Three years durability of the improvements in health-related quality of life observed after gastric banding

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Three years durability of the improvements in health-related quality of life (HR-QoL) observed after gastric banding Luca Busetto, Enrico Mozzi, Angelo Michele Schettino, Francesco Furbetta, Cristiano Giardiello, Giancarlo Micheletto, Vincenzo Pilone for the Italian Group for Lap-Band www.elsevier.com/locate/buildenv

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S1550-7289(14)00165-8 http://dx.doi.org/10.1016/j.soard.2014.04.016 SOARD1982

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Surgery for Obesity and Related Diseases

Cite this article as: Luca Busetto, Enrico Mozzi, Angelo Michele Schettino, Francesco Furbetta, Cristiano Giardiello, Giancarlo Micheletto, Vincenzo Pilone for the Italian Group for Lap-Band, Three years durability of the improvements in health-related quality of life (HR-QoL) observed after gastric banding, Surgery for Obesity and Related Diseases, http://dx.doi.org/10.1016/j.soard.2014.04.016 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Three years durability of the improvements in health-related quality of life (HR-QoL) observed after gastric banding.

Luca Busetto, Enrico Mozzi, Angelo Michele Schettino, Francesco Furbetta, Cristiano Giardiello, Giancarlo Micheletto, Vincenzo Pilone for the Italian Group for Lap-Band*

* Members and institutions of the Italian Group for Lap-Band (Gruppo Italiano Lap-Band – GILBPLUS) are listed in the Appendix.

Corresponding author: Dr. Luca Busetto. Dipartimento di Medicina, Clinica Medica I, Policlinico Universitario, Via Giustiniani 2, 35128 PADOVA – ITALY. Tel/Fax: (+39) 49 821 2149. E-mail: [email protected]

ACKNOWLEDGMENTS

The activities of the Italian Group for Lap-Band (Gruppo Italiano Lap-Band – GILBPLUS) are supported in part by Allergan Medical (Irvine, CA), the manufacturer of the LAP-BAND AP® Adjustable Gastric Banding System. However, any of the participating investigators or institutions received direct financial incentives for the enrollment of the patients in the study and the sponsor did not have any role in the analysis of the data collected in the database, in their interpretation, and in the preparation of the manuscript.

Short title: Quality of life after gastric banding.

APPENDIX

The following investigators and institutions participated in the Italian Group of Lap-Band (Gruppo Italiano Lap-band – GILBPLUS) prospective three-year observational study on the changes of HRQoL in patients treated with LAGB. The number of cases enrolled at each centre is in parentheses:

A.M. Schettino, C. Pari, G. De Palma, Casa di Cura S. Lorenzino, Cesena (52); V. Pilone, Facoltà di Farmacia e Medicina, Università degli Studi di Salerno, Salerno, P. Forestieri, R. Romeo, Scuola di Medicina e Chirurgia, Università degli Studi Federico II, Napoli (45); F. Furbetta, S. Gennai, N. Furbetta, U.O. di Chirurgia,Casa di Cura Leonardo, Empoli (43); E. Mozzi, S. Badiali, E. Lattuada, M. Zappa, Cattedra di Chirurgia Generale, Università degli Studi di Milano - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano (41); C. Giardiello, A. Borrelli, U.O.C. Chirurgia Generale, d’Urgenza e Metabolica, Centro per il trattamento Obesità, Presidio Ospedaliero Pineta Grande, Castelvolturno (30); G. Micheletto, V. Panizzo, Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti Università degli Studi di Milano - UOC di Chirurgia Generale e INCO Istituto Nazionale per la Chirurgia dell’Obesità, Istituto Clinico Sant'Ambrogio, Milano (20).

Three years durability of the improvements in health-related quality of life (HR-QoL) observed after gastric banding.

