doi.org/10.1002/bjs.10447
Background Although recent advances in surgery and chemotherapy have increasingly enabled hepatectomy in patients with initially unresectable colorectal liver metastases (CRLM), not all such patients benefit from surgery. The aim of this study was to develop a nomogram to predict survival after hepatectomy for initially unresectable CRLM. Methods Patients with initially unresectable CRLM treated with chemotherapy followed by hepatectomy between 1990 and
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2012 were included in the study. A nomogram to predict survival was developed based on a multivariable Cox model. The predictive performance of the model was assessed according to the C-statistic, Kaplan-Meier curve and calibration plots. Results Of a total of 439 patients, liver and globally completed surgery was achieved in 380 (86.6 per cent) and 335 (76.3 per cent) patients respectively. The 5-year overall and diseasefree survival rates were 39.9 and 10.0 per cent respectively. Based on the Cox model, the following five factors were selected for the nomogram and assigned specific scores: node-positive primary, 5; more than six metastases at hepatectomy, 7; carbohydrate antigen 19-9 level at hepatectomy above 37 units/mL, 10; disease progression during first-line chemotherapy, 9; and presence of extrahepatic disease, 4. The model achieved relatively good discrimination and calibration, with a C-statistic of 0.66. The overall survival rate for patients with a score greater than 16 was significantly worse than that for patients with a score of 16 or less (5-year survival rate 4 versus 46.3 per cent respectively; P < 0.001). Conclusion The nomogram facilitates personalized assessment of prognosis for patients with initially unresectable CRLM treated with chemotherapy and with planned resection. Comments 1. From a purely theoretical point of view, radio-frequency ablation (RFA) was less effective than resection, as seen by the higher in situ recurrence rate in the group undergoing RFA, but the consequences for the patient were relatively harmless as the recurrence-free and overall survival rates were not affected. This is largely due to the fact that in situ recurrence is rarely isolated and often associated with multiple intra-hepatic recurrences. 2. This study validates the concept that RFA can potentially increase the number of patients undergoing surgery with curative intent, because all the patients in the RFA group would not have been able to undergo resection without the previous effect of RFA. This study goes in the same direction as the EORTC CLOCC trial that already showed that RFA allowed good local control of liver colorectal metastases treated previously by chemotherapy [1]. 3. These conclusions are in contradiction with another, older study from M D Anderson that showed that the prognosis of patients with hepatectomy combined with RFA was less favorable that that of patients undergoing resection alone [2]. This difference might be explained by the fact that here, (i) 97% of patients undergoing RFA had metastatic disease that was well controlled by preoperative chemotherapy and (ii) the propensity score allowed a comparison of two fairly similar groups. 4. In this study, important data are missing concerning postoperative chemotherapy. Effectively, we do not know if the two groups were comparable with regard to the administration of postoperative chemotherapy and this variable was not included in the propensity score. This could have biased the comparison and it is possible that the RFA group was favored by an increased chemotherapy-related postoperative admission rate. References [1] Ann Oncol 2012;23:2619—2626. [2] Ann Surg 2004;239:450—458.
Rotenstein LS, Ramos MA, Torre M, et al. Prevalence of depression, depressive symptoms, and suicidal ideation
among medical students: a systematic review and metaanalysis. JAMA 2016;316:2214—2236. http://dx.doi.org/10.1001/jama.2016.17324
Importance Medical students are at high risk for depression and suicidal ideation. However, the prevalence estimates of these disorders vary between studies. Objective To estimate the prevalence of depression, depressive symptoms, and suicidal ideation in medical students. Data sources and study selection Systematic search of EMBASE, ERIC, MEDLINE, psycARTICLES, and psycINFO without language restriction for studies on the prevalence of depression, depressive symptoms, or suicidal ideation in medical students published before September 17, 2016. Studies that were published in the peer-reviewed literature and used validated assessment methods were included. Data extraction and synthesis Information on study characteristics; prevalence of depression or depressive symptoms and suicidal ideation; and whether students who screened positive for depression sought treatment was extracted independently by 3 investigators. Estimates were pooled using random-effects meta-analysis. Differences by study-level characteristics were estimated using stratified meta-analysis and metaregression. Main outcomes and measures Point or period prevalence of depression, depressive symptoms, or suicidal ideation as assessed by validated questionnaire or structured interview. Results Depression or depressive symptom prevalence data were extracted from 167 cross-sectional studies (n = 116,628) and 16 longitudinal studies (n = 5728) from 43 countries. All but 1 study used self-report instruments. The overall pooled crude prevalence of depression or depressive symptoms was 27.2% (37,933/122,356 individuals; 95% CI, 24.7% to 29.9%, I2 = 98.9%). Summary prevalence estimates ranged across assessment modalities from 9.3% to 55.9%. Depressive symptom prevalence remained relatively constant over the period studied (baseline survey year range of 1982—2015; slope, 0.2% increase per year [95% CI, −0.2% to 0.7%]). In the 9 longitudinal studies that assessed depressive symptoms before and during medical school (n = 2432), the median absolute increase in symptoms was 13.5% (range, 0.6% to 35.3%). Prevalence estimates did not significantly differ between studies of only preclinical students and studies of only clinical students (23.7% [95% CI, 19.5% to 28.5%] vs. 22.4% [95% CI, 17.6% to 28.2%]; P = 0.72). The percentage of medical students screening positive for depression who sought psychiatric treatment was 15.7% (110/954 individuals; 95% CI, 10.2% to 23.4%, I2 = 70.1%). Suicidal ideation prevalence data were extracted from 24 cross-sectional studies (n = 21,002) from 15 countries. All but 1 study used self-report instruments. The overall pooled crude prevalence of suicidal ideation was 11.1% (2043/21,002 individuals; 95% CI, 9.0% to 13.7%, I2 = 95.8%). Summary prevalence estimates ranged across assessment modalities from 7.4% to 24.2%. Conclusions and relevance In this systematic review, the summary estimate of the prevalence of depression or depressive symptoms among medical students was 27.2% and that of suicidal ideation was 11.1%. Further research is needed to identify
Press review strategies for preventing and treating these disorders in this population. Comments 1. This meta-analysis shows that depression is a true problem among medical students that needs to be dealt with. Of note, the prevalence of depression is higher among medical students than in the same age group in the general population [1] or among students in any other university setting [2]. 2. Missing was the analysis of potential risk factors for depression that might lead to preventive measures. Is the risk related to the pressure created by competition, the long duration of medical studies, late contact with patients revealing that the choice to study medicine was wrong, or the incertitude of where and how medical students will exercise their profession? Further studies should be conducted to answer these questions. 3. One of the problems in this article is that it was not possible to evaluate the severity and the degree of depression and the onset of manic-depressive psychosis could not be distinguished from a simple transient depressive reaction. References [1] JAMA 2003;289:3095—3105. [2] J Psychiatr Res 2013;47:391—400.
