- Email: [email protected]
Optimization of an early discharge program after laparoscopic radical prostatectomy
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Actas Urol Esp. 2014;xxx(xx):xxx---xxx
Actas Urológicas Españolas www.elsevier.es/actasuro
ORIGINAL ARTICLE
Optimization of an early discharge program after laparoscopic radical prostatectomy夽 F.J. Díaz a,∗ , E. de la Pe˜ na a , V. Hernández a , B. López a , J.M. de La Morena a , M.D. Martín b , I. Jiménez-Valladolid a , C. Llorente a a b
Servicio de Urología, Hospital Universitario Fundación Alcorcón, Madrid, Spain Servicio de Medicina Preventiva, Hospital Universitario Fundación Alcorcón, Madrid, Spain
Received 31 August 2013; accepted 14 December 2013
KEYWORDS Prostatic neoplasia; Prostatectomy; Laparoscopy; Length of stay; Conditional variables; Patient discharge
Abstract Objective: To assess the safety of hospital discharge 24 h after laparoscopic radical prostatectomy and to identify possible factors associated with longer hospital stays. Materials and methods: Retrospective study of patients diagnosed with localized prostate cancer who underwent laparoscopic radical prostatectomy consecutively between May 2007 and December 2010. Those patients who met the following requirements were discharged in less than 24 h: absence of complications, drainage debit minor than 50 cc, normal oral tolerance, no significant bladder haematuria and good functional recovery. Logistic regression analysis was conducted in order to assess the possible associated variables with longer hospital stays. Results: A total of 266 patients were analyzed. The follow-up median was 34 months. Eighty patients (30.1%) were discharged in less than 24 h. Average stay (SD) of all series was 2.9 days (3.08). Solely HTA, neurovascular bundles sparing and the development of lymphadenectomy were statistically significant between both groups in univariate analysis (discharge <24 h vs. discharge >24 h). In multivariate analysis, only HTA (OR = 1.98 [CI 95%: 1.13---3.47], P = .016) and lymphadenectomy performance (OR = 2.56 [CI 95%: 1.18---5.56] P = .017) were independent predictive variables of hospital stays longer than 24 h. Conclusions: Early hospital discharge of patients who underwent LRP is feasible and safe. In our series, the lymphadenectomy performance and the HTA were associated factors for longer hospital stay. © 2013 AEU. Published by Elsevier España, S.L. All rights reserved.
夽 Please cite this article as: Díaz F, de la Pe˜ na E, Hernández V, López B, de La Morena J, Martín M, et al. Optimización de un programa de alta precoz tras prostatectomía radical laparoscópica. Actas Urol Esp. 2014. http://dx.doi.org/10.1016/j.acuro.2013.12.004 ∗ Corresponding author. E-mail address: [email protected] (F.J. Díaz).
2173-5786/$ – see front matter © 2013 AEU. Published by Elsevier España, S.L. All rights reserved.
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PALABRAS CLAVE Neoplasia prostática; Prostatectomía; Laparoscopia; Duración de la estancia; Variables condicionales; Alta del paciente
Optimización de un programa de alta precoz tras prostatectomía radical laparoscópica Resumen Objetivo: Evaluar la seguridad del alta hospitalaria a las 24 h tras prostatectomía radical laparoscópica y determinar posibles factores asociados con estancias hospitalarias más prolongadas. Material y métodos: Estudio retrospectivo de pacientes con diagnóstico clínico de cáncer de próstata localizado, intervenidos consecutivamente entre mayo de 2007 y diciembre de 2010 mediante prostatectomía radical laparoscópica. Los pacientes fueron dados de alta en menos de 24 h en el caso de cumplir los siguientes requisitos: ausencia de complicaciones médicas, débito del drenaje menor de 50 cc, tolerancia oral normal, no hematuria significativa por sonda vesical y buena recuperación funcional del paciente. Realizamos un análisis de regresión logística para evaluar las posibles variables asociadas con ingreso mayor de 24 h. Resultados: Se analizaron un total de 266 pacientes. La mediana de seguimiento fue de 34 meses. Ochenta (30,1%) pacientes fueron dados de alta en menos de 24 h. La estancia media (DE) de la serie global fue de 2,9 días (3,08). En el análisis univariado solo las variables HTA, preservación de haces neurovasculares y la realización de linfadenectomía resultaron estadísticamente diferentes entre ambos grupos (alta < 24 h vs. alta > 24 h). En el análisis multivariado solo la HTA con OR de 1,98 (IC 95%: 1,13-3,47) p = 0,016 y la realización de linfadenectomía con OR de 2,56 (IC 95%: 1,18-5,56) p = 0,017 resultaron ser variables predictivas independientes para estancias hospitalarias mayores de 24 h. Conclusiones: El alta temprana de los pacientes intervenidos mediante PRL es factible y seguro. En nuestra serie la realización de linfadenectomía y la HTA fueron factores asociados a una estancia hospitalaria más prolongada. © 2013 AEU. Publicado por Elsevier España, S.L. Todos los derechos reservados.
