First National Safety Audit of Laparoscopic Sleeve Gastrectomy in Singapore

Transcription

1 Title: Authors: First National Safety Audit of Laparoscopic Sleeve Gastrectomy in Singapore June Lee Andrew Wong Davide Lomanto Asim Shabbir Jimmy So Weng Hoong Chan Alvin Eng Anton Cheng Kee Yuan Ngiam Ganesh Ramalingam Tzu Jen Tan Aaryan Koura Jaideepraj Rao Yuk Man Kan Shanker Pasupathy

2 Abstract Background: Obesity is the world s most prevalent metabolic disease and continues on a rising trend. In Singapore, this incidence rose from 6% in 1998 to 6.9% in 2004, then to 10.8% in Bariatric surgery produces significant weight loss with improvements in obesity-related comorbidities and survival. Laparoscopic sleeve gastrectomy, first performed as the initial step of a staged laparoscopic duodenal switch, is increasingly performed as a stand-alone bariatric procedure. From 5% of all bariatric procedures in 2006, laparoscopic sleeve gastrectomy is now the most commonly performed locally. We present our first nationwide audit of its safety results. Methods: All patients who received laparoscopic sleeve gastrectomies from 15 June 2006 (when the first procedure was performed in Singapore) to 15 June 2014 were included in this study. The safety profile of laparoscopic sleeve gastrectomy was determined by assessing the early 30-day morbidity and mortality rates, as well as the late 1-year morbidity and mortality rates. Results: A total of 641 patients underwent laparoscopic sleeve gastectomy in the study Period. Our study population was predominantly female (55.9%) with a mean age of 39.1 ± 11.0 years, a mean body weight ± 27.3, and a mean BMI of ± 8.39 kg/m2. After excluding patients who had defaulted, 630 patients were identified for assessment of early complications. The 30-day morbidity rate was 3.49%, with 7 leaks (1.11%), 2 strictures (0.32%), 4 haemorrhages (0.63%), 4 wound infections (0.63%), 5 others (0.63%; including the 1 mortality from a pulmonary embolism). The 30-day mortality rate was 0.18%. Late mortality and morbidity rates were calculated for 543 patients who reached at least a 1-year post-operative follow up. Of this group, 134 patients (24.68%) were lost to follow up and were excluded from analysis. There were no late mortalities in this group of patients. The overall late morbidity rate was 5.87%, with 1 late leak (0.24%), 2 strictures (0.49%), 19 de Novo gastroesophageal reflux (4.65%) and 1 incisional hernia (0.24%). Conclusions: Laparoscopic sleeve gastrectomy has a good safety profile locally, with low morbidity and mortality rates similar to published reports.