Willcutts KF, Chung MC, Erenberg CL, Finn KL, Schirmer BD, Byham-Gray LD. Early oral feeding as compared with traditional timing of oral feeding after upper gastrointestinal surgery: a systematic review and meta-analysis. Ann Surg 2016;264:54—63. http://dx.doi.org/10.1097/SLA.0000000000001644
Objective To compare the effects of early oral feeding to traditional (or late) timing of oral feeding after upper gastrointestinal surgery on clinical outcomes. Background Early postoperative oral feeding is becoming more common, particularly as part of multimodal or fast-track protocols. However, concerns remain about the safety of early oral feeding after upper gastrointestinal surgery. Methods Comprehensive literature searches were conducted across 5 databases from January 1980 until June 2015 without language restriction. Risk of bias of included studies was appraised and random-effects model meta-analyses were performed to synthesize outcomes of anastomotic leaks, pneumonia, nasogastric tube reinsertion, reoperation, readmissions, and mortality. Results Fifteen studies comprising 2112 adult patients met all the inclusion criteria. Mean hospital stay was significantly shorter in the early-fed group than in the late-fed group (weighted mean difference = −1.72 d, 95% confidence interval [CI]: −1.25 to −2.20, P < 0.01). Postoperative length of stay was also significantly shorter (weighted mean difference = −1.44 d, 95% CI: −0.68 to −2.20, P < 0.01). There was no significant difference in risk of anastomotic leak, pneumonia, nasogastric tube reinsertion, reoperation, readmission, or mortality in the randomized controlled trials (RCTs). The pooled RCT and non-RCT results, however, showed a significantly lower risk of pneumonia in early-fed as compared with late-fed group (odds ratio = 0.6, 95% CI: 0.41—0.89, P = 0.01). Conclusions
291 Early postoperative oral feeding as compared with traditional (or late) timing is associated with shorter hospital length of stay and is not associated with an increase in clinically relevant complications. Comments 1. Whereas the traditional goal of postoperative fasting with insertion of a nasogastric tube was to protect the gastrointestinal suture lines and decrease the risk of postoperative complications, this meta-analysis topples a long-standing dogma (i.e. postoperative fasting is necessary), and even suggests that early feeding within the first 24 h might decrease postoperative complications. 2. One positive point of this meta-analysis is that it included only studies that dealt with postoperative oral feeding and not those dealing with early enteral feeding with a jejunostomy or nasojejunal tube. 3. However, as in all meta-analyses, several methodological biases limit the transposition of results into daily practice: (i) randomized trials were mixed with nonrandomized trials, (ii) indications for and types of surgery performed were different (the probability of pulmonary aspiration being completely different after esophagectomy vs. pancreatectomy), (iii) absence of gradation of severity, and lack of standardization in the definition of complications, (iv) absence of blinding in these studies, leading to a potential bias in the evaluation of complications, i.e. under-estimation of the incidence of complications in the ‘‘modern’’ arm, (v) absence of precision concerning the modalities of postoperative feeding (fluids?, solids?, progression in the introduction of solids), (vi) imbalance between the percentage of gastrectomies (52%) and esophagectomies that represented only 11% of the population while hepato-biliary surgery was performed in 25% and above all, (vii) absence of data concerning the clinical situations that obviously did not influence the indications of early postoperative oral feeding, as for example, the high risk of aspiration after esophagectomy when the patient had vocal cord paralysis.
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Thromboprophylaxie après chirurgie bariatrique : pour quels patients ? Aminian A, Andalib A, Khorgami Z, et al. Who Should get extended thromboprophylaxis after bariatric surgery? A risk assessment tool to guide indications for post-discharge pharmacoprophylaxis. Ann Surg 2017;265:143—150. http://dx.doi.org/10.1097/SLA.0000000000001686
Objective To determine the risk factors for 30-day post-discharge venous thromboembolism (VTE) after bariatric surgery and to identify potential indications for extended pharmacoprophylaxis. Background VTE is among most common causes of death after bariatric surgery. Most VTEs occur after hospital stay; still a few patients receive extended pharmacoprophylaxis postdischarge. Methods From American College of Surgeons-National Surgical Quality Improvement Program, we identified 91,963 patients, who underwent elective primary and revisional bariatric surgery between 2007 and 2012. Regression-based techniques were used to create a risk assessment tool to
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predict risk of post-discharge VTE. The model was validated using the 2013 American College of Surgeons-National Surgical Quality Improvement Program dataset (n = 20,575). Significant risk factors were used to create a user-friendly online risk calculator. Results The overall 30-day incidence of post-discharge VTE was 0.29% (n = 269). In those experiencing a post-discharge VTE, mortality increased about 28-fold (2.60% vs. 0.09%; P < 0.001). Among 45 examined variables, the final riskassessment model contained 10 categorical variables including congestive heart failure, paraplegia, reoperation, dyspnea at rest, nongastric band surgery, age ≥ 60 years, male sex, BMI ≥ 50 kg/m, postoperative hospital stay ≥ 3 days, and operative time ≥ 3 hours. The model demonstrated good calibration (Hosmer-Lemeshow goodness-of-fit test, P = 0.71) and discrimination (c-statistic = 0.74). Nearly 2.5% of patients had a predicted post-discharge VTE risk > 1%. Conclusions More than 80% of post-bariatric surgery VTE events occurred post-discharge. Congestive heart failure, paraplegia, dyspnea at rest, and reoperation are associated with the highest risk of post-discharge VTE. Routine post-discharge pharmacoprophylaxis can be considered for high-risk patients (i.e., VTE risk > 0.4%). Comments 1. Bariatric surgery has developed in parallel to the epidemic increasing incidence of morbid obesity, with a small but non-negligible risk of complications, especially thromboembolic complications (TEC): 1 to 3% of deep venous complications and 0.3 to 2% of pulmonary embolism [1,2]. 2. This study highlights the fact that TEC are not exceptional and above all, that in 80% of cases, they occur after patient discharge, justifying prolonged mechanical and/or pharmacologic prophylaxis in patients at risk. This explains the pertinent drive of the authors to identify the mostly patient-related risk factors for TEC after bariatric surgery, in order to propose a targeted preventive approach. 3. As a comparison, thromboembolic prophylaxis is recommended for 28 days after surgery for cancer [3]. 4. The modalities of thromboembolic prophylaxis remain vague in the context of bariatric surgery, and in particular, the dosage with respect to increased body surface. 5. As is the case with all administrative data bases, a certain number of limitations have to be underscored: (i) the possibility that all TEC were not reported, (ii) absence of certain descriptive data such as contraceptive medications, antecedent history of TEC, existence of constitutional coagulation disorders (antiphospholipid syndrome, Leiden factor V. . .), existence of a central vascular line, early postoperative complications such as anastomotic fistula that increase the risk of TEC. . . References [1] Obes Surg 2003;13:819—825. [2] N Engl J Med 2009;361:445—454. [3] Thromb Res 2014;133:985—992.
Roman-Gonzalez A, Zhou S, Ayala-Ramirez M et al. Impact of surgical resection of the primary tumor on overall survival in patients with metastatic pheochromocytoma or sympathetic paraganglioma. Ann Surg 2017; Ahead of Print. http://dx.doi.org/10.1097/SLA.0000000000002195
Objective To determine whether primary tumor resection in patients with metastatic pheochromocytoma or paraganglioma (PPG) is associated with longer overall survival (OS). Background Patients with metastatic PPG have poor survival outcomes. The impact of surgical resection of the primary tumor on OS is not known. Methods We retrospectively studied patients with metastatic PPG treated at the University of Texas, MD Anderson Cancer Center from January 2000 through January 2015. Kaplan-Meier analysis with log-rank tests was used to compare OS among patients undergoing primary tumor resection and patients not treated surgically. Propensity score method was applied to adjust for selection bias using demographic, clinical, biochemical, genetic, imaging, and pathologic information. Results A total of 113 patients with metastatic PPG were identified. Eighty-nine (79%) patients had surgery and 24 (21%) patients did not. Median OS was longer in patients who had surgery than in patients who did not [148 months, 95% confidence interval (CI): 112.8—183.2 months vs. 36 months, 95% CI: 27.2—44.8 months; P < 0.001]. Fifty-three (46%) patients had synchronous metastases; of these patients, those who had surgery had longer OS than those who did not (85 months, 95% CI: 64.5—105.4 months vs. 36 months, 95% CI: 29.7—42.3 months; P < 0.001). Patients who had surgery had a similar ECOG performance status to the ones who did not (P = 0.1798, two sample t-test; P = 0.2449, Wilcoxon rank sum test). Univariate and propensity score analysis confirmed that patients treated with surgery had longer OS than those not treated surgically irrespective of age, race, primary tumor size and location, number of metastatic sites, and genetic background (log-rank P < 0.001). In patients with hormonally active tumors (70.8%), the symptoms of catecholamine excess improved after surgery. However, the tumor burden was a more important determinant of OS than hormonal secretion. Conclusions Primary tumor resection in patients with metastatic PPG appeared to be associated with improved OS. In patients with hormonally active tumors, surgical resection led to better blood pressure control. Comments 1. This study is very important because it shows for the first time that resection of the primary tumor in patients with metastatic pheochromocytoma impacts overall survival favorably. These data should lead to modification of the current management of these tumors. This strategy of primary tumor resection has been validated for small intestinal endocrine tumors and is under discussion for pancreatic endocrine tumors [1]. 2. The number of patients included is impressive for this rare type of tumor. As the duration of inclusion was 15 years, the group can be considered chronologically homogeneous and gives some weight to the conclusions [2]. 3. Interestingly, the type of resection of the primitive tumor (R0, R1 or R2) did not impact overall survival. Therefore tumor mass reduction is more important as a determinant factor for survival than the completeness of the procedure. 4. Because of the small number of patients, this study cannot answer the question of whether to incorporate one or several procedures for resection of metastases at the same time as surgery on the primary tumor.
