Sleeve Gastrectomy and Cholecystectomy Are Safe in Obese Patients With Asymptomatic Cholelithiasis: A Multicenter Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Zagazig University
- Enrollment
- 222
- Primary Endpoint
- time of operation
Study Overview
Brief Summary
Introduction:
Obesity is an increasingly serious public health problem on a global level. Gallstones may become symptomatic after sleeve gastrectomy surgery. There is a debate regarding concomitant cholecystectomy during bariatric surgery.
Aim of the study: This study analyzed outcomes of laparoscopic sleeve gastrectomy (LSG) with and without concomitant laparoscopic cholecystectomy in morbid obese patients with gall bladder stones.
Patients and methods: We conducted randomized clinical study on 222 patients. These patients were categorized into two equal groups (111 in each group) .Group A: underwent SG and concomitant laparoscopic cholecystectomy in morbid obese patient with evidence of gall bladder stone, Group B: SG only without concomitant LC inspite of evidence of gall bladder stone. This study was performed at single institution from January 1, 2016 to January 1, 2019.
Detailed Description
The WHO (World Health Organization) has already affirmed that obesity is a universal epidemic that represents one of the substantial present health complications . Bariatric surgery (BS) is the pillar of cure for morbid obesity with thousands of surgeries implemented each year .Bariatric surgery guides patients to waste weight and correct obesity- related troubles, and improves quality of life .Sleeve Gastrectomy (SG) materialized as the first part of a staged duodenal switch step and afterwards changed to be a main restrictive bariatric surgery .The comprehensive pervasiveness of cholelithiasis in the normal populace is 10% to 20%. The pervasiveness of cholelithiasis in patients with severe obesity is 3 to 5 times greater in comparison with that for gangly persons .In obese patients, gallstone is more emlematic than in non-obese people .
Aim of the work, gap statement and strength of the study:
During laparoscopic sleeve gastrectomy for morbid obesity surgery, there is no golden standard of dealing with gall bladder stones, which is generally selected by the surgeon's preferences or by local conditions. For many surgeons, the benefit of routine cholecystectomy in patients with gall bladder stones did not justify an additional risk and the risks of cholecystectomy after a laparoscopic sleeve gastrectomy may be higher due to adhesion and expose patients to another surgery. Others believe that concomitant cholecystectomy may increase operative time, morbidity and decrease fat after laparoscopic sleeve gastrectomy helps good identification of anatomy during later laparoscopic cholecystectomy. In this study, we have designed a randomized clinical trial to compare outcomes in patients who underwent laparoscopic sleeve gastrectomy with or without concomitant laparoscopic cholecystectomy in patients with gall bladder stones (Symptomatic or asymptomatic). The primary aim was to compare the morbidity and mortality rate during and after both techniques. The secondary aim was to evaluate the postoperative body weight. The tertiary aim was to detect the incidence of symptomatic and asymptomatic gall bladder stone in cases with no concomitant laparoscopic cholecystectomy.
- Material and methods
Study design:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and Non pregnant female, >20 years old, All patients were contender for bariatric surgery in conformity with National Institutes of Health consensus criteria for the management of morbid obesity (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with compelling co-morbidities linked to obesity),, had pre-operative ultrasound patients who completed at least two-years follow up
Exclusion Criteria
- •younger than 20 years, History of cholecystectomy, No pre-operative imaging available within 6 months, dearth of interest. Subjective mess and cognitive vulnerability that halt the patient from considering the operation, Drug or alcohol junkie, Patients unsuitable for general anesthesia, preceding bariatric operation, Patients with calcular obstructive jaundice underwent ERCP with stenting and Cases with arduous displaying of right upper quadrant or liver cirrhosis found at surgery.
Outcomes
Primary Outcomes
time of operation
Time Frame: 2 years
time of operation in minutes
hospital length of stay
Time Frame: 2 years
hospital length of stay i days
Secondary Outcomes
- body mass loss(2 years)
Investigators
Tamer Alsaied Alnaimy
assistant professour of general and laparoscopic surgery
Zagazig University