Introduction Radical prostatectomy remains the standard surgical treatment for patients with clinically localized prostate cancer. The benefits of laparoscopic surgery as a minimally invasive technique have been well documented in different published series, being accepted as an alternative to open surgery in the treatment of localized prostate cancer,1 and maintaining, to say the least, equivalent oncological and functional results.2---5 Minimally invasive surgery has shown multiple advantages in comparison with open surgery, such as a lower rate of blood transfusion, less postoperative pain, and a shorter hospital stay,6---8 which allows for the development of an early post-surgical discharge program. To this end, it is necessary to identify those factors which may predict its actual application using criteria of maximum effectiveness and safety. Our aim was to assess the safety of hospital discharge 24 h after laparoscopic radical prostatectomy (LRP), as well as to identify possible factors associated with longer hospital stays, in order to select the most suitable patients for early discharge and to improve these factors if possible.
Methods A total of 266 patients who had consecutively undergone extraperitoneal LRP between May 2007 and December 2010 were analyzed. All the patients had a clinical diagnosis of localized prostate cancer except for a patient with clinical stage cT3. The characteristics of the patients, including their demographic profile, their clinical features, anatomopathological data, and 90-day postoperative complications classified
according to the Clavien system9 were prospectively collected in our institutional database. All procedures were performed by 2 surgeons with a previous experience of 5 years in this kind of surgical technique. The surgical approach was extraperitoneal in all cases. Continuous suture was performed for urethrovesical anastomosis, whilst checking its tightness in an intraoperative manner. All patients were hospitalized on the same day of surgery and received prophylactic antibiotics with a dose of secondgeneration cephalosporin. Antithrombotic prophylaxis with low-molecular-weight heparin began on the first postoperative day in the absence of bleeding and was maintained for 3 weeks after hospital discharge. Anticoagulation in patients treated with dicoumarinics was reversed through an outpatient procedure. Limited ilio-obturator lymphadenectomy was performed in intermediate- and high-risk patients, according to the D’Amico classification.10 It should be mentioned that over the last 2 years (which were not included in this study) we have been performing extended lymphadenectomy in high-risk patients, thus replacing in such cases our customary extraperitoneal approach with a transperitoneal one, facilitating the exposure of the fundamental anatomical structures for the performance of this technique. All patients left the operating room with a type-B analgesic protocol consisting of paracetamol 1 g IV every 8 h alternating with metamizole 2 g IV every 8 h, adding dexketoprofen 50 mg IV as rescue analgesic if necessary. Preservation of neurovascular bundles was done in an extrafascial way in patients with adequate preoperative erectile function and low-risk tumor characteristics.
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Optimization of an early discharge program after laparoscopic radical prostatectomy Patients were discharged in less than 24 h only if they met the following requirements: absence of medical complications, drain output of less than 50 cc --- the latter being removed before discharge ---, normal oral tolerance, absence of significant hematuria by bladder catheter, and good functional recovery of the patient. All patients were discharged with a bladder catheter which was removed 10 days after surgery at our clinics. No cystourethrography was routinely performed prior to catheter removal. Patients were directly discharged to their home under the care of a family member, who had been given the necessary instructions by the nursing staff during their admission.
Statistical analysis Measurable variables are expressed as mean (standard deviation [SD]) or as median (interquartile range [IQR]). Quantitative variables were compared using Student’s ‘‘t’’ test or non-parametric tests after assessing the distribution of the variable (Kolmogorov---Smirnov). Qualitative variables are expressed as ratios and were compared using Pearson’s chi-square test with continuity correction or Fisher’s exact test, as appropriate. A logistic regression analysis was performed to evaluate the possible variables associated with a longer postoperative hospital stay (longer than 24 h). The significance level of all hypothesis-testing procedures was 0.05. The statistical analysis was carried out using SPSS 15.0 Statistical Package for Windows (SPSS Inc, Chicago, IL).
Results A total of 266 patients who underwent LRP were analyzed with a median follow-up of 34 months (9.5---53). The clinical and pathological characteristics of these patients are shown in Table 1. One hundred and sixty-nine (63.5%) patients were discharged within 48 h, 80 (30.1%) of whom where discharged after a hospital stay of less than 24 h, and meeting the inclusion criteria for early discharge described above. The mean hospital stay (SD) of the overall series was 2.9 days (3.08). Tolerance started early (≤8 h) in 243 patients (91.4%). Thirty-one patients (11.7%) experienced post-surgical complications which where divided according to the modified Clavien scale (Table 2). Six (2.2%) of these complications corresponded to the 24-h discharge group (4 of them were classified as Clavien I and 2 as Clavien II). Eighteen (6.8%) patients had to attend the Emergency Services due to these complications. Of the group of patients who were discharged within 24 h only one was readmitted due to hematuria. Of the 97 patients with a hospital stay longer than 48 h, 17 overstayed due to clinically relevant complications, which are included in Table 2. In the 80 remaining patients, the causes, in order of frequency, leading to a hospital stay exceeding 48 h were the following: long-term lymphorrhea output due to drainage (50), mild hematuria with no clinical and/or analytical impact,11 hemodynamically significant
Table 1
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Global series.
Variables
N (%) a
Age, years Charlson comorbidity scale (≥ 2) ASA I II III Previous abdominal surgery Total PSA, ng/mlb Prostate volume, mlb
64.3 (6.24) 84 (31.6) 18 (6.8) 142 (53.4) 101 (38) 78 (29.3) 6.4 (4.5) 33.5 (20.7)
Clinical stage T1c T2 T3
222 (83.5) 43 (16.1) 1 (0.4)
Biopsy Gleason ≤6 7 8---10
159 (59.7) 76 (28.6) 31 (11.7)
Mean surgical timea Bilateral lymphadenectomy Neurovascular bundle sparing a b
201.3 (32.1) 59 (22.2) 39 (14.7)
Data expressed as mean (SD). Data expressed as median (IQR).