Press review References [1] Surgery 2014;155:607—14. [2] Ann Surg 2016;263:582—7.
Watson AJ, Hudson J, Wood J et al. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial. Lancet 2016;388:2375—2385. http://dx.doi.org/10.1016/S0140-6736(16)31803-7
Background Two commonly performed surgical interventions are available for severe (grade II—IV) hemorrhoids; traditional excisional surgery and stapled hemorrhoidopexy. Uncertainty exists as to which is most effective. The eTHoS trial was designed to establish the clinical effectiveness and costeffectiveness of stapled hemorrhoidopexy compared with traditional excisional surgery. Methods The eTHoS trial was a large, open-label, multicenter, parallel-group, pragmatic randomized controlled trial done in adult participants (aged 18 years or older) referred to hospital for surgical treatment for grade II—IV hemorrhoids. Participants were randomly assigned (1:1) to receive either traditional excisional surgery or stapled hemorrhoidopexy. Randomization was minimized according to baseline EuroQol 5 dimensions 3 level score (EQ-5D-3L), hemorrhoid grade, sex, and center with an automated system to stapled hemorrhoidopexy or traditional excisional surgery. The primary outcome was area under the quality of life curve (AUC) measured with the EQ-5D-3L descriptive system over 24 months, assessed according to the randomized groups. The primary outcome measure was analyzed using linear regression with adjustment for the minimization variables. This trial is registered with the ISRCTN registry, number ISRCTN80061723. Findings Between Jan 13, 2011, and Aug 1, 2014, 777 patients were randomized (389 to receive stapled hemorrhoidopexy and 388 to receive traditional excisional surgery). Stapled hemorrhoidopexy was less painful than traditional excisional surgery in the short term and surgical complication rates were similar between groups. The EQ-5D-3L AUC score was higher in the traditional excisional surgery group than the stapled hemorrhoidopexy group over 24 months; mean difference −0.073 (95% CI: −0.140 to −0.006; P = 0.0342). EQ-5D-3L was higher for stapled hemorrhoidopexy in the first 6 weeks after surgery, the traditional excisional surgery group had significantly better quality of life scores than the stapled hemorrhoidopexy group. In total, 24 (7%) of 338 participants who received stapled hemorrhoidopexy and 33 (9%) of 352 participants who received traditional excisional surgery had serious adverse events. Interpretation As part of a tailored management plan for hemorrhoids, traditional excisional surgery should be considered over stapled hemorrhoidopexy as the surgical treatment of choice. Comments 1. With respect to the prevalence of hemorrhoid surgery that represents around 25,000 interventions per year in the English National Health System, this randomized trial is important and marks a milestone, showing that the classical Milligan and Morgan operation, assuredly more painful in the short term, is more effective in the longterm with less recurrence, better quality of life and costeffectiveness.
293 2. This trial underscores the value of rigorous evaluation in surgical innovation, in order not to ride on the wave of technological modernism if it does not provide the proof of major benefit for the patient, especially when the societal cost is higher. 3. As there was no statistically significant difference found concerning the duration of operation or hospital stay, or the percentage of patients returning to professional activity at six weeks, the stapled hemorrhoidopexy has lost some of its aura, especially when one compares the continence scores at 24 months, which are better with the traditional excisional operation of Milligan and Morgan. 4. Among the limitations, we note: absence of blinding in the evaluation and missing data in the 24-month functional outcome evaluation.
Aquina CT, Becerra AZ, Probst CP, et al. Patients with adhesive small bowel obstruction should be primarily managed by a surgical team. Ann Surg 2016;264:437—47. http://dx.doi.org/10.1097/SLA.0000000000001861
Objective To evaluate the impact of a primary medical versus surgical service on healthcare utilization and outcomes for adhesive small bowel obstruction (SBO) admissions. Summary background data Adhesive-SBO typically requires hospital admission and is associated with high healthcare utilization and costs. Given that most patients are managed nonoperatively, many patients are admitted to medical hospitalists. However, comparisons of outcomes between primary medical and surgical services have been limited to small single-institution studies. Methods Unscheduled adhesive-SBO admissions in NY State from 2002 to 2013 were identified using the Statewide Planning and Research Cooperative System. Bivariate and mixedeffects regression analyses were performed assessing factors associated with healthcare utilization and outcomes for SBO admissions. Results Among 107,603 admissions for adhesive-SBO (78% nonoperative, 22% operative), 43% were primarily managed by a medical attending and 57% were managed by a surgical attending. After controlling for patient, physician, and hospital-level factors, management by a medical service was independently associated with longer length of stay [IRR = 1.39, 95% confidence interval (CI) = 1.24, 1.56], greater inpatient costs (IRR = 1.38, 95% = 1.21, 1.57), and a higher rate of 30-day readmission (OR = 1.32, 95% CI = 1.22, 1.42) following nonoperative management. Similarly, of those managed operatively, management by a medicine service was associated with a delay in time to surgical intervention (IRR = 1.84, 95% CI = 1.69, 2.01), extended length of stay (IRR = 1.36, 95% CI = 1.25, 1.49), greater inpatient costs (IRR = 1.38, 95% CI = 1.11, 1.71), and higher rates of 30-day mortality (OR = 1.92, 95% CI = 1.50, 2.47) and 30-day readmission (OR = 1.13, 95% CI = 0.97, 1.32). Conclusions This study suggests that management of patients presenting with adhesive-SBO by a primary medical team is associated with higher healthcare utilization and worse perioperative outcomes. Policies favoring primary management
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by a surgical service may improve outcomes and reduce costs for patients admitted with adhesive-SBO. Comments 1. While adhesive intestinal obstruction is associated with repeated hospitalizations, and costly care, this population study suggests that primary management by a surgical team and early surgery (versus conservative medical treatment) provides better outcomes and reduces costs of care. 2. This study, the largest to date, and the first populationbased study, confirms the results of other studies with samples ranging from 65 to 635 cases, i.e. that early surgery is better [1—4]. 3. As is the case with other administrative data base studies, there are limitations such as absence of variables such as vital signs upon admission, antecedent medical and surgical history, data concerning the clinical and biological investigations as well as the quality of coding. 4. Likewise, it would have been useful to know the criteria used to choose one or another treatment from the patient’s and the attending physician’s viewpoint. References [1] Ann Surg 2001;67:1034—1038. [2] Surgery 2001;130:706—711. [3] Am Surg 2010;76:687—691. [4] J Am Coll Surg 2015;221:7—13.