ABSTRACT

Introduction. Improvements in health-related quality of life (HR-QoL) occur after bariatric surgery. However, sustainability of these changes over time remain debated. Setting: Six Italian public and private bariatric surgery centers. Methods. Data collected in a prospective 3-year multicenter Italian study on changes of HR-QoL after laparoscopic adjustable gastric banding were used. HR-QoL has investigated with the SF-36 questionnaire. Hunger, satiety and the self-perceived effects of LAGB were recorded. Results. 230 patients (53 M and 177 F) were analyzed. BMI was 41.4±5.4 kg/m2 at baseline, declined to 33.8±5.8 kg/m2 12 months after surgery (P<.001), and further reduced to 31.9±5.1 kg/m2 36 months after surgery (P<.001 vs 12 months). Scores in the SF-36 subscales were lower than in the general Italian population at baseline. The physical component summary score (PCS) was 51.9±11.6 at baseline, improved to 79.2±15.4 at 12 months (P<.001), and stabilized to 79.8±15.6 at 36 months. The mental summary score (MCS) was 52.3±11.8 at baseline, improved to 75.2±17.3 at 12 months (P<.001), and stabilized to 74.2±17.5 at 36 months. A decline >10 points between 12 and 36 months in the summary scores was observed in 22.0% of the patients for PCS, and in 26.8% for MCS. In a multiple linear regression analysis, deterioration in HR-QoL in the 1236 months period was associated to the presence of better HR-QoL values at 12 months and to a more pronounced reduction of the self-perceived effect of the banding at 36 months. Conclusion. Improvements in HR-QoL observed in the first year after surgery maintained up to the third year after gastric banding.

Keywords: Health-related quality of life; morbid obesity; gastric banding

INTRODUCTION

Health-related quality of life (HR-QoL) is a complex issue and refers to the overall effects of medical conditions on physical, mental, and social functioning and well-being as subjectively evaluated and reported by a patient (1). HR-QoL was found to be markedly impaired in morbid obese candidates to bariatric surgery (2-6). The entity of the impairment of HR-QoL in obese patients is related to the severity of obesity (7), but is also influenced by the presence of comorbidities (6,8,9), mental disorders (9,10), and low socio-economic status (11,12). Bariatric surgery is highly effective in inducing long-term sustained weight loss in morbid obese patients and this weight loss was found to be associated with substantial health benefits. Compared with usual care, bariatric surgery was associated with a long-term reduction in overall mortality, decreased incidences of diabetes, myocardial infarction, stroke and cancer, and higher diabetes remission rates (13). These important effects on physical health should translate in a significant improvement in HR-QoL, and indeed positive changes in HR-QoL are frequently reported in the first period following bariatric procedures (2-6,14). However, sustainability of these changes over time is less certain and very few reports prospectively analyzed HR-QoL changes in studies with a more prolonged follow-up (15-17). In 2008, we launched in Italy a prospective study with the specific objective to analyze changes of HR-QoL in the first three years after bariatric surgery in a sufficiently large multicenter series of morbid obese patients treated with the laparoscopic adjustable gastric banding (LAGB). We previously reported that HR-QoL was severely impaired at baseline in the patients enrolled in the study, particularly in those affected by mental comorbidity and/or eating behaviour disorders (18). We also reported that HR-QoL substantially improved in the first year after banding, particularly in patients with lower baseline HR-QoL levels (19). In the present report, we utilize the three-year follow-up data of the study to analyze the sustainability of these improvements over time and to investigate factors involved in HR-QoL maintenance or deterioration.

METHODS

Patients and procedures The Italian Group for Lap-Band (Gruppo Italiano Lap-Band – GILBPLUS) is a centralized electronic database collecting operative and follow-up data from Italian surgical centers that utilize the Lap-Band® System (Allergan Medical, Irvine, CA) as LAGB procedure. Participation of the centers to the database is on a voluntary basis. In 2008, GILBPLUS designed an ongoing prospective three-year observational study on the changes of HR-QoL in patients treated with LAGB. Participation of the GILBPLUS centers to this study was on a voluntary basis and participating centers agreed to comply with a minimal follow-up rate of 75% in order to maintain their right to participate. General design of the study has been previously described (18,19). Briefly, inclusion and exclusion criteria was in accordance to standard international guidelines for bariatric surgery (20,21). Centers maintain their full autonomy about the selection of the patients for LAGB surgery or for other bariatric procedures. From June 2008 to December 2009, 383 morbid obese candidates to LAGB enrolled in 13 Italian bariatric surgery centers participating to the GILBPLUS study and underwent LAGB surgery (18). Each patients gave his written informed consent for the study participation. At the end of the first year of follow-up, two centers were excluded from the study for inability to provide acceptable follow-up rates and one center has withdrawn its participation for personal reasons. Therefore, 334 participants enrolled in 10 centers participated in the evaluation performed one year after surgery (19). At the end of the three years study, additional four centers did not reach predefined levels of follow-up rate and were excluded. Therefore, only data referring to the 230 participants enrolled in the 6 centers with sufficient rates of follow-up were used for the present report. No significant differences were found in the baseline characteristics of the patients finally included in the study and in the excluded patients (data not shown). A detailed pre-operative multidisciplinary assessment was performed in all centers (18,19) and all clinical data were prospectively stored in a centralized electronic database. All LAGB procedures