Table 2 Postoperative complications classified according to modified Clavien. Complications
N (%)
Clavien I: Any deviation from a normal 18 (6.7) postoperative course, without the need for pharmacological, radiological, endoscopic, or surgical therapy. Treatments like antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy are allowed Clavien II: Complications requiring 7 (2.6) pharmacological treatment with drugs other than those allowed for grade I complications, also including the need for blood transfusion or parenteral nutrition Clavien III: Clavien II: Complications requiring surgical, endoscopic, or radiological complications: (a) Intervention without need for general anesthesia (b) Intervention under general anesthesia Clavien IV: Complications involving life risk for the patient and requiring intensive care management (including complications of the central nervous system): (a) Single-organ failure (b) Multi-organ failure Clavien V: Death
5 (1.8)
1 (0.3)
0 (0)
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F.J. Díaz et al. Table 3
Univariate analysis of pre and postoperative variables (prediction of hospital stay).
Variable a
Age, years Charlson comorbidity scale (≥ 2) HBP Coronary artery disease Hypercholesterolemia Diabetes mellitus COPD
≤24 h; n (%)
>24 h; n (%)
p
63.9 28 28 3 23 16 13
64.4 56 95 17 52 26 19
0.49 0.23 0.01 0.09 0.50 0.15 0.12
(6.1) (35) (35) (3.8) (28.8) (20) (16.3)
(6.2) (30.1) (51.4) (9.2) (28.1) (14) (10.3)
0.69
ASA I II III
4 (5.2) 41 (53.2) 32 (41.6)
14 (7.6) 101 (54.9) 69 (37.5)
26 (32.5) 5.4 (3.2) 33 (25)
52 (28.1) 6.7 (5.2) 33.7 (19.3)
Clinical stage T1c T2 T3
69 (86.3) 11 (13.7) 0 (0)
153 (82.7) 32 (16.8) 1 (0.5)
Gleason of the biopsy ≤6 7 8---10
50 (62.5) 22 (27.5) 8 (10)
109 (58.6) 54 (29) 23 (12.4)
Mean surgical time (min)a Lymphadenectomy Neurovascular bundle sparing
199.61 (33.8) 9 (11.5) 18 (22.5)
202.14 (31.4) 50 (26.9) 21 (11)
Previous abdominal surgery Total PSA ng/dlb Prostate volume (ml)b
a b
0.28 0.08 0.97 0.65
0.44
0.60 0.006 0.01
Data expressed as mean (SD). Data expressed as median (range).
orthostatic dizziness,5 social or family situation of dependency and/or isolation,7 weekend discharges4 and low-grade fever not higher than 37.5 ◦ C.3 In the univariate analysis (Table 3) only the HTN, neurovascular bundle preservation and the performance of lymphadenectomy variables, were statistically different between both the groups (high < 24 h vs. high > 24 h). However, in the multivariate analysis (Table 4), once adjusted by the different variables, only the HTN variable with an OR of 1.98 (CI 95%: 1.13---3.47 [p = 0.016]) and the performance of lymphadenectomy with an OR of 2.56 (CI 95%: 1.18---5.56 [p = 0.017]) proved to be variables independently associated with hospital stays longer than 24 h. We propose a possible association between bundle preservation and the 2 variables which proved to be significantly associated with longer hospital stays; therefore, we carried out a chi-square test to evaluate such a possible association, objectifying a statistically significant difference among the preserved patients vs. the non-preserved ones
Table 4
regarding the performance of lymphadenectomy (5.3 vs. 22.2%; p = 0.006) and HTN (29 vs. 49.6%; p = 0.014).
Discussion Laparoscopic extraperitoneal radical prostatectomy has become the standard treatment for the management of localized prostate cancer at our center.11 Throughout our more than 10 years experience we have seen that patients achieve a rapid and safe postoperative convalescence. This has encouraged us to implement the 24-h discharge program. Our series showed the suitability of an early hospital discharge program, without an increase in postoperative complications, being adapted to the requirements and needs of our patients today, as well as to the current socioeconomic context. Despite the numerous modifications regarding the original technique and the greater experience of surgeons, open
Multivariate analysis.