Lazzati A, De Antonio M, Paolino L, et al. Natural history of adjustable gastric banding: lifespan and revisional rate: a nationwide study on administrative data on 53,000 patients. Ann Surg 2017;265:439—445. http://dx.doi.org/10.1097/SLA.0000000000001879
Objective The aim of this study was to analyze the adjustable gastric banding (AGB) natural history on a national basis. Background Adjustable gastric banding represented the most common bariatric procedure in France until 2010. Since then, the number of AGBs has decreased and the rate of band removal and revisional surgeries has progressively increased. Methods For analysis, we included all adult patients operated on with AGB in France between 2007 and 2013. Data were extracted from a national administrative database (‘‘Programme de médicalisation des systèmes
d’information’’ [PMSI]), which is an exhaustive source of all surgical procedures performed in France. The Cox proportional hazard model was used to test univariate and multivariate associations with band survival and revisional rate. To control for center-specific effects, we performed a frailty analysis, in which each center was assumed to have a random effect indicating the possibility of different baseline risks for patients at different centers. Results During the study period, 52,868 patients underwent AGB, and 10,815 bands were removed. The removal rate at 5, 6, and 7 years was 28%, 34%, and 40%, respectively. Female sex, body mass index > 50 kg/m, type 2 diabetes, hypertension, dyslipidemia, and sleep apnea were found to be significantly associated with band removal by multivariate analysis. A significant center effect was also found, but this did not change the impact of the highly significant factors already identified. After band removal, the median time to revisional surgery was 1 year (95% confidence interval: 1.0—1.1) and the conversion rate at 7 years was 71%. Conclusions With a removal rate of about 6% annually and the need for revisional surgery for more than two-thirds of patients after removal, AGB does not appear to provide a long-term solution for obesity. Comments 1. This high-quality population-based study consolidates the clinical impression and the results of other small sample studies [1,2], that is, that adjustable gastric banding (AGB) is associated with high rates of band removal and revisional surgery and opens the door for other procedures to treat morbid obesity. 2. Of note, the authors used the ablation rate as their main endpoint, while excess weight loss and/or resolution of co-morbidity are the most widely used dependent variables. 3. The main limitation of this study is the absence of information as to the cause for band removal. References [1] Obes Surg 2004;14:1343—1348. [2] Arch Surg 2011;146:802—807.
Disclosure of interest The authors declare that they have no competing interest.
Available online at
ScienceDirect www.sciencedirect.com
Press review C. Mariette a,∗, S. Benoist b, L. Brunaud c a
Service de chirurgie digestive et générale, hôpital C.-Huriez, CHRU, place de Verdun, 59037 Lille cedex, France b Service de chirurgie digestive, hôpital du Kremlin-Bicêtre, 78, rue du Général-Leclerc, 94275 Le Kremlin-Bicêtre, France c Service de chirurgie digestive, hôpital Brabois, CHRU de Nancy, rue du Morvan, 54500 Vandoeuvre-les-Nancy, France Available online 1 August 2017
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Intérêt d’une sigmoïdectomie élective en cas de douleur chronique ou de crises rapprochées après une première poussée de diverticulite non compliquée : résultats d’un essai contrôlé hollandais multicentrique van de Wall BJ, Stam MA, Draaisma WA, et al. Surgery versus conservative management for recurrent and ongoing left-sided diverticulitis (DIRECT trial): an open-label, multicentre, randomised controlled trial. Lancet Gastroenterol Hepatol 2017;2:13—22. http://dx.doi.org/10.1016/S2468-1253(16)30109-1
Background Patients with recurrent or persisting complaints after an episode of left-sided diverticulitis are managed with either conservative measures or elective sigmoidectomy. To date, there are no data from randomized trials. We aimed to establish which treatment leads to a better quality of life for patients with diverticulitis. Methods We did an open-label, multicenter, randomized controlled trial (DIRECT trial) in 24 teaching and two academic hospitals in the Netherlands. Patients aged 18—75 years presenting with either recurrent (three or more presentations with clinical signs of acute diverticulitis within 2 years) or persistent abdominal complaints (ongoing lower left abdominal pain or persistent change in bowel habits for ≥ 3 months) after an episode of left-sided diverticulitis, confirmed by CT, ultrasound, or endoscopy, were
∗
Corresponding author. E-mail address: [email protected] (C. Mariette).
1878-7886/$ — see front matter http://dx.doi.org/10.1016/j.jviscsurg.2017.06.007
included. Patients were excluded if they had previous elective or emergency surgery for acute sigmoid diverticulitis, an absolute operation indication, suspicion of a colorectal malignancy, with a preoperative or postoperative risk greater than III (on the American Society of Anesthesiologists classification), or were unable to complete questionnaire or follow-up. Patients were randomly assigned (3:3) to receive conservative management or elective (laparoscopic) sigmoidectomy using a digital randomization system, stratified by type of disease and center, with a block size of six. Patients, physicians, and researchers were not masked to treatment allocation. Our primary endpoint was healthrelated quality of life, measured by the Gastrointestinal Quality of Life Index (GIQLI) at 6 months after inclusion or surgery, depending on randomization group. This trial is registered with trialregister.nl, number NTR1478, and is closed for inclusion. Findings Between July 1, 2010, and April 1, 2014, we randomly assigned 109 patients to receive surgical treatment (resection; n = 53) or conservative management (n = 56), after which the Data Safety and Monitoring Board prematurely terminated the trial because of increasing difficulties in recruitment. In total, 47 (89%) of 53 patients received surgical treatment and 43 (77%) of 56 patients received conservative management. The GIQLI score at 6 months’ follow-up was significantly higher in patients randomly assigned to receive surgical treatment (mean 114.4 [SD 22.3]) than conservative management (100.4 [22.7]; mean difference 14.2, 95% CI: 7.2—21.1, P < 0.0001). In total, 43 (38%) of 109 patients had a severe adverse event in the first 6 months after treatment (18 [34%] of 53 patients in the surgical treatment group vs. 23 [40%] of 57 patients
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in the conservative treatment group). Seven (15%) patients who received surgical treatment developed anastomotic leakage. Of the 56 patients assigned to be treated conservatively, 13 (23%) ultimately underwent elective resection due to ongoing abdominal complaints, with no anastomotic leakage. We recorded no patient deaths. Interpretation Elective sigmoidectomy, despite its inherent risk of complications, results in better quality of life than conservative management in patients with recurrent and persisting abdominal complaints after an episode of diverticulitis. Comments 1. This trial was terminated early because of insufficient accrual and included only 109 of the 214 initially planned patients. However, with clinically pertinent and statistical significance, this trial favors prophylactic surgery for diverticular disease in these indications. 2. If only by the existence of the trial, it is probable that the surgical group benefited from a placebo effect, all the more so since no real treatment was proposed in the control arm. 3. The six-month delay to evaluate the quality of life seems rather short; it would have been of interest to know if this difference persisted in the longer term. 4. The permanent stoma rate, often given as an argument against prophylactic surgery, was low, less than 2%. On the other hand, the temporary stoma rate was 19%, particularly high for left colectomy with intra-peritoneal anastomoses. 5. It would now be interesting to run a new randomized trial assessing the value of prophylactic surgery in patients having sustained a first flare of diverticulitis with abscess or micro-perforation treated medically with success. Danielsen AK, Park J, Jansen JE, et al. Early closure of a temporary ileostomy in patients with rectal cancer: a multicenter randomized controlled trial. Ann Surg 2017;265:284—290. http://dx.doi.org/10.1097/SLA.0000000000001829
Objective The objective was to study morbidity and mortality associated with early closure (8—13 days) of a temporary stoma compared with standard procedure (closure after > 12 weeks) after rectal resection for cancer. Background A temporary ileostomy may reduce the risk of pelvic sepsis after anastomotic dehiscence. However, the temporary ileostomy is afflicted with complications and requires a second surgical procedure (closure) with its own complications. Early closure of the temporary ileostomy could reduce complications for rectal cancer patients. Methods Early closure (8—13 days after stoma creation) of a temporary ileostomy was compared with late closure (> 12 weeks) in a multicenter randomized controlled trial, EASY (www.clinicaltrials.gov, NCT01287637) including patients undergoing rectal resection for cancer. Patients with a temporary ileostomy without signs of postoperative complications were randomized to closure at 8 to 13 days or late closure (> 12 weeks after index surgery). Clinical data were collected up to 12 months. Complications were registered according to the Clavien-Dindo Classification of Surgical Complications, and Comprehensive Complication Index was calculated. Results
The trial included 127 patients in eight Danish and Swedish surgical departments, and 112 patients were available for analysis. The mean number of complications after index surgery up to 12 months follow-up was significantly lower in the intervention group (1.2) compared with the control group (2.9), P < 0.0001. Conclusions It is safe to close a temporary ileostomy 8 to 13 days after rectal resection and anastomosis for rectal cancer in selected patients without clinical or radiological signs of anastomotic leakage. Comments 1. The conclusions of this trial must be interpreted with caution because the methodology is, for the least, surprising. First of all, the calculation of the number of patients necessary was based on the hypothesis that early closure (vs. late closure) would decrease the complication rate by 62%, whereas the only available controlled trial in the literature, more powerful, found that early closure did not lead to less overall morbidity [1]. Moreover, the analysis was not performed with intention to treat as 15 patients, that is, 11% of the initial sample, were withdrawn from analysis after randomization for unclear reasons. Last, we can consider that the trial was artificially positive by protocol violation. Effectively, in the group undergoing late closure, ileostomy should have been closed within 12 weeks but in fact, the median delay for closure was 18.5 weeks. Maintaining an ileostomy longer than planned could have contributed to the increased stoma-related complication rate. 2. The population in this study was highly selected: only 30% of potentially eligible patients were included. The main reason seems to be medical, but no clear explanation was given. This suggests that most patients were in poor physical condition eight days after proctectomy, and were not inclined, even in the absence of fistula, to undergo a second intervention so quickly. 3. If a third trial on the topic were to surface, a main end point of quality of life might be much more pertinent. Reference [1] Br J Surg 2008;95:693—698.