have done on an inpatient basis by using the LAP-BAND AP® Adjustable Gastric Banding System (Allergan Medical, Irvine, CA). Dietary and physical activity prescriptions were homogeneous through centers and have been previously described in details (18,19). Follow-up outpatient visits were scheduled at 1, 3, 6, and 12 months post-operatively and yearly thereafter. Additional visits can be scheduled as clinically requested. Band adjustments were performed under radiological control and the levels of band filling recorded as the volumes (ml) of saline solution progressively inflated into the band after surgery.

Study measurements We utilized for the present report study measurements performed at baseline and at 12, 24 and 36 months after surgery. All anthropometric measurements have made with the subjects wearing only light clothes without shoes (18,19). BMI was calculated as weight (kg) divided by the height-squared (m2). The standardized criteria applied for the diagnosis of major comorbidities at baseline (type 2 diabetes, hypertriglyceridemia, low HDL-cholesterol level, hypertension, sleep apnea syndrome and osteoarthritis) have been previously reported (18,19). Briefly, diabetes was defined as a fasting plasma glucose level

126 mg/dl or use of any anti-diabetic drug; hypertriglyceridemia as fasting

triglycerides 150 mg/dl; low HDL as HDL-cholesterol levels <40 mg/dl in men and <30 mg/dl in women; hypertension as blood pressure 140/90 mmHg or use of any anti-hypertensive drug. Sleep apnea was diagnosed on the basis of diurnal and/or nocturnal symptoms, without the mandatory use of an instrumental registration of the breathing pattern during sleep. Osteoarthritis was defined as the presence of chronic pain at the weight-bearing joints with or without the use of pain-suppressant medications (18,19). The same diagnostic criteria were used for the evaluation of comorbidities during follow-up: patient testing positive at baseline and negative at the follow-up visits were defined as in remission for any given comorbidity. As part of the pre-operative multidisciplinary assessment, eating behavior disorders, eating attitudes and psychological symptoms were evaluated in all patients during a clinical unstructured interview performed by an experienced psychologist. Patients

with mild-to-moderate major depressive disorder or dysthymic disorder were categorized as affected by depression (18,19). The standardized criteria applied for the definition of eating behavior disorders and eating attitudes (binge eating, sweet eating and nibbling) have also been previously reported (18,19). Hunger at morning and satiety after meal were graded by patients by using a 0-10 visual scale. At the post-operative evaluations patients were also asked to rate the self-perceived effect of LAGB on own caloric intake on a 0-10 visual scale. Dysphagia, simply defined as difficult swallowing for all type of solid food, and reflux were categorized as absent or present. The frequency of episodes of food regurgitation during meals were categorized on a 0-3 scale (0: no episodes of vomiting during the previous month; 1: no more than 5 episodes of vomiting during the previous month; 2: no more than 20 episodes of vomiting during the previous month; 3: more than 20 episodes of vomiting during the previous month or daily vomiting) (22). The frequency of episodes of heartburn was categorized with a similar 0-3 scale. Health-related quality of life (HR-QoL) was analyzed with the standard (4-week) recall version 2.0 of 36-item Health Survey (SF-36) questionnaire form. The SF-36 measures the following 8 eight subscales: physical functioning (PF), social functioning (SF), role limitations due to a physical problem (RP), role limitations due to an emotional problem (RE), mental health (MH), vitality (VT), bodily pain (BP), and general health (GH) perception. The eight subscales form two distinct higher-ordered summary scales: the physical component summary scale (PCS) and the mental summary component scale (MCS) (23). SF-36 has an Italian validated version and normative values for the Italian adult population (24).