Variable
OR
CI
p
HBP Lymphadenectomy
1.98 2.56
1.13---3.47 1.18---5.56
0.016 0.017
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Optimization of an early discharge program after laparoscopic radical prostatectomy radical prostatectomy still has inherent morbidity associated with it. In 1985 the mean stay of patients who underwent RP was longer than 2 weeks, with a mean time of 15 days for the perineal approach and 19 days for the retropubic approach.12 Since 1993, with a better understanding of surgery, as well as the introduction of significant improvements in the surgical technique and the anesthetic field, several groups have published mean hospital stays of around 5 days.13---15 This length of stay has steadily decreased even to 24 h in some centers, thanks to major technical developments such as the introduction of the laparoscopic approach and the recent introduction of robotic surgery,16 as well as the introduction of changes in conduct and postoperative care.17 Minimally invasive surgery offers potential advantages when compared with the classical open approach,18 one of them being a decrease in hospital stay, as it has already been shown in several published series.19---21 In order to implement an early discharge program at our center, we do not only need our efforts, but also to work in coordinated and close cooperation with the anesthesia department (avoiding long bed stays of patients) and with the nursing department (starting oral tolerance and moving the patient on the same day of surgery). According to the results of other published series, the laparoscopic approach has enabled us to reduce significantly the postoperative morbidity of our patients, with a lower transfusion rate, less need for analgesia, and fewer surgical wound complications.6---8,22 Ileus and abdominal distension have been seen in some patients of series 2 as the most common complications in patients who underwent LRP, thus extending the hospital stay.23,24 Aspects such as dietary management and postoperative analgesia are important when trying to reduce their incidence. Besides, as shown in the case of kidney surgery, the extraperitoneal approach may help prevent this possible paralytic ileus, probably caused in some cases by the presence of blood and/or carbonic acid in the intraperitoneal cavity.25 It should be mentioned, however, that this kind of laparoscopic approach (intraperitoneal or extraperitoneal) for radical surgery of the prostate remains an issue of discussion regarding its possible advantages and complications. While Eden et al.26 found differences with regard to operative time, hospitalization, and early continence in favor of the extraperitoneal approach, Erdogru et al.,27 in their comparative study, did not show statistically significant differences between both approaches. It is of remarkable interest to know whether there are also preoperative factors which may facilitate the selection of patients to whom this early discharge program can be safely applied, as well as to identify and modify those factors which may enable us to expand the group of patients to whom that program can be applied. Novara et al.28 identified the surgeon’s experience and prostate volume as predictors of possible postsurgical complications. Hruza et al.29 found the surgical time < 4 h, neurovascular bundle preservation, and the technique of anastomotic suture (by means of interrupted sutures) as predictors of postoperative complication. In our series, lymphadenectomy was introduced as a predictor associated with increased hospital stay. This fact is
5
clinically linked to prolonged drainage debit, first factor related to stays > 48 h. HTN was also significantly associated with that longer stay. No clinical explanation was found to justify a longer hospital stay in the case of hypertensive patients. All patients showed normal tension levels during their hospital stay. In any case, and despite the clarifications and instructions given to the patient and their families prior to surgery, there is always an emotional factor in each patient (anxiety, concern for possible complications, insecurity) which, in the event of clinically non-relevant disorders (mild hematuria, orthostatic dizziness, low-grade fever), in a normal postoperative course, may compromise the feasibility of early discharge from a medical point of view, since it may be construed as a hurried discharge by the patient. On the other hand, it should be emphasized that, occasionally, structural and administrative constraints (nonexecuted discharges over the weekend/on public holidays with no physician present at the hospital, as in our case) may extend that stay with no clinical cause rendering it necessary. The most important limitations in our study were its retrospective nature, as well as the lack of an objective analysis evaluating the more than likely economic impact caused by earlier hospital discharge. Further prospective studies are required to confirm this fact and to analyze the most important risk factors for longer hospital stays.
Conclusions Early discharge in patients who underwent LRP is feasible and safe, and it can be performed within 24 h in a significant percentage of patients. In our series the performance of lymphadenectomy and HTN were factors associated with a longer hospital stay. Detailed information about prognosis and postoperative home care, previous training, the standardization of the procedure and multidisciplinary collaboration are the key to success in this kind of program.
Conflict of interest The authors declare that they have no conflict of interest.