Roulin D, Saadi A, Di Mare L, et al. Early versus delayed cholecystectomy for acute cholecystitis, are the 72 hours still the rule? A randomized trial. Ann Surg 2016;264:717—722. http://dx.doi.org/10.1097/SLA.0000000000001886
Objective The aim of this study was to compare clinical outcomes of early versus delayed laparoscopic cholecystectomy (LC) in acute cholecystitis with more than 72 hours of symptoms. Background LC is the treatment of acute cholecystitis, with consensus recommendation that patients should be operated within 72 hours of evolution. Data however remain weak with no prospective study focusing on patients beyond 72 hours of symptoms. Methods Patients with acute cholecystitis and more than 72 hours of symptoms were randomly assigned to early LC (ELC) or delayed LC (DLC). ELC was performed following hospital admission. DLC was planned at least 6 weeks after initial antibiotic treatment. Primary outcome was overall morbidity following initial diagnosis. Secondary outcomes were
Press review total length of stay, duration of antibiotic therapy, hospital costs, and surgical outcome. Results Eighty-six patients were randomized (42 in ELC and 44 in DLC group). Overall, morbidity was lower in ELC [6 (14%) vs. 17 (39%) patients, P = 0.015]. Median total length of stay (4 vs. 7 days, P < 0.001) and duration of antibiotic therapy (2 vs. 10 days, P < 0.001) were shorter in the ELC group. Total hospital costs were lower in ELC (9349&OV0556; vs. 12,361 &OV0556;, P = 0.018). Operative time and postoperative complications were similar (91 vs. 88 min; P = 0.910) and (15% vs. 17%; P = 1.000), respectively. Conclusions ELC for acute cholecystitis even beyond 72 hours of symptoms is safe and associated with less overall morbidity, shorter total hospital stay, and duration of antibiotic therapy, as well as reduced cost compared with delayed cholecystectomy (NCT01548339). Comments 1. Initially the authors had planned a non-inferiority study but when the intermediary analysis showed that early cholecystectomy was so much better, they decided to transform the methodology to a superiority trial. 2. The conversion rate in the early cholecystectomy group was particularly low, compared to the 10—15% rates usually reported for acute cholecystitis [1—3], and therefore it is difficult to understand how all the included patients had cholecystitis of 72 h duration. As the inclusion criteria were based on patient history, it is possible that these patients had pain due only to biliary colic initially and that cholecystitis set in later. This inclusion bias might have considerably favored the outcome in the group undergoing early cholecystectomy. 3. Because of the monocenter character of this study, the reproducibility of results remains to be shown. References [1] Br J Surg 2015;102:1302—1313. [2] Ann Surg 2011;254:964—970. [3] JAMA Surg 2015;150:129—136.
Jupiter DC, Fang X, Adhikari D, et al. Safety of continued clopidogrel use in the preoperative course of gastrointestinal surgery: a retrospective cohort study. Ann Surg 2017;265:370—378. http://dx.doi.org/10.1097/SLA.0000000000001726
Objective Our study aimed to estimate postoperative bleeding risk in older adults taking clopidogrel before gastrointestinal (GI) surgery, to aid surgeons in decisions regarding clopidogrel cessation. Summary background data Balancing risks of postoperative bleeding associated with continued clopidogrel use and those associated with cessation is difficult for GI surgeons. Methods Using 100% Texas medicare claims data from 2006 to 2011, we identified patients undergoing emergent GI surgery. We propensity score matched patients on clopidogrel before surgery to patients not on clopidogrel. Using conditional logistic regression, we compared risks of bleeding events at 1-month post-discharge between groups, adjusting for bleeding risk factors. Results
289 In total, 1240 patients undergoing emergent GI surgery while treated with clopidogrel were matched to emergency GI surgery patients not treated with clopidogrel. The only significant preoperative differences between groups were higher percent of clopidogrel-treated patients with congestive heart failure, cholecystectomy, and lower percent of clopidogrel-treated patients with colectomy. Mean age was 76.91 (± 7.06) and 76.70 (± 7.05) years (P = 0.47), and 63.84% and 59.41% of operations were cholecystectomy, in the clopidogrel and nonclopidogrel groups (P = 0.18). In multivariable analyses adjusting for Elixhauser index, hyperlipidemia, confounding drugs, and surgery type, odds ratio for bleeding within 30 days of discharge in those exposed to clopidogrel compared with those not exposed was 1.60 (95% confidence interval, 1.08—2.38), with raw rates of bleeding 6.85% and 4.84%. Conclusions Clopidogrel use in older adults through the preoperative period of GI surgery does not significantly increase bleeding events in the month after surgery. Comments 1. The conclusion of this article is, at first view, surpris® ing in that it shows that clopidogrel (Plavix ) negatively impacted hemorrhagic complications. Nonetheless, it is understandable that the clinical significance of this risk is medically speaking moderate, even if there was a statistically significant difference, notwithstanding the potential cardio-embolic complications related to the ® indication of Plavix . It is therefore premature to spread this message without any data on the thrombo-embolism complication rate. 2. To formulate their conclusions, the authors considered that their population of patients, aged over 66 and undergoing emergency operation, was at high risk for hemorrhagic complications and that, finally the increased risk of complications generated by taking ® Plavix was very small in this high risk population. However, the number of patients who died postoperatively from a hemorrhagic complication was not provided, and in the absence of analysis, this leaves a doubt as to the ® true impact of Plavix on early mortality. Moreover, even after adjustment, the two groups were not comparable concerning the rate of emergency cholecystectomies, and this variable appeared to be a protective factor against hemorrhagic complications in multivariable analysis. 3. Even if this dogma is about to fall, further studies are necessary to prove or disprove these results.