Statistical analysis All statistical analyses were performed using SPSS statistical package, version 19.0 (SPSS, Chicago, IL). In all analyses, a P-value <0.05 was considered to be statistically significant. Frequencies, mean values and standard deviations were used to describe the baseline characteristics

of the patients. Differences in the values observed before and after surgery were evaluated by paired Student’s t-test. Late changes in HR-QoL have been quantified as the difference between the values of the two SF-36 summary scales (PCS and MCS) observed at 36 and 12 months after surgery. Determinants of PCS and MCS late changes were firstly analyzed by simple correlation analysis. Categorical covariates was coded as absent (=0) or present (=1). Tested variables were the followings: sex (0=male; 1=female), age at surgery, BMI at baseline, BMI at 12 and 36 months, baseline and 12 months PCS and MCS scores, baseline physical comorbidities (type 2 diabetes, hypertension, sleep apnea, osteoarthritis), baseline depression and eating behavior disorders (binge eating disorder, sweet eating, nibbling), remission of physical comorbidities at 12 and 36 months, dysphagia and reflux at 12 and 36 months, regurgitation and heartburn scores at 12 and 36 months, morning hunger and after meal satiety at 12 and 36 months, self-perceived effect of LAGB on own caloric intake at 12 and 36 months, percent excess weight loss (%EWL) level at 12 and 36 months, difference in %EWL between 12 and 36 months (weight regain), differences in morning hunger and after meal satiety between 12 and 36 months, difference in the self-perceived effect of LAGB on own caloric intake between 12 and 36 months. Variables found to be significantly associated to late changes in PCS or MCS scores in simple correlation analysis were finally entered in a stepwise multiple linear regression model for testing their independent contribution to the variability of late PCS or MCS changes. Predictors were selected at a significance level of <0.05. As criterion for removing variables in the stepwise regression, a p value for F of 0.10 was chosen.

RESULTS

The baseline characteristics of the 230 morbid obese participants in the GILBPLUS prospective three-year observational study on the changes of HR-QoL in patients treated with LAGB are reported in Table 1. All surgical procedures were performed by laparoscopic approach. LAPBAND AP® was successfully positioned in all patients, with no peri-operative mortality. The rate of intra-operative complications was 2.1% and only two patients (0.8%) presented early postoperative medical or surgical complications. Mean operative time was 68.5±33.4 min (range 20-240 min) and mean hospital stay was 2.7±4.1 days (range 1-9 days). Anthropometric data collected in the three years of the study are reported in Table 2. Follow-up rate was 92.6% at 12 months (213 patients), 90.4% at 24 months (208 patients), and 80.0% at 36 months (184 patients). Most of the weight loss was observed in the first year after surgery, but a further significant reduction in body weight occurred also in the second year. BMI at 36 months (31.9±5.1 kg/m2) was significantly different both from baseline BMI (41.4±5.4 kg/m2; P<.001) and from BMI at 12 months (33.8±5.8 kg/m2; P<.001). In the period between the first and the third years of observation, 59.4% of the patents had a further significant weight loss (difference in %EWL between the two observations >5%), whereas 21.8% experienced a weight regain (difference in %EWL between the two observations < -5%). Fourteen cases of pouch dilatation (6.1%) and six cases of esophageal dilatation (2.6%) were observed during the study. Band removal were requested in a total of 5 patients (2.2%): 3 cases of pouch dilatation with slippage of the band, 1 case of erosion and 1 case of permanent dysphagia despite complete band deflation. No further band related redo surgery was required. Seven port complications were observed (2 port-tube leak, 4 port rotations and 1 port infection) and three patients (1.3%) required minor port-related surgery. Three female patients had a normal pregnancy during the study. Remission of type 2 diabetes was observed in 87.0 of cases at 12 months and in 71.4% of cases at 36 months. Remission of hypertension was observed in 86.2% of cases at 12 months and in 83.7% of cases at 36 months.