References 1. Rassweiler J, Hruza M, Teber D, Su LM. Laparoscopic and robotic assisted radical prostatectomy --- critical analysis of the results. Eur Urol. 2006;49:612---24. 2. Salomon L, Levrel O, de la Taille A, Anastasiadis AG, Saint F, Zaki S, et al. Radical prostatectomy by the retropubic, perineal and laparoscopic approach: 12 years of experience in one center. Eur Urol. 2002;42:104---10. 3. Rassweiler J, Schulze M, Teber D, Marrero R, Seemann O, Rumpelt J, et al. Laparoscopic radical prostatectomy with the Heilbronn technique: oncological results in the first 500 patients. J Urol. 2005;173:761---4. 4. Guillonneau B, El fettouh H, Baumert H, Cathelineau X, Doublet JD, Fromont G, et al. Laparoscopic radical prostatectomy:
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17. Koch MO, Smith Jr JA. Clinical outcomes associated with the implementation of a cost-efficient programme for radical retropubic prostatectomy. Br J Urol. 1995;76:28---33. 18. Smith Jr JA. Robotically assisted laparoscopic prostatectomy: an assessment of its contemporary role in the surgical management of localized prostate cancer. Am J Surg. 2004;188 4A Suppl.:63S---7S. 19. Menon M, Tewari A, Peabody J, VIP Team. Vattikuti Institute prostatectomy: technique. J Urol. 2003;169:2289---92. 20. Lotan Y, Cadeddu JA, Gettman MT. The new economics of radical prostatectomy: cost comparison of open, laparoscopic and robot assisted techniques. J Urol. 2004;172 4 Pt 1:1431---5. 21. Menon M. Robotic radical retropubic prostatectomy. BJU Int. 2003;91:175---6. 22. Hu JC, Gu X, Lipsitz SR, Barry MJ, D’Amico AV, Weinberg AC, et al. Comparative effectiveness of minimally invasive vs open radical prostatectomy. JAMA. 2009;302:1557---64. 23. Nelson B, Kaufman M, Broughton G, Cookson MS, Chang SS, Harrel SD, et al. Comparison of length of hospital stay between radical retropubic prostatectomy and robotic assisted laparoscopic prostatectomy. J Urol. 2007;177:929---31. 24. Koch MO, Smith JA, Hodge EM, Brandell RA. Prospective developmentof a cost-efficient program for radical retropubic prostatectomy. Urology. 1994;44:311. 25. Rassweiler J, Frede T, Henkel TO, Stock C, Alken P. Nephrectomy: a comparative study between the transperitoneal and retroperitoneal laparoscopic versus the open approach. Eur Urol. 1998;33:489---96. 26. Eden CG, King D, Kooiman GC, Adams TH, Sullivan ME, Vass JA. Transperitoneal or extraperitoneal laparoscopic radical prostatectomy: does the approach matter? J Urol. 2004;172:2218---23. 27. Erdogru T, Teber D, Frede T, Marrero R, Hammady A, Seemann O, et al. Comparison of transperitoneal and extraperitoneal laparoscopic radical prostatectomy using match-pair analysis. Eur Urol. 2004;46:312---20. 28. Novara G, Ficarra V, D’Elia C, Secco S, Cavalleri S, Artibani W. Prospective evaluation with standardised criteria for postoperative complications after robotic-assisted laparoscopic radical prostatectomy. Eur Urol. 2010;57:363---70. 29. Hruza M, Weiss HO, Pini G, Goezen AS, Schulze M, Teber D, et al. Complications in 2,200 consecutive laparoscopic radical prostatectomies: standardised evaluation and analysis of learning curves. Eur Urol. 2010;58:733---41.
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Actas Urol Esp. 2014;xxx(xx):xxx---xxx
Actas Urológicas Españolas www.elsevier.es/actasuro
ORIGINAL ARTICLE
Optimization of an early discharge program after laparoscopic radical prostatectomy夽 F.J. Díaz a,∗ , E. de la Pe˜ na a , V. Hernández a , B. López a , J.M. de La Morena a , M.D. Martín b , I. Jiménez-Valladolid a , C. Llorente a a b
Servicio de Urología, Hospital Universitario Fundación Alcorcón, Madrid, Spain Servicio de Medicina Preventiva, Hospital Universitario Fundación Alcorcón, Madrid, Spain
Received 31 August 2013; accepted 14 December 2013
KEYWORDS Prostatic neoplasia; Prostatectomy; Laparoscopy; Length of stay; Conditional variables; Patient discharge
Abstract Objective: To assess the safety of hospital discharge 24 h after laparoscopic radical prostatectomy and to identify possible factors associated with longer hospital stays. Materials and methods: Retrospective study of patients diagnosed with localized prostate cancer who underwent laparoscopic radical prostatectomy consecutively between May 2007 and December 2010. Those patients who met the following requirements were discharged in less than 24 h: absence of complications, drainage debit minor than 50 cc, normal oral tolerance, no significant bladder haematuria and good functional recovery. Logistic regression analysis was conducted in order to assess the possible associated variables with longer hospital stays. Results: A total of 266 patients were analyzed. The follow-up median was 34 months. Eighty patients (30.1%) were discharged in less than 24 h. Average stay (SD) of all series was 2.9 days (3.08). Solely HTA, neurovascular bundles sparing and the development of lymphadenectomy were statistically significant between both groups in univariate analysis (discharge <24 h vs. discharge >24 h). In multivariate analysis, only HTA (OR = 1.98 [CI 95%: 1.13---3.47], P = .016) and lymphadenectomy performance (OR = 2.56 [CI 95%: 1.18---5.56] P = .017) were independent predictive variables of hospital stays longer than 24 h. Conclusions: Early hospital discharge of patients who underwent LRP is feasible and safe. In our series, the lymphadenectomy performance and the HTA were associated factors for longer hospital stay. © 2013 AEU. Published by Elsevier España, S.L. All rights reserved.
夽 Please cite this article as: Díaz F, de la Pe˜ na E, Hernández V, López B, de La Morena J, Martín M, et al. Optimización de un programa de alta precoz tras prostatectomía radical laparoscópica. Actas Urol Esp. 2014. http://dx.doi.org/10.1016/j.acuro.2013.12.004 ∗ Corresponding author. E-mail address: [email protected] (F.J. Díaz).
2173-5786/$ – see front matter © 2013 AEU. Published by Elsevier España, S.L. All rights reserved.
ACUROE-613; No. of Pages 6
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F.J. Díaz et al.