Imai K, Allard MA, Castro Benitez C, et al. Long-term outcomes of radiofrequency ablation combined with hepatectomy compared with hepatectomy alone for colorectal liver metastases. Br J Surg 2017;104:570—579. http://dx.doi.org/10.1002/bjs.10447
Background Although recent advances in surgery and chemotherapy have increasingly enabled hepatectomy in patients with initially unresectable colorectal liver metastases (CRLM), not all such patients benefit from surgery. The aim of this study was to develop a nomogram to predict survival after hepatectomy for initially unresectable CRLM. Methods Patients with initially unresectable CRLM treated with chemotherapy followed by hepatectomy between 1990 and
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2012 were included in the study. A nomogram to predict survival was developed based on a multivariable Cox model. The predictive performance of the model was assessed according to the C-statistic, Kaplan-Meier curve and calibration plots. Results Of a total of 439 patients, liver and globally completed surgery was achieved in 380 (86.6 per cent) and 335 (76.3 per cent) patients respectively. The 5-year overall and diseasefree survival rates were 39.9 and 10.0 per cent respectively. Based on the Cox model, the following five factors were selected for the nomogram and assigned specific scores: node-positive primary, 5; more than six metastases at hepatectomy, 7; carbohydrate antigen 19-9 level at hepatectomy above 37 units/mL, 10; disease progression during first-line chemotherapy, 9; and presence of extrahepatic disease, 4. The model achieved relatively good discrimination and calibration, with a C-statistic of 0.66. The overall survival rate for patients with a score greater than 16 was significantly worse than that for patients with a score of 16 or less (5-year survival rate 4 versus 46.3 per cent respectively; P < 0.001). Conclusion The nomogram facilitates personalized assessment of prognosis for patients with initially unresectable CRLM treated with chemotherapy and with planned resection. Comments 1. From a purely theoretical point of view, radio-frequency ablation (RFA) was less effective than resection, as seen by the higher in situ recurrence rate in the group undergoing RFA, but the consequences for the patient were relatively harmless as the recurrence-free and overall survival rates were not affected. This is largely due to the fact that in situ recurrence is rarely isolated and often associated with multiple intra-hepatic recurrences. 2. This study validates the concept that RFA can potentially increase the number of patients undergoing surgery with curative intent, because all the patients in the RFA group would not have been able to undergo resection without the previous effect of RFA. This study goes in the same direction as the EORTC CLOCC trial that already showed that RFA allowed good local control of liver colorectal metastases treated previously by chemotherapy [1]. 3. These conclusions are in contradiction with another, older study from M D Anderson that showed that the prognosis of patients with hepatectomy combined with RFA was less favorable that that of patients undergoing resection alone [2]. This difference might be explained by the fact that here, (i) 97% of patients undergoing RFA had metastatic disease that was well controlled by preoperative chemotherapy and (ii) the propensity score allowed a comparison of two fairly similar groups. 4. In this study, important data are missing concerning postoperative chemotherapy. Effectively, we do not know if the two groups were comparable with regard to the administration of postoperative chemotherapy and this variable was not included in the propensity score. This could have biased the comparison and it is possible that the RFA group was favored by an increased chemotherapy-related postoperative admission rate. References [1] Ann Oncol 2012;23:2619—2626. [2] Ann Surg 2004;239:450—458.
Rotenstein LS, Ramos MA, Torre M, et al. Prevalence of depression, depressive symptoms, and suicidal ideation
among medical students: a systematic review and metaanalysis. JAMA 2016;316:2214—2236. http://dx.doi.org/10.1001/jama.2016.17324
Importance Medical students are at high risk for depression and suicidal ideation. However, the prevalence estimates of these disorders vary between studies. Objective To estimate the prevalence of depression, depressive symptoms, and suicidal ideation in medical students. Data sources and study selection Systematic search of EMBASE, ERIC, MEDLINE, psycARTICLES, and psycINFO without language restriction for studies on the prevalence of depression, depressive symptoms, or suicidal ideation in medical students published before September 17, 2016. Studies that were published in the peer-reviewed literature and used validated assessment methods were included. Data extraction and synthesis Information on study characteristics; prevalence of depression or depressive symptoms and suicidal ideation; and whether students who screened positive for depression sought treatment was extracted independently by 3 investigators. Estimates were pooled using random-effects meta-analysis. Differences by study-level characteristics were estimated using stratified meta-analysis and metaregression. Main outcomes and measures Point or period prevalence of depression, depressive symptoms, or suicidal ideation as assessed by validated questionnaire or structured interview. Results Depression or depressive symptom prevalence data were extracted from 167 cross-sectional studies (n = 116,628) and 16 longitudinal studies (n = 5728) from 43 countries. All but 1 study used self-report instruments. The overall pooled crude prevalence of depression or depressive symptoms was 27.2% (37,933/122,356 individuals; 95% CI, 24.7% to 29.9%, I2 = 98.9%). Summary prevalence estimates ranged across assessment modalities from 9.3% to 55.9%. Depressive symptom prevalence remained relatively constant over the period studied (baseline survey year range of 1982—2015; slope, 0.2% increase per year [95% CI, −0.2% to 0.7%]). In the 9 longitudinal studies that assessed depressive symptoms before and during medical school (n = 2432), the median absolute increase in symptoms was 13.5% (range, 0.6% to 35.3%). Prevalence estimates did not significantly differ between studies of only preclinical students and studies of only clinical students (23.7% [95% CI, 19.5% to 28.5%] vs. 22.4% [95% CI, 17.6% to 28.2%]; P = 0.72). The percentage of medical students screening positive for depression who sought psychiatric treatment was 15.7% (110/954 individuals; 95% CI, 10.2% to 23.4%, I2 = 70.1%). Suicidal ideation prevalence data were extracted from 24 cross-sectional studies (n = 21,002) from 15 countries. All but 1 study used self-report instruments. The overall pooled crude prevalence of suicidal ideation was 11.1% (2043/21,002 individuals; 95% CI, 9.0% to 13.7%, I2 = 95.8%). Summary prevalence estimates ranged across assessment modalities from 7.4% to 24.2%. Conclusions and relevance In this systematic review, the summary estimate of the prevalence of depression or depressive symptoms among medical students was 27.2% and that of suicidal ideation was 11.1%. Further research is needed to identify
Press review strategies for preventing and treating these disorders in this population. Comments 1. This meta-analysis shows that depression is a true problem among medical students that needs to be dealt with. Of note, the prevalence of depression is higher among medical students than in the same age group in the general population [1] or among students in any other university setting [2]. 2. Missing was the analysis of potential risk factors for depression that might lead to preventive measures. Is the risk related to the pressure created by competition, the long duration of medical studies, late contact with patients revealing that the choice to study medicine was wrong, or the incertitude of where and how medical students will exercise their profession? Further studies should be conducted to answer these questions. 3. One of the problems in this article is that it was not possible to evaluate the severity and the degree of depression and the onset of manic-depressive psychosis could not be distinguished from a simple transient depressive reaction. References [1] JAMA 2003;289:3095—3105. [2] J Psychiatr Res 2013;47:391—400.
Willcutts KF, Chung MC, Erenberg CL, Finn KL, Schirmer BD, Byham-Gray LD. Early oral feeding as compared with traditional timing of oral feeding after upper gastrointestinal surgery: a systematic review and meta-analysis. Ann Surg 2016;264:54—63. http://dx.doi.org/10.1097/SLA.0000000000001644
Objective To compare the effects of early oral feeding to traditional (or late) timing of oral feeding after upper gastrointestinal surgery on clinical outcomes. Background Early postoperative oral feeding is becoming more common, particularly as part of multimodal or fast-track protocols. However, concerns remain about the safety of early oral feeding after upper gastrointestinal surgery. Methods Comprehensive literature searches were conducted across 5 databases from January 1980 until June 2015 without language restriction. Risk of bias of included studies was appraised and random-effects model meta-analyses were performed to synthesize outcomes of anastomotic leaks, pneumonia, nasogastric tube reinsertion, reoperation, readmissions, and mortality. Results Fifteen studies comprising 2112 adult patients met all the inclusion criteria. Mean hospital stay was significantly shorter in the early-fed group than in the late-fed group (weighted mean difference = −1.72 d, 95% confidence interval [CI]: −1.25 to −2.20, P < 0.01). Postoperative length of stay was also significantly shorter (weighted mean difference = −1.44 d, 95% CI: −0.68 to −2.20, P < 0.01). There was no significant difference in risk of anastomotic leak, pneumonia, nasogastric tube reinsertion, reoperation, readmission, or mortality in the randomized controlled trials (RCTs). The pooled RCT and non-RCT results, however, showed a significantly lower risk of pneumonia in early-fed as compared with late-fed group (odds ratio = 0.6, 95% CI: 0.41—0.89, P = 0.01). Conclusions
291 Early postoperative oral feeding as compared with traditional (or late) timing is associated with shorter hospital length of stay and is not associated with an increase in clinically relevant complications. Comments 1. Whereas the traditional goal of postoperative fasting with insertion of a nasogastric tube was to protect the gastrointestinal suture lines and decrease the risk of postoperative complications, this meta-analysis topples a long-standing dogma (i.e. postoperative fasting is necessary), and even suggests that early feeding within the first 24 h might decrease postoperative complications. 2. One positive point of this meta-analysis is that it included only studies that dealt with postoperative oral feeding and not those dealing with early enteral feeding with a jejunostomy or nasojejunal tube. 3. However, as in all meta-analyses, several methodological biases limit the transposition of results into daily practice: (i) randomized trials were mixed with nonrandomized trials, (ii) indications for and types of surgery performed were different (the probability of pulmonary aspiration being completely different after esophagectomy vs. pancreatectomy), (iii) absence of gradation of severity, and lack of standardization in the definition of complications, (iv) absence of blinding in these studies, leading to a potential bias in the evaluation of complications, i.e. under-estimation of the incidence of complications in the ‘‘modern’’ arm, (v) absence of precision concerning the modalities of postoperative feeding (fluids?, solids?, progression in the introduction of solids), (vi) imbalance between the percentage of gastrectomies (52%) and esophagectomies that represented only 11% of the population while hepato-biliary surgery was performed in 25% and above all, (vii) absence of data concerning the clinical situations that obviously did not influence the indications of early postoperative oral feeding, as for example, the high risk of aspiration after esophagectomy when the patient had vocal cord paralysis.