Symptoms of sleep apnea disappeared in 100.0% of cases at 12 months and in 93.8% of cases at 36 months. Pain related to osteoarthritis disappeared in 85.7% of cases at 12 months and in 50.0% of cases at 36 months. Hunger at morning after an overnight fast, satiety after a standard meal, the self-perceived effect of LAGB on own caloric intake, the band filling levels and the observed frequencies of gastric symptoms are reported in Table 3. Hunger at morning after an overnight fast was graded as significantly reduced by the patients one year after surgery, and further significantly declined at the following two annual evaluations. On the contrary, satiety after a standard meal peaked at 12 months and subsequently declined returning to the baseline levels. A similar trend was observed for the self-perceived effect of LAGB on caloric intake as graded by the patients. Band filling volumes progressively increased during the study. The frequencies of gastric symptoms did not shown significant changes during the three years of follow-up, but a trend toward a progressive increase in heartburn, reflux and dysphagia was observed. HR-QoL levels before and after LAGB are reported in Table 4. Before surgery, scores in the 8 SF36 subscales were lower than in the general adult Italian population. As previously reported (19), a highly significant improvement (P<.001) was observed in all the 8 SF-36 subscales at the 12 months evaluation compared to baseline values. Values at 24 and 36 months remained very close to the values at 12 months and to the Italian normative values for all the SF-36 subscales. Comparing the values at 12 and 36 months, a significant reduction was observed only for SF (P<.05) and MH (P<.05). The Physical component summary scale (PCS) and the Mental component summary scale (MCS) are also reported in Table 4. Both summary scales significantly improved in the first year after LAGB and remained stable thereafter. No significant differences were observed in PCS and MCS between the evaluation at 12 months and the final evaluation. The late changes in HR-QoL were also investigated by calculating the differences in PCS and MCS values observed at 12 and at 36 months after surgery. An increase of more than 10 points between 12 and 36 months was observed in 22.0% of the patients for PCS and in 26.8% of the patients for

MCS. On the other hand, a decrease of more than 10 points in PCS or MCS was observed in 17.0% and in 15.5% of the patients respectively. Determinants of late (12-36 months) PCS and MCS changes were analyzed by simple correlation analysis. Tested variables are reported in the Statistical Analysis section and the variables found to be significantly associated to late changes in PCS or MCS scores are reported in Table 5. Late improvements in PCS scale were found to be associated with higher PCS values at baseline and with the presence of sleep apnea syndrome before surgery. On the contrary, the presence of better PCS and MCS levels at 12 months was associated to a decline of both scales in the following two years. Late improvements in PCS and MCS scales were also negatively associated with the level of hunger at morning at 36 months and positively associated to satiety after a meal at 36 months (only for PCS) and with the self-perceived effect of the band on own caloric intake at 36 months. Finally, a decline in satiety after a meal and a decline in the self-perceived effect of the band between 12 and 36 months were associated with a decline in PCS and MCS in the same period. No correlations were found between late PCS and MCS changes and the degree of weight loss or weight regain. The independent contribution to these variables to the variability in late PCS or MCS changes was finally tested in a stepwise multiple linear regression model analysis. Late improvements in PCS were independently associated to high baseline PCS levels (P = .000), low PCS levels at 12 months (P=.000), low hunger at morning at 36 months (P = .001), and high self-perceived effect of the band at 36 months (P = 0.006). Similarly, late improvements in MCS were independently associated to low MCS levels at 12 months (P = .000), low hunger at morning at 36 months (P = .000), and high self-perceived effect of the band at 36 months (P = 0.000). Explained variance was 42.2% for PCS late change variability and 38.3% for MCS late change variability.

DISCUSSION

We report in this paper the final results of the Italian three-years multicenter prospective study on the changes of HR-QoL in morbid obese patients treated with LAGB. Baseline data of the study have been previously published and confirmed that morbid obese candidates to obesity surgery had HR-QoL levels substantially lower than the normative values registered in the normal Italian adult population (18). In our experience, baseline HR-QoL, particularly in the mental component, was negatively affected more by the presence of depression and eating behaviour disorders than by physical comorbidities or BMI levels (18). We also previously reported that HR-QoL, both in the physical and in the mental domain, significantly improved in the first year after surgery (19). HR-QoL improvement was greater in patients with a poor HRQoL level before surgery and in patients with a greater weight loss after surgery. Moreover, a high satiety after meal and a high self-perceived effect of the banding on caloric intake were both associated to a greater short-term improvement of HR-QoL (19). In the present report, we finally proved that the improvement in HR-QoL observed in the first year after surgery can be maintained at least for other two years. Deterioration of both mental and physical components of HR-QoL after the first year was more frequently observed in patients who subjectively reported a reduction in the effect of their banding and an increase of the sense of hunger at morning. In conclusion, the Italian three-years multicenter prospective study on the changes of HR-QoL in morbid obese patients treated with LAGB confirmed the efficacy of restrictive surgery in improving HR-QoL at least in the medium term. The changes of HR-QoL have been frequently analyzed in the first year after restrictive surgery (26,14)

, but very few study prospectively examined HR-QoL changes over a more extended follow-up.