PALABRAS CLAVE Neoplasia prostática; Prostatectomía; Laparoscopia; Duración de la estancia; Variables condicionales; Alta del paciente
Optimización de un programa de alta precoz tras prostatectomía radical laparoscópica Resumen Objetivo: Evaluar la seguridad del alta hospitalaria a las 24 h tras prostatectomía radical laparoscópica y determinar posibles factores asociados con estancias hospitalarias más prolongadas. Material y métodos: Estudio retrospectivo de pacientes con diagnóstico clínico de cáncer de próstata localizado, intervenidos consecutivamente entre mayo de 2007 y diciembre de 2010 mediante prostatectomía radical laparoscópica. Los pacientes fueron dados de alta en menos de 24 h en el caso de cumplir los siguientes requisitos: ausencia de complicaciones médicas, débito del drenaje menor de 50 cc, tolerancia oral normal, no hematuria significativa por sonda vesical y buena recuperación funcional del paciente. Realizamos un análisis de regresión logística para evaluar las posibles variables asociadas con ingreso mayor de 24 h. Resultados: Se analizaron un total de 266 pacientes. La mediana de seguimiento fue de 34 meses. Ochenta (30,1%) pacientes fueron dados de alta en menos de 24 h. La estancia media (DE) de la serie global fue de 2,9 días (3,08). En el análisis univariado solo las variables HTA, preservación de haces neurovasculares y la realización de linfadenectomía resultaron estadísticamente diferentes entre ambos grupos (alta < 24 h vs. alta > 24 h). En el análisis multivariado solo la HTA con OR de 1,98 (IC 95%: 1,13-3,47) p = 0,016 y la realización de linfadenectomía con OR de 2,56 (IC 95%: 1,18-5,56) p = 0,017 resultaron ser variables predictivas independientes para estancias hospitalarias mayores de 24 h. Conclusiones: El alta temprana de los pacientes intervenidos mediante PRL es factible y seguro. En nuestra serie la realización de linfadenectomía y la HTA fueron factores asociados a una estancia hospitalaria más prolongada. © 2013 AEU. Publicado por Elsevier España, S.L. Todos los derechos reservados.
Introduction Radical prostatectomy remains the standard surgical treatment for patients with clinically localized prostate cancer. The benefits of laparoscopic surgery as a minimally invasive technique have been well documented in different published series, being accepted as an alternative to open surgery in the treatment of localized prostate cancer,1 and maintaining, to say the least, equivalent oncological and functional results.2---5 Minimally invasive surgery has shown multiple advantages in comparison with open surgery, such as a lower rate of blood transfusion, less postoperative pain, and a shorter hospital stay,6---8 which allows for the development of an early post-surgical discharge program. To this end, it is necessary to identify those factors which may predict its actual application using criteria of maximum effectiveness and safety. Our aim was to assess the safety of hospital discharge 24 h after laparoscopic radical prostatectomy (LRP), as well as to identify possible factors associated with longer hospital stays, in order to select the most suitable patients for early discharge and to improve these factors if possible.
Methods A total of 266 patients who had consecutively undergone extraperitoneal LRP between May 2007 and December 2010 were analyzed. All the patients had a clinical diagnosis of localized prostate cancer except for a patient with clinical stage cT3. The characteristics of the patients, including their demographic profile, their clinical features, anatomopathological data, and 90-day postoperative complications classified
according to the Clavien system9 were prospectively collected in our institutional database. All procedures were performed by 2 surgeons with a previous experience of 5 years in this kind of surgical technique. The surgical approach was extraperitoneal in all cases. Continuous suture was performed for urethrovesical anastomosis, whilst checking its tightness in an intraoperative manner. All patients were hospitalized on the same day of surgery and received prophylactic antibiotics with a dose of secondgeneration cephalosporin. Antithrombotic prophylaxis with low-molecular-weight heparin began on the first postoperative day in the absence of bleeding and was maintained for 3 weeks after hospital discharge. Anticoagulation in patients treated with dicoumarinics was reversed through an outpatient procedure. Limited ilio-obturator lymphadenectomy was performed in intermediate- and high-risk patients, according to the D’Amico classification.10 It should be mentioned that over the last 2 years (which were not included in this study) we have been performing extended lymphadenectomy in high-risk patients, thus replacing in such cases our customary extraperitoneal approach with a transperitoneal one, facilitating the exposure of the fundamental anatomical structures for the performance of this technique. All patients left the operating room with a type-B analgesic protocol consisting of paracetamol 1 g IV every 8 h alternating with metamizole 2 g IV every 8 h, adding dexketoprofen 50 mg IV as rescue analgesic if necessary. Preservation of neurovascular bundles was done in an extrafascial way in patients with adequate preoperative erectile function and low-risk tumor characteristics.
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Optimization of an early discharge program after laparoscopic radical prostatectomy Patients were discharged in less than 24 h only if they met the following requirements: absence of medical complications, drain output of less than 50 cc --- the latter being removed before discharge ---, normal oral tolerance, absence of significant hematuria by bladder catheter, and good functional recovery of the patient. All patients were discharged with a bladder catheter which was removed 10 days after surgery at our clinics. No cystourethrography was routinely performed prior to catheter removal. Patients were directly discharged to their home under the care of a family member, who had been given the necessary instructions by the nursing staff during their admission.
Statistical analysis Measurable variables are expressed as mean (standard deviation [SD]) or as median (interquartile range [IQR]). Quantitative variables were compared using Student’s ‘‘t’’ test or non-parametric tests after assessing the distribution of the variable (Kolmogorov---Smirnov). Qualitative variables are expressed as ratios and were compared using Pearson’s chi-square test with continuity correction or Fisher’s exact test, as appropriate. A logistic regression analysis was performed to evaluate the possible variables associated with a longer postoperative hospital stay (longer than 24 h). The significance level of all hypothesis-testing procedures was 0.05. The statistical analysis was carried out using SPSS 15.0 Statistical Package for Windows (SPSS Inc, Chicago, IL).