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Thromboprophylaxie après chirurgie bariatrique : pour quels patients ? Aminian A, Andalib A, Khorgami Z, et al. Who Should get extended thromboprophylaxis after bariatric surgery? A risk assessment tool to guide indications for post-discharge pharmacoprophylaxis. Ann Surg 2017;265:143—150. http://dx.doi.org/10.1097/SLA.0000000000001686
Objective To determine the risk factors for 30-day post-discharge venous thromboembolism (VTE) after bariatric surgery and to identify potential indications for extended pharmacoprophylaxis. Background VTE is among most common causes of death after bariatric surgery. Most VTEs occur after hospital stay; still a few patients receive extended pharmacoprophylaxis postdischarge. Methods From American College of Surgeons-National Surgical Quality Improvement Program, we identified 91,963 patients, who underwent elective primary and revisional bariatric surgery between 2007 and 2012. Regression-based techniques were used to create a risk assessment tool to
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predict risk of post-discharge VTE. The model was validated using the 2013 American College of Surgeons-National Surgical Quality Improvement Program dataset (n = 20,575). Significant risk factors were used to create a user-friendly online risk calculator. Results The overall 30-day incidence of post-discharge VTE was 0.29% (n = 269). In those experiencing a post-discharge VTE, mortality increased about 28-fold (2.60% vs. 0.09%; P < 0.001). Among 45 examined variables, the final riskassessment model contained 10 categorical variables including congestive heart failure, paraplegia, reoperation, dyspnea at rest, nongastric band surgery, age ≥ 60 years, male sex, BMI ≥ 50 kg/m, postoperative hospital stay ≥ 3 days, and operative time ≥ 3 hours. The model demonstrated good calibration (Hosmer-Lemeshow goodness-of-fit test, P = 0.71) and discrimination (c-statistic = 0.74). Nearly 2.5% of patients had a predicted post-discharge VTE risk > 1%. Conclusions More than 80% of post-bariatric surgery VTE events occurred post-discharge. Congestive heart failure, paraplegia, dyspnea at rest, and reoperation are associated with the highest risk of post-discharge VTE. Routine post-discharge pharmacoprophylaxis can be considered for high-risk patients (i.e., VTE risk > 0.4%). Comments 1. Bariatric surgery has developed in parallel to the epidemic increasing incidence of morbid obesity, with a small but non-negligible risk of complications, especially thromboembolic complications (TEC): 1 to 3% of deep venous complications and 0.3 to 2% of pulmonary embolism [1,2]. 2. This study highlights the fact that TEC are not exceptional and above all, that in 80% of cases, they occur after patient discharge, justifying prolonged mechanical and/or pharmacologic prophylaxis in patients at risk. This explains the pertinent drive of the authors to identify the mostly patient-related risk factors for TEC after bariatric surgery, in order to propose a targeted preventive approach. 3. As a comparison, thromboembolic prophylaxis is recommended for 28 days after surgery for cancer [3]. 4. The modalities of thromboembolic prophylaxis remain vague in the context of bariatric surgery, and in particular, the dosage with respect to increased body surface. 5. As is the case with all administrative data bases, a certain number of limitations have to be underscored: (i) the possibility that all TEC were not reported, (ii) absence of certain descriptive data such as contraceptive medications, antecedent history of TEC, existence of constitutional coagulation disorders (antiphospholipid syndrome, Leiden factor V. . .), existence of a central vascular line, early postoperative complications such as anastomotic fistula that increase the risk of TEC. . . References [1] Obes Surg 2003;13:819—825. [2] N Engl J Med 2009;361:445—454. [3] Thromb Res 2014;133:985—992.
Roman-Gonzalez A, Zhou S, Ayala-Ramirez M et al. Impact of surgical resection of the primary tumor on overall survival in patients with metastatic pheochromocytoma or sympathetic paraganglioma. Ann Surg 2017; Ahead of Print. http://dx.doi.org/10.1097/SLA.0000000000002195
Objective To determine whether primary tumor resection in patients with metastatic pheochromocytoma or paraganglioma (PPG) is associated with longer overall survival (OS). Background Patients with metastatic PPG have poor survival outcomes. The impact of surgical resection of the primary tumor on OS is not known. Methods We retrospectively studied patients with metastatic PPG treated at the University of Texas, MD Anderson Cancer Center from January 2000 through January 2015. Kaplan-Meier analysis with log-rank tests was used to compare OS among patients undergoing primary tumor resection and patients not treated surgically. Propensity score method was applied to adjust for selection bias using demographic, clinical, biochemical, genetic, imaging, and pathologic information. Results A total of 113 patients with metastatic PPG were identified. Eighty-nine (79%) patients had surgery and 24 (21%) patients did not. Median OS was longer in patients who had surgery than in patients who did not [148 months, 95% confidence interval (CI): 112.8—183.2 months vs. 36 months, 95% CI: 27.2—44.8 months; P < 0.001]. Fifty-three (46%) patients had synchronous metastases; of these patients, those who had surgery had longer OS than those who did not (85 months, 95% CI: 64.5—105.4 months vs. 36 months, 95% CI: 29.7—42.3 months; P < 0.001). Patients who had surgery had a similar ECOG performance status to the ones who did not (P = 0.1798, two sample t-test; P = 0.2449, Wilcoxon rank sum test). Univariate and propensity score analysis confirmed that patients treated with surgery had longer OS than those not treated surgically irrespective of age, race, primary tumor size and location, number of metastatic sites, and genetic background (log-rank P < 0.001). In patients with hormonally active tumors (70.8%), the symptoms of catecholamine excess improved after surgery. However, the tumor burden was a more important determinant of OS than hormonal secretion. Conclusions Primary tumor resection in patients with metastatic PPG appeared to be associated with improved OS. In patients with hormonally active tumors, surgical resection led to better blood pressure control. Comments 1. This study is very important because it shows for the first time that resection of the primary tumor in patients with metastatic pheochromocytoma impacts overall survival favorably. These data should lead to modification of the current management of these tumors. This strategy of primary tumor resection has been validated for small intestinal endocrine tumors and is under discussion for pancreatic endocrine tumors [1]. 2. The number of patients included is impressive for this rare type of tumor. As the duration of inclusion was 15 years, the group can be considered chronologically homogeneous and gives some weight to the conclusions [2]. 3. Interestingly, the type of resection of the primitive tumor (R0, R1 or R2) did not impact overall survival. Therefore tumor mass reduction is more important as a determinant factor for survival than the completeness of the procedure. 4. Because of the small number of patients, this study cannot answer the question of whether to incorporate one or several procedures for resection of metastases at the same time as surgery on the primary tumor.
Press review References [1] Surgery 2014;155:607—14. [2] Ann Surg 2016;263:582—7.