Karlsson et al. examined trends in HR-QoL over 10 years in the Swedish obese subjects (SOS) intervention study, a controlled longitudinal trial on the health effects of weight loss in the severely obese (15). In this study, HR-QoL largely followed phases of weight loss, weight regain and weight

stability: peak improvements in HR-QoL were observed during the first year of weight loss, whereas the weight regain phase (years 1-6 of follow-up) was accompanied by a gradual decline in HR-QoL, and the 6-10 years period was characterized by relatively stable levels in both weight and HR-QoL. Despite these trends, net gains compared to baseline were noted at 10 years in all HRQoL domains (15). Disease-specific and general HR-QoL were measured preoperatively and 1 and 5 years postoperatively following LAGB by Helmiö et al. (16). In this study, LAGB significantly improved HR-QoL up to 5 years postoperatively, but HR-QoL remained at a lower level than that of the age- and gender-standardized general population (16). Finally, Maud et al. prospectively analyzed HR-QoL with the SF-36 questionnaire in the first three years after LAGB and observed a significant improvement in HR-QoL, with a return to normal values in the first year after surgery and a stability of the HR-QoL levels thereafter (17). The results of this latter study were substantially replicated in our analysis, conducted by using a very similar methodology and an identical followup length. The relevance of the degree of weight loss in determining the HR-QoL changes after LAGB has been examined in several studies. Post-operative weight loss certainly plays a role in rapidly improving HR-QoL shortly after surgery (17). However, Dixon et al. demonstrated that %EWL at 1 year after LAGB was of little predictive value of improved HR-QoL (2) . Moreover, equivalent improvements of HR-QoL were observed in the first year after gastric bypass and gastric banding (4)

or after sleeve gastrectomy and gastric banding (5), despite substantial differences in %EWL

between LAGB and the two more invasive procedures. We previously confirmed that in our study %EWL in the first year after LAGB was only moderately related to improvements in physical and mental summary scores of SF-36 (19). More late changes in HR-QoL were described as related to body weight fluctuations in some studies (15), but not in others (16). These discrepancies may be due to differences in follow-up length and weight trajectories. In the late phase of follow-up analyzed in this report, both patients with further weight loss and patients with weight regain were included and we have not observed any relationships between weight changes and HR-QoL. In conclusion,

weight loss is certainly one factor in explaining the improvements of HR-QoL observed after surgery, but changes in HR-QoL are not entirely explained by body weight reduction. Significantly greater fasting and postprandial satiety levels after banding have been previously demonstrated in a randomized blind crossover study (25). Hunger at morning, satiety after a meal and the patients self-perceived effect of the banding on own caloric intake have been prospectively measured with a standard methodology in our study. Whilst the significant reduction of hunger at morning observed in the first year after surgery was maintained until the end of the three years follow-up, the sense of satiety after meal and the self-perceived effect of the banding tended to decline over time. Satiety after a meal at 36 months was scored by the patients not significantly different than at baseline, despite a progressive increase in the filling volume of the band. We previously reported that both satiety after meal and the self-perceived effect of the banding on own caloric intake were positive independent predictors of the changes in physical and mental components of HR-QoL observed in the first year after surgery (19). The importance of these elements in determining HR-QoL levels was now confirmed also in the maintenance phase, with patients having a reduction in the self-perceived effect of the banding or an increase in hunger being more prone to have a deterioration of their HR-QoL during the second and third years after surgery. This seems to confirm our hypothesis that the help the patients receive from the banding in controlling eating behavior and caloric intake may be important in determining the subjective overall satisfaction of the patients with the procedure. LAGB, as any other bariatric restrictive procedure, is associated with the emergence of some gastro-intestinal side effects and complications, with the most frequent complain being represented by episodes of food regurgitation during or shortly after meal. The frequency of food regurgitation has been reported to be high in some study (26) and the inability to consume a range of foods due to the regurgitation was cited as the most disturbing problem in a significant proportion of patients treated with LAGB (26). On the contrary, we previously reported a low frequency of food regurgitation and other gastro-intestinal symptoms, reflux in particular, in the first year after LAGB

(19)