Results A total of 266 patients who underwent LRP were analyzed with a median follow-up of 34 months (9.5---53). The clinical and pathological characteristics of these patients are shown in Table 1. One hundred and sixty-nine (63.5%) patients were discharged within 48 h, 80 (30.1%) of whom where discharged after a hospital stay of less than 24 h, and meeting the inclusion criteria for early discharge described above. The mean hospital stay (SD) of the overall series was 2.9 days (3.08). Tolerance started early (≤8 h) in 243 patients (91.4%). Thirty-one patients (11.7%) experienced post-surgical complications which where divided according to the modified Clavien scale (Table 2). Six (2.2%) of these complications corresponded to the 24-h discharge group (4 of them were classified as Clavien I and 2 as Clavien II). Eighteen (6.8%) patients had to attend the Emergency Services due to these complications. Of the group of patients who were discharged within 24 h only one was readmitted due to hematuria. Of the 97 patients with a hospital stay longer than 48 h, 17 overstayed due to clinically relevant complications, which are included in Table 2. In the 80 remaining patients, the causes, in order of frequency, leading to a hospital stay exceeding 48 h were the following: long-term lymphorrhea output due to drainage (50), mild hematuria with no clinical and/or analytical impact,11 hemodynamically significant
Table 1
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Global series.
Variables
N (%) a
Age, years Charlson comorbidity scale (≥ 2) ASA I II III Previous abdominal surgery Total PSA, ng/mlb Prostate volume, mlb
64.3 (6.24) 84 (31.6) 18 (6.8) 142 (53.4) 101 (38) 78 (29.3) 6.4 (4.5) 33.5 (20.7)
Clinical stage T1c T2 T3
222 (83.5) 43 (16.1) 1 (0.4)
Biopsy Gleason ≤6 7 8---10
159 (59.7) 76 (28.6) 31 (11.7)
Mean surgical timea Bilateral lymphadenectomy Neurovascular bundle sparing a b
201.3 (32.1) 59 (22.2) 39 (14.7)
Data expressed as mean (SD). Data expressed as median (IQR).
Table 2 Postoperative complications classified according to modified Clavien. Complications
N (%)
Clavien I: Any deviation from a normal 18 (6.7) postoperative course, without the need for pharmacological, radiological, endoscopic, or surgical therapy. Treatments like antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physiotherapy are allowed Clavien II: Complications requiring 7 (2.6) pharmacological treatment with drugs other than those allowed for grade I complications, also including the need for blood transfusion or parenteral nutrition Clavien III: Clavien II: Complications requiring surgical, endoscopic, or radiological complications: (a) Intervention without need for general anesthesia (b) Intervention under general anesthesia Clavien IV: Complications involving life risk for the patient and requiring intensive care management (including complications of the central nervous system): (a) Single-organ failure (b) Multi-organ failure Clavien V: Death
5 (1.8)
1 (0.3)
0 (0)
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F.J. Díaz et al. Table 3
Univariate analysis of pre and postoperative variables (prediction of hospital stay).
Variable a
Age, years Charlson comorbidity scale (≥ 2) HBP Coronary artery disease Hypercholesterolemia Diabetes mellitus COPD
≤24 h; n (%)
>24 h; n (%)
p
63.9 28 28 3 23 16 13
64.4 56 95 17 52 26 19
0.49 0.23 0.01 0.09 0.50 0.15 0.12
(6.1) (35) (35) (3.8) (28.8) (20) (16.3)
(6.2) (30.1) (51.4) (9.2) (28.1) (14) (10.3)
0.69
ASA I II III
4 (5.2) 41 (53.2) 32 (41.6)
14 (7.6) 101 (54.9) 69 (37.5)
26 (32.5) 5.4 (3.2) 33 (25)
52 (28.1) 6.7 (5.2) 33.7 (19.3)
Clinical stage T1c T2 T3
69 (86.3) 11 (13.7) 0 (0)
153 (82.7) 32 (16.8) 1 (0.5)
Gleason of the biopsy ≤6 7 8---10
50 (62.5) 22 (27.5) 8 (10)
109 (58.6) 54 (29) 23 (12.4)
Mean surgical time (min)a Lymphadenectomy Neurovascular bundle sparing
199.61 (33.8) 9 (11.5) 18 (22.5)
202.14 (31.4) 50 (26.9) 21 (11)
Previous abdominal surgery Total PSA ng/dlb Prostate volume (ml)b
a b
0.28 0.08 0.97 0.65
0.44
0.60 0.006 0.01
Data expressed as mean (SD). Data expressed as median (range).
orthostatic dizziness,5 social or family situation of dependency and/or isolation,7 weekend discharges4 and low-grade fever not higher than 37.5 ◦ C.3 In the univariate analysis (Table 3) only the HTN, neurovascular bundle preservation and the performance of lymphadenectomy variables, were statistically different between both the groups (high < 24 h vs. high > 24 h). However, in the multivariate analysis (Table 4), once adjusted by the different variables, only the HTN variable with an OR of 1.98 (CI 95%: 1.13---3.47 [p = 0.016]) and the performance of lymphadenectomy with an OR of 2.56 (CI 95%: 1.18---5.56 [p = 0.017]) proved to be variables independently associated with hospital stays longer than 24 h. We propose a possible association between bundle preservation and the 2 variables which proved to be significantly associated with longer hospital stays; therefore, we carried out a chi-square test to evaluate such a possible association, objectifying a statistically significant difference among the preserved patients vs. the non-preserved ones
Table 4
regarding the performance of lymphadenectomy (5.3 vs. 22.2%; p = 0.006) and HTN (29 vs. 49.6%; p = 0.014).