3 Introduction Obesity is the world s most prevalent metabolic disease and continues to be on a rising trend 1, 2. In Singapore, the incidence of obesity (body mass index (BMI) greater than 30 kg/m 2 ) rose from 6.9% in 2004 to 10.8% in Bariatric surgery has been shown to be the only treatment modality to produce significant and sustainable weight loss with a concomitant improvement in obesity-related comorbidities and survival 4-6. However, due to a post-operative fatality in 2006 and the consequent negative publicity, bariatric surgery in the form of laparoscopic adjustable gastric banding was met with apprehension and largely rejected by patients. This impeded the advancement of bariatric surgery locally, until the advent of laparoscopic sleeve gastrectomy (LSG) 7. LSG has emerged as a stand-alone bariatric procedure and has quickly gained popularity in Asia 8. It has been shown to be a relatively simpler procedure than the malabsorptive type of bariatric surgeries, with a shorter learning curve 9, and yields greater weight loss and comorbidity resolution than the restrictive laparoscopic gastric banding 10, 11. LSG has been increasingly adopted by local surgeons and is now the most common bariatric procedure performed in Singapore, rising from 5.5% of all bariatric procedures in 2006 to more than 50% of cases by However, LSG is not completely without risk. The Achilles heel of the procedure is the small incidence of leaks which tend to occur high up on the sleeved stomach, close to the gastric cardia at the angle of His. Furthermore, recent reports describe an increasing rate of gastroesophageal reflux following LSG. In order to clarify these concerns and accurately record the safety profile of LSG, the Obesity and Metabolic Surgery Society of Singapore (OMSSS), performed a nationwide audit. Method Prospectively maintained bariatric surgery databases of all 6 public institutions in Singapore were analysed. All consecutive patients who underwent LSG as a single-stage procedure for the treatment of obesity were identified from the database. The study period was from 15 June 2006 (when the procedure was first performed in Singapore) to 15 June 2014 a total of 8 years. Patients were eligible for bariatric surgery as a medical intervention for severe or morbid obesity according to the Obesity Clinical Practice Guidelines 13 published by the Ministry of Health, Singapore in These guidelines are similar to the Asia-Pacific Bariatric Surgery Society Guidelines for Bariatric Surgery Patients were evaluated and managed by a multidisciplinary team in each hospital. The surgical technique, in essence, consisted of a narrow gastric sleeve created over a bougie using an endoscopic stapler. The greater curve, including the body and fundus of the stomach was then removed. Bougie size ranged from 36 52F (early in the series). Stapling was commenced 2-6 cm from the pylorus and the use of buttress material, tissue glue or over-sewing was left to each individual surgeon s discretion. Anonymised patient information was provided from each centre s bariatric co-ordinator according to the predetermined patient data points for this study. These include patient demographics, surgical complications and mortality rates. Early complications and mortality were defined as occurring within 30 days. Late complications and mortality were calculated

4 only for patients who have reached a 1-year period of follow-up. Patients who defaulted follow-up were excluded from analysis (figure 1). Results 641 patients underwent LSG between June 2006 and June patients (1.72%) defaulted within 30-day 630 patients analysed for early 30-day mortality and morbidity rates 543 patients would have reached at least 1 year post-op 134 patients (24.68%) defaulted within 1 year 409 patients analysed for late 1-year mortality and morbidity rates Figure 1. Study population identified for analysis A total of 641 patients underwent laparoscopic sleeve gastrectomy in the study period (table 1). Our study population was predominantly female (55.9%) with an overall mean age of 39.1 ± 11.0 (range 17 to 66) years. The ethnic distribution of Chinese: Malays: Indians: Others was in a ratio of 6.0: 3.6: 4.9: 1.0. The mean body weight and mean BMI were ± 27.3 (range 70 to 236) kg, and ± 8.39 (range 30.0 to 82.0) kg/m2 respectively. Laparoscopic sleeve gastrectomy was performed as a primary procedure in 624 patients (97.35%). Of the 17 (2.65%) patients who underwent sleeve gastrectomies as a revision procedure, 16 previously had an adjustable gastric band, with 5 suffering from band related complications and 11 with inadequate weight loss. One patient who had previously undergone a sleeve gastrectomy reported inadequate weight loss and was found to have a dilated sleeve on further workup. This patient then underwent a revision sleeve gastrectomy.