. Despite a trend toward a progressive increase in heartburn, reflux and dysphagia, the frequency

of gastric symptoms did not shown any significant change during the second part of follow-up reported in the present report. No relationships between gastro-intestinal symptoms (dysphagia, reflux, food regurgitation and heartburn) and the changes of HR-QoL observed after surgery were observed, neither in the first year of observation (19), neither in the last two years of the study. In summary, we may confirm that the frequency of gastro-intestinal side effects remains low in the first three years after LAGB and that their occurrence had little impact on patients satisfaction after surgery. This is in agreement with previous cross-sectional studies showing a marginal role of gastro-intestinal side effects in determining overall patients satisfaction after LAGB (26). Our study has several methodological limitations that have been previously addressed and discussed (19)

. Briefly, total number of follow-up visits in study was quite low and this low frequency of

follow-up contacts may have had a negative impact on excess weight loss and on the reliability of our results. Moreover, the diagnosis of physical comorbidities at baseline and after surgery, the presence of depression and eating behavior disorders, and the frequency of gastro-intestinal symptoms have been tested with the use of a very simple clinical methodology and without the use of more precise and formal testing. Most of the outcomes of this study are self-reported and no systematic attempts of correlating symptoms with the results of more objective instrumental tests (upper endoscopy or barium swallow study) were performed. Moreover, we analyzed HR-QoL changes with the use of a single general instrument, the 36-item Health Survey (SF-36) questionnaire form. Finally, the number of patients and centers participating to the study progressively reduced during follow-up. We tried to compensate the drop-out phenomenon by retaining into the study only patients belonging to centers with a sufficient follow-up rate, but this policy did not completely exclude the possibility of a type 2 bias.

CONCLUSION

In conclusion, our results confirmed that the improvements in HR-QoL observed in the first year after surgery may be maintained up to the third year after laparoscopic adjustable gastric banding. The degree of weight loss and/or weight maintenance seems to have a little role in graduating HRQoL changes, at least in this time frame. A high self-perceived efficacy of the banding in eating control was important in improving HR-QoL shortly after surgery as well as in maintaining high HR-QoL levels in a more extended follow-up.

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Table 1. Baseline characteristics in 230 morbid obese patients enrolled in the Italian Group for LapBand (GILBPLUS) prospective three-year observational study on the changes of health-related quality of life after laparoscopic adjustable gastric banding.

Baseline characteristics Male sex (%)

23.0 %

Age, years

38.9±10.1

Body weight, kg

113.8±19.1

Body Mass Index, kg/m2

41.4±5.4

Type 2 diabetes (%)

10.0 %

Hypertriglyceridemia (%)

9.6 %

Low HDL levels (%)

9.6 %

Hypertension (%)

28.3 %

Sleep Apnoea (%)

8.7 %

Osteoarthritis (%)

12.2 %

Binge Eating (%)

5.2 %

Sweet Eating (%)

0.4 %

Nibbling (%) Depressive symptoms (%)

12.2 % 8.3 %

Mean values ± Standard Deviation were reported for numerical variables. HDL: High density lipoproteins.

Table 2. Anthropometric data in the Italian Group for Lap-Band (GILBPLUS) prospective threeyear observational study on the changes of health-related quality of life after laparoscopic adjustable gastric banding.

Baseline

12 months

24 months

36 months

113.8±19.1

92.8±18.6 ***

87.3±18.8 *** §§§

87.3±18.8 *** §§§

BMI, kg/m2

41.7±5.6

35.8±5.5 ***

34.3±5.7 *** §

31.9±5.1 *** §§§

%EWL, %

-----

29.2±15.9

39.6±25.8 §

49.2±22.4 §

Body weight, kg

BMI: Body Mass Index. %EWL: %Excess Weight Loss. Paired Student’s t-test versus baseline: * = P<.05; ** = P<.01; *** = P <.001. Paired Student’s t-test versus 12 months: § = P <.001.

Table 3. Hunger at morning, satiety after a meal, self-perceived effect of gastric banding on own caloric intake, band filling levels and frequencies of gastric symptoms in the Italian Group for LapBand (GILBPLUS) prospective three-year observational study on the changes of health-related quality of life after laparoscopic adjustable gastric banding.

