30-Days Post-Operative Complications in Bariatric Surgery

Not Applicable

Completed

• Conditions: Bariatric Surgery
• Interventions: Procedure: Comparison of two Techniques of bariatric surgery

• Registration Number: NCT04779723
• Lead Sponsor: Multan Medical And Dental College

Brief Summary

comparison of 30-days post-operative outcomes of laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB)

Detailed Description

Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan. Half of the people in this world consider themselves overweight or obese. Obesity is one of the most challenging chronic diseases in the western world as well as in Pakistan . Half of the people in this world consider themselves overweight or obese. Obesity is challenging to control by medical therapy and drug treatment. The most effective way to treat obesity is bariatric surgery. Laparoscopic Roux-en-Y gastric bypass (LRYGB) is a "gold standard" bariatric surgical procedure. Recently there is much attention gained by laparoscopic sleeve gastrectomy (LSG). Therefore, we decided to conduct this comparative study to compare the early post-op complications of LSG with LRYGB technique in patients undergoing bariatric surgery.

Study Timeline

• Study Start: 2018-06-13
• Primary Completion: 2019-02-12
• Study Completion: 2019-10-12
• Status Verified: 2021-02
• Study First Submitted: 2021-02-07
• Study First Submitted QC: 2021-02-27
• Last Update Submitted: 2021-02-27
• Study First Posted: 2021-03-03
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• patients of age 18 to 65 years
• body mass index (BMI) >35 kg/m2 (Morbidly obese)
• Patients with failed conservative treatment of weight control

Exclusion Criteria

• Severe indicative gastroesophageal reflux disease (GERD)
• Conversion of another bariatric procedure
• Large hiatal hernia
• Patients with inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LSG Procedure	Comparison of two Techniques of bariatric surgery	35 Fr bougie was used for the calibration of a