5 All except 1 patient had their operation performed successfully in the laparoscopic approach; 1 patient (0.16%) had a conversion to open surgery due to dense adhesions between the posterior stomach wall and the pancreas from previous pancreatitis. Table 1. Patient characteristics and surgical approach N = 641 (%) Mean Age (years) 39.1 ± 11.0 (range 17-66) Female gender 358 (55.9) Ethnic group Chinese Malays Indians Others 250 (39.0) 205 (32.0) 144 (22.5) 42 (6.6) Mean Weight (kg) ± 27.3 (range ) Mean BMI (kg/m 2 ) ± 8.39 (range ) LSG as primary bariatric 624 (97.35) procedure Conversion to open approach 1 (0.16) Six hundred and thirty patients were followed up for at least 30 days; the 30-day default rate was 1.72%. There was 1 (0.16%) early mortality which occurred on post-operative day 6 due to pulmonary embolism (table2). The overall 30-day morbidity rate was 3.49%, with 7 leaks (1.11%), 2 strictures (0.32%), 4 haemorrhages (0.63%), 4 wound infections (0.63%), 5 others (0.63%; including the 1 mortality from a pulmonary embolism). All 7 patients with leaks developed staple line leaks at the angle of His. Six were acute leaks 15 occurring within 7 days of the initial surgery, while 1 was early (occurred on postoperative day 12). All patients underwent surgical lavage and drainage. Both patients with early sleeve stricture required endoscopic balloon dilatation. Of the 4 patients with bleeding complications, 1 had intraluminal bleeding and presented with hematemesis. The other 3 had intra-abdominal bleeding, of which 1 underwent a diagnostic laparoscopy with suture hemostasis of staple line bleeding. The remaining 2 responded well to conservative management. The four patients with wound infection all developed superficial wound infection at the site of retrieval of the greater curve of the stomach. All recovered well without surgical intervention. Two patients (0.32%) had delayed small bowel perforations, likely due to inadvertent bowel injury during the bariatric procedure. Both underwent surgical repair of the injury. One patient had no passage of contrast on a routine postop day 1 fluoroscopic study. This patient then underwent a relook laparoscopy which showed rotation and kinking of the sleeve due to an ill-placed anchoring suture to the greater omentum. The offending suture was released and gastropexy to the greater omentum to straighten out the sleeve was performed with resolution of symptom. Another patient developed vomiting on postoperative day 1 and a contrast study showed herniation of the gastric sleeve into the thorax. This patient had a relook laparoscopy, reduction of the migrated sleeve, and gastropexy to the pancreatic capsule. Overall, 12 patients (1.90%) underwent reoperation for complications within the 30-day postoperative period.

6 Table 2. Adverse Outcomes within 30-days after Surgery Outcome N = 630 (%) Mortality 1 (0.16) Overall Morbidity 22 (3.49) Staple line leak 7 (1.11) Hemorrhage 4 (0.63) Stricture 2 (0.32) Wound infection 4 (0.63) Others Delayed small bowel perforation 2 (0.32) Herniated sleeve 1 (0.16) Kinked sleeve 1 (0.16) Pulmonary embolism 1 (0.16) Reoperations 12 (1.90) Late mortality and morbidity rates were calculated for 543 patients who reached at least a 1-year post-operative follow up (table 3). Of this group, 134 patients (24.68%) were lost to follow up and were excluded from analysis. There were no late mortalities in this group of patients. There was 1 late leak (0.24%) which occurred at 9 weeks post-surgery and the patient underwent laparoscopic lavage and drainage, creation of a feeding jejunostomy and subsequently had a stent placement to exclude the leak. Another 2 patients (0.49%) developed strictures of their gastric sleeve at 5 weeks and 10 months respectively, and both underwent endoscopic balloon dilatation. 19 patients (4.65%) reported gastroesophageal reflux (GERD) symptoms 16 of heartburn and/or regurgitation; 2 underwent gastroscopy and were found to have erosive oesophagitis. All were treated medically with proton pump inhibitors with good response. One patient developed dysphagia and reflux symptoms and was eventually found to have achalasia on high resolution manometry studies; she received a laparoscopic Heller s cardiomyotomy and Roux-en-Y gastric bypass procedure more than 1 year after her initial sleeve gastrectomy. Another patient developed an incisional hernia (0.24%) and underwent surgical repair. The overall late morbidity rate was 5.87% Table 3. Adverse Outcomes within 1-year after Surgery Outcome N = 409 (%) Mortality 0 Overall late morbidity 24 (5.87) Staple line leak 1 (0.24) Stricture 2 (0.49) Gastroesophageal reflux 19 (4.65) Achalasia 1 (0.24) Incisional hernia 1 (0.24) From the above results, our overall mortality and morbidity rates were 0.16% and 9.36% respectively.