Baseline

12 months

24 months

36 months

Hunger at morning

4.4±2.7

3.7±2.4 ***

3.3±2.2 ***§§

3.0±2.2 ***§§§

Satiety after meal

6.8±2.8

8.1±2.1 ***

7.8±2.5 **

7.0±2.7 §§§

Effect of banding

-----

8.5±1.9

8.1±2.3

7.3±2.6 §§§

0.0±0.0

4.6±2.3 ***

5.2±2.3 ***§§§

5.4±2.3 ***§§§

Vomiting score≥2 (%)

1.4

15.0

18.1

15.0

Heartburn score≥2 (%)

9.1

11.3

11.5

15.0

Dysphagia (%)

-----

1.9

2.4

3.5

Reflux (%)

-----

0.0

2.9

4.6

Filling volume (ml)

Hunger at morning, satiety after meal and the self-perceived effect of LAGB on caloric intake were graded by the patients using a 0-10 visual scale. Band filling volume was reported as the total volume (ml) of saline solution progressively inflated into the band after surgery. Vomiting score≥2 denotes patients with more than 5 episodes of food regurgitation during meals in the preceding month. Heartburn score≥2 denotes patients with more than 5 episodes of heartburn in the preceding month. Paired Student’s t-test versus baseline: * = P<.05; ** = P<.01; *** = P <.001. Paired Student’s t-test versus 6 months: § = P <.05; §§ = P <.01; §§§ = P <.001.

Table 4. Health-related quality of life (HR-QoL) levels during the Italian Group for Lap-Band (GILBPLUS) prospective three-year observational study on the changes of HR-QoL after laparoscopic adjustable gastric banding. HR-QoL has investigated with the SF-36 questionnaire.

Normative

Baseline

12 months

24 months

36 months

PF

84.5±23.2

58.5±22.5

86.7±18.6***

81.8±21.9***§

87.0±17.4***

RP

78.2±35.9

31.2±32.8

88.6±24.5***

86.0±26.4***

90.6±19.8***

BP

73.7±27.6

61.9±25.7

82.4±21.0***

82.0±23.4***

82.4±24.4***

GH

65.2±20.9

55.2±21.7

76.5±18.0***

71.7±17.7***§

74.1±20.2***

VT

61.9±20.7

59.4±21.2

64.7±20.7***

60.3±21.3

66.0±17.4

SF

77.4±23.2

52.7±20.7

79.2±22.0***

76.7±23.7***

74.6±25.4***§

RE

76.2±37.2

62.7±24.8

88.4±25.9***

82.1±31.6***

90.7±23.3***

MH

66.6±20.9

33.0±35.3

68.7±20.4***

66.0±21.1***§

65.7±20.3***§

PCS

-----

51.9±11.6

79.2±15.4***

77.3±17.3***

79.8±15.6***

MCS

-----

52.3±11.8

75.2±17.3***

71.1±19.6***§

74.2±17.5***

The SF-36 measures the following 8 eight subscales: physical functioning (PF), role limitations due to a physical problem (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role limitations due to an emotional problem (RE), mental health (MH). The eight subscales form two distinct higher-ordered summary scales: the physical component summary scale (PCS) and the mental summary component scale (MCS). Normative: normative SF-36 values for the Italian adult population (24). Paired Student’s t-test versus baseline: *** = P <.001. Paired Student’s t-test versus 6 months: § = P <.05.

Table 5. Variables found to be significantly associated to late changes in Physical component summary score (PCS) or Mental component summary score (MCS) in the Italian Group for LapBand (GILBPLUS) prospective three-year observational study on the changes of health-related quality of life after laparoscopic adjustable gastric banding.

Change in PCS

Change in MCS

PCS scale before surgery

0.206 **

----------

Sleep apnea syndrome at baseline

0.166 *

----------

PCS scale 12 months after surgery

-0.395 ***

-0.291 ***

MCS scale 12 months after surgery

-0.278 ***

-0.437 ***

Hypertension at 12 months

0.229 **

0.185 *

Hypertension at 36 months

0.271 **

----------

Hunger at morning at 12 months

-0.303 ***

----------

Hunger at morning at 36 months

-0.181 *

-0.193 *

Satiety after meal at 36 months

0.280 **

----------

Perceived effect of band at 36 months

0.278 **

0.217 *

Difference in satiety 12-36 months

-0.218 *

-0.156 *

Difference in effect of band 12-36 months

-0.191 *

-0.175 *

Simple linear correlations coefficients are reported. * = P<.05; ** = P<.01; *** = P <.001. Late changes were defined as the difference between the value observed at 36 months and the values observed at 12 months after surgery, with positive values indicating an improvement of HR-QoL and negative values indicating a worsening of HR-QoL. Tested variables are reported in the Statistical Analysis section.