Watson AJ, Hudson J, Wood J et al. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial. Lancet 2016;388:2375—2385. http://dx.doi.org/10.1016/S0140-6736(16)31803-7
Background Two commonly performed surgical interventions are available for severe (grade II—IV) hemorrhoids; traditional excisional surgery and stapled hemorrhoidopexy. Uncertainty exists as to which is most effective. The eTHoS trial was designed to establish the clinical effectiveness and costeffectiveness of stapled hemorrhoidopexy compared with traditional excisional surgery. Methods The eTHoS trial was a large, open-label, multicenter, parallel-group, pragmatic randomized controlled trial done in adult participants (aged 18 years or older) referred to hospital for surgical treatment for grade II—IV hemorrhoids. Participants were randomly assigned (1:1) to receive either traditional excisional surgery or stapled hemorrhoidopexy. Randomization was minimized according to baseline EuroQol 5 dimensions 3 level score (EQ-5D-3L), hemorrhoid grade, sex, and center with an automated system to stapled hemorrhoidopexy or traditional excisional surgery. The primary outcome was area under the quality of life curve (AUC) measured with the EQ-5D-3L descriptive system over 24 months, assessed according to the randomized groups. The primary outcome measure was analyzed using linear regression with adjustment for the minimization variables. This trial is registered with the ISRCTN registry, number ISRCTN80061723. Findings Between Jan 13, 2011, and Aug 1, 2014, 777 patients were randomized (389 to receive stapled hemorrhoidopexy and 388 to receive traditional excisional surgery). Stapled hemorrhoidopexy was less painful than traditional excisional surgery in the short term and surgical complication rates were similar between groups. The EQ-5D-3L AUC score was higher in the traditional excisional surgery group than the stapled hemorrhoidopexy group over 24 months; mean difference −0.073 (95% CI: −0.140 to −0.006; P = 0.0342). EQ-5D-3L was higher for stapled hemorrhoidopexy in the first 6 weeks after surgery, the traditional excisional surgery group had significantly better quality of life scores than the stapled hemorrhoidopexy group. In total, 24 (7%) of 338 participants who received stapled hemorrhoidopexy and 33 (9%) of 352 participants who received traditional excisional surgery had serious adverse events. Interpretation As part of a tailored management plan for hemorrhoids, traditional excisional surgery should be considered over stapled hemorrhoidopexy as the surgical treatment of choice. Comments 1. With respect to the prevalence of hemorrhoid surgery that represents around 25,000 interventions per year in the English National Health System, this randomized trial is important and marks a milestone, showing that the classical Milligan and Morgan operation, assuredly more painful in the short term, is more effective in the longterm with less recurrence, better quality of life and costeffectiveness.
293 2. This trial underscores the value of rigorous evaluation in surgical innovation, in order not to ride on the wave of technological modernism if it does not provide the proof of major benefit for the patient, especially when the societal cost is higher. 3. As there was no statistically significant difference found concerning the duration of operation or hospital stay, or the percentage of patients returning to professional activity at six weeks, the stapled hemorrhoidopexy has lost some of its aura, especially when one compares the continence scores at 24 months, which are better with the traditional excisional operation of Milligan and Morgan. 4. Among the limitations, we note: absence of blinding in the evaluation and missing data in the 24-month functional outcome evaluation.
Aquina CT, Becerra AZ, Probst CP, et al. Patients with adhesive small bowel obstruction should be primarily managed by a surgical team. Ann Surg 2016;264:437—47. http://dx.doi.org/10.1097/SLA.0000000000001861
Objective To evaluate the impact of a primary medical versus surgical service on healthcare utilization and outcomes for adhesive small bowel obstruction (SBO) admissions. Summary background data Adhesive-SBO typically requires hospital admission and is associated with high healthcare utilization and costs. Given that most patients are managed nonoperatively, many patients are admitted to medical hospitalists. However, comparisons of outcomes between primary medical and surgical services have been limited to small single-institution studies. Methods Unscheduled adhesive-SBO admissions in NY State from 2002 to 2013 were identified using the Statewide Planning and Research Cooperative System. Bivariate and mixedeffects regression analyses were performed assessing factors associated with healthcare utilization and outcomes for SBO admissions. Results Among 107,603 admissions for adhesive-SBO (78% nonoperative, 22% operative), 43% were primarily managed by a medical attending and 57% were managed by a surgical attending. After controlling for patient, physician, and hospital-level factors, management by a medical service was independently associated with longer length of stay [IRR = 1.39, 95% confidence interval (CI) = 1.24, 1.56], greater inpatient costs (IRR = 1.38, 95% = 1.21, 1.57), and a higher rate of 30-day readmission (OR = 1.32, 95% CI = 1.22, 1.42) following nonoperative management. Similarly, of those managed operatively, management by a medicine service was associated with a delay in time to surgical intervention (IRR = 1.84, 95% CI = 1.69, 2.01), extended length of stay (IRR = 1.36, 95% CI = 1.25, 1.49), greater inpatient costs (IRR = 1.38, 95% CI = 1.11, 1.71), and higher rates of 30-day mortality (OR = 1.92, 95% CI = 1.50, 2.47) and 30-day readmission (OR = 1.13, 95% CI = 0.97, 1.32). Conclusions This study suggests that management of patients presenting with adhesive-SBO by a primary medical team is associated with higher healthcare utilization and worse perioperative outcomes. Policies favoring primary management
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by a surgical service may improve outcomes and reduce costs for patients admitted with adhesive-SBO. Comments 1. While adhesive intestinal obstruction is associated with repeated hospitalizations, and costly care, this population study suggests that primary management by a surgical team and early surgery (versus conservative medical treatment) provides better outcomes and reduces costs of care. 2. This study, the largest to date, and the first populationbased study, confirms the results of other studies with samples ranging from 65 to 635 cases, i.e. that early surgery is better [1—4]. 3. As is the case with other administrative data base studies, there are limitations such as absence of variables such as vital signs upon admission, antecedent medical and surgical history, data concerning the clinical and biological investigations as well as the quality of coding. 4. Likewise, it would have been useful to know the criteria used to choose one or another treatment from the patient’s and the attending physician’s viewpoint. References [1] Ann Surg 2001;67:1034—1038. [2] Surgery 2001;130:706—711. [3] Am Surg 2010;76:687—691. [4] J Am Coll Surg 2015;221:7—13.
Lazzati A, De Antonio M, Paolino L, et al. Natural history of adjustable gastric banding: lifespan and revisional rate: a nationwide study on administrative data on 53,000 patients. Ann Surg 2017;265:439—445. http://dx.doi.org/10.1097/SLA.0000000000001879
Objective The aim of this study was to analyze the adjustable gastric banding (AGB) natural history on a national basis. Background Adjustable gastric banding represented the most common bariatric procedure in France until 2010. Since then, the number of AGBs has decreased and the rate of band removal and revisional surgeries has progressively increased. Methods For analysis, we included all adult patients operated on with AGB in France between 2007 and 2013. Data were extracted from a national administrative database (‘‘Programme de médicalisation des systèmes
d’information’’ [PMSI]), which is an exhaustive source of all surgical procedures performed in France. The Cox proportional hazard model was used to test univariate and multivariate associations with band survival and revisional rate. To control for center-specific effects, we performed a frailty analysis, in which each center was assumed to have a random effect indicating the possibility of different baseline risks for patients at different centers. Results During the study period, 52,868 patients underwent AGB, and 10,815 bands were removed. The removal rate at 5, 6, and 7 years was 28%, 34%, and 40%, respectively. Female sex, body mass index > 50 kg/m, type 2 diabetes, hypertension, dyslipidemia, and sleep apnea were found to be significantly associated with band removal by multivariate analysis. A significant center effect was also found, but this did not change the impact of the highly significant factors already identified. After band removal, the median time to revisional surgery was 1 year (95% confidence interval: 1.0—1.1) and the conversion rate at 7 years was 71%. Conclusions With a removal rate of about 6% annually and the need for revisional surgery for more than two-thirds of patients after removal, AGB does not appear to provide a long-term solution for obesity. Comments 1. This high-quality population-based study consolidates the clinical impression and the results of other small sample studies [1,2], that is, that adjustable gastric banding (AGB) is associated with high rates of band removal and revisional surgery and opens the door for other procedures to treat morbid obesity. 2. Of note, the authors used the ablation rate as their main endpoint, while excess weight loss and/or resolution of co-morbidity are the most widely used dependent variables. 3. The main limitation of this study is the absence of information as to the cause for band removal. References [1] Obes Surg 2004;14:1343—1348. [2] Arch Surg 2011;146:802—807.
Disclosure of interest The authors declare that they have no competing interest.