7 Discussion This first national safety audit of laparoscopic sleeve gastrectomy showed a low rate of mortality and morbidity both in the early 30-day period and at the late 1-year follow up. As with any multi-centre study, differences in surgeon experience and variations in technique are to be expected. However, the pooled data shows that this procedure has a good safety profile in Singapore. We compared these results to safety data from the Fourth International Consensus Summit on Sleeve Gastrectomy, as well as other Asian centres (table 4). Our mortality and morbidity rates would seem to fall within the ranges reported. The wide range of reported morbidity rates in the literature is most likely due to a lack of consensus in the reporting of complications as well as the great variation in the length of follow-up. Our study reported both specific complications pertinent to the sleeve procedure such as leaks, strictures and bleeding, as well as general complications such as wound infections and incisional hernias. We further reported the incidence of gastroesophageal reflux (GERD) symptoms at 1 year post-lsg. The rate of de novo GERD post laparoscopic sleeve gastrectomy in Asians has not been established, with only 1 report from Prasad et al 19 at 1.8%. In our series, the rate of de novo GERD symptoms was 4.65%, which is approximately half of the reported international figure (7.9%), 15 although we acknowledge that in our audit GERD symptoms were self-reported and not actively investigated.

8 Table 4. Summary of complication rates internationally and in Asian centres Author, centre Gagner 17, Internation al survey Moon 18, Korea Kasama 19, Japan Chowbey 20, India Prasad 21, India Lakdawala 22, India Mui 23, Hong Kong Ser 24, Taiwan Zachariah 25, Taiwan Yang 26, China Study period 4.9 ± 2.7 years Jan May 2004 Feb Jan 2008 Nov Feb 2009 Mar Mar 2011 Oct Mar 2008 May Nov 2007 Jan Feb 2009 Feb Mar 2012 Jan Oct 2010 N Mean age (yr) Mean BMI (kg/m 2 ) Follow-up period Conversion to open (%) Mortality (%) Morbidity (%) Significant complications N (%) NS NS NS 0.2 ± ± 1.6 Overall 22.7 Leak 1.3% Hemorrhage 1.8% Stricture 0.9% GERD 7.9% (16-62) 37.2 ( ) ± ± 12 Minimum 3 months 30 days Overall 3.8 Major Overall 17.4 Major (19 67) 58.0 ( ) Minimum 6 months Overall 6.7 Major ± ± months 0 0 Overall 16.7 (15 62) (33 68) Major Median 38 Median 46 1 year NS 0 Overall 4% (19-72) (30-85) Major 2% ± ± 7.8 Mean 7.1 ± 0 0 Overall 7.2 (18 65) ( ) 5.0 months Major ± ± years 0 0 Overall 11.9 Major ±10.1 (18 62) ± 9.7 (18-55) 37.4 ± 4.8 ( ) 46.1 ± 11.5 ( ) Up to 5 yrs Overall 4.4 Major year 5 0 Overall 30 Major 0 1 leak (0.7%) 1 hemorrhage (0.7%) 1 leak (4.3%) 1 hemorrhage (4.3%) 1 stricture (4.3%) 1 peritonitis (4.3%) 4 hemorrhage (5.3%) 1.8% GERD 1 leak (2%) 1 leak (1.48%) 1 stricture (1.45) 4 leaks (3.4%) 2 hemorrhage (1.7%) 1 stricture (0.9%) 3 leaks (1.3%) 3 strictures (1.3%) 1 peritonitis (0.4%) 0 Shen 27, China NS not stated Jan 2011 Nov ± ± 6.3 Mean 1.5 months (7-17) 0 0 Overall 5 Major 5 1 stricture (5%)

9 Our audit faced the usual limitations of a multicentre study. A number of patients defaulted follow-up even at 1 year (24.7%). It is unknown whether this group of patients were more likely to develop complications and how they might affect our results. This study audited all 6 public institutions, but does not include data from the private sector clinics and hospitals in Singapore. Weight-loss and metabolic outcomes were not examined in this study. Finally, we did not report on nutritional complications, which tend to manifest after 1-2 years. Conclusion Laparoscopic sleeve gastrectomy has a good safety profile in Singapore, with low morbidity and mortality rates. Disclosure There are no financial disclosures or conflicts of interest.

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