Discussion Laparoscopic extraperitoneal radical prostatectomy has become the standard treatment for the management of localized prostate cancer at our center.11 Throughout our more than 10 years experience we have seen that patients achieve a rapid and safe postoperative convalescence. This has encouraged us to implement the 24-h discharge program. Our series showed the suitability of an early hospital discharge program, without an increase in postoperative complications, being adapted to the requirements and needs of our patients today, as well as to the current socioeconomic context. Despite the numerous modifications regarding the original technique and the greater experience of surgeons, open
Multivariate analysis.
Variable
OR
CI
p
HBP Lymphadenectomy
1.98 2.56
1.13---3.47 1.18---5.56
0.016 0.017
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Optimization of an early discharge program after laparoscopic radical prostatectomy radical prostatectomy still has inherent morbidity associated with it. In 1985 the mean stay of patients who underwent RP was longer than 2 weeks, with a mean time of 15 days for the perineal approach and 19 days for the retropubic approach.12 Since 1993, with a better understanding of surgery, as well as the introduction of significant improvements in the surgical technique and the anesthetic field, several groups have published mean hospital stays of around 5 days.13---15 This length of stay has steadily decreased even to 24 h in some centers, thanks to major technical developments such as the introduction of the laparoscopic approach and the recent introduction of robotic surgery,16 as well as the introduction of changes in conduct and postoperative care.17 Minimally invasive surgery offers potential advantages when compared with the classical open approach,18 one of them being a decrease in hospital stay, as it has already been shown in several published series.19---21 In order to implement an early discharge program at our center, we do not only need our efforts, but also to work in coordinated and close cooperation with the anesthesia department (avoiding long bed stays of patients) and with the nursing department (starting oral tolerance and moving the patient on the same day of surgery). According to the results of other published series, the laparoscopic approach has enabled us to reduce significantly the postoperative morbidity of our patients, with a lower transfusion rate, less need for analgesia, and fewer surgical wound complications.6---8,22 Ileus and abdominal distension have been seen in some patients of series 2 as the most common complications in patients who underwent LRP, thus extending the hospital stay.23,24 Aspects such as dietary management and postoperative analgesia are important when trying to reduce their incidence. Besides, as shown in the case of kidney surgery, the extraperitoneal approach may help prevent this possible paralytic ileus, probably caused in some cases by the presence of blood and/or carbonic acid in the intraperitoneal cavity.25 It should be mentioned, however, that this kind of laparoscopic approach (intraperitoneal or extraperitoneal) for radical surgery of the prostate remains an issue of discussion regarding its possible advantages and complications. While Eden et al.26 found differences with regard to operative time, hospitalization, and early continence in favor of the extraperitoneal approach, Erdogru et al.,27 in their comparative study, did not show statistically significant differences between both approaches. It is of remarkable interest to know whether there are also preoperative factors which may facilitate the selection of patients to whom this early discharge program can be safely applied, as well as to identify and modify those factors which may enable us to expand the group of patients to whom that program can be applied. Novara et al.28 identified the surgeon’s experience and prostate volume as predictors of possible postsurgical complications. Hruza et al.29 found the surgical time < 4 h, neurovascular bundle preservation, and the technique of anastomotic suture (by means of interrupted sutures) as predictors of postoperative complication. In our series, lymphadenectomy was introduced as a predictor associated with increased hospital stay. This fact is
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clinically linked to prolonged drainage debit, first factor related to stays > 48 h. HTN was also significantly associated with that longer stay. No clinical explanation was found to justify a longer hospital stay in the case of hypertensive patients. All patients showed normal tension levels during their hospital stay. In any case, and despite the clarifications and instructions given to the patient and their families prior to surgery, there is always an emotional factor in each patient (anxiety, concern for possible complications, insecurity) which, in the event of clinically non-relevant disorders (mild hematuria, orthostatic dizziness, low-grade fever), in a normal postoperative course, may compromise the feasibility of early discharge from a medical point of view, since it may be construed as a hurried discharge by the patient. On the other hand, it should be emphasized that, occasionally, structural and administrative constraints (nonexecuted discharges over the weekend/on public holidays with no physician present at the hospital, as in our case) may extend that stay with no clinical cause rendering it necessary. The most important limitations in our study were its retrospective nature, as well as the lack of an objective analysis evaluating the more than likely economic impact caused by earlier hospital discharge. Further prospective studies are required to confirm this fact and to analyze the most important risk factors for longer hospital stays.
Conclusions Early discharge in patients who underwent LRP is feasible and safe, and it can be performed within 24 h in a significant percentage of patients. In our series the performance of lymphadenectomy and HTN were factors associated with a longer hospital stay. Detailed information about prognosis and postoperative home care, previous training, the standardization of the procedure and multidisciplinary collaboration are the key to success in this kind of program.
Conflict of interest The authors declare that they have no conflict of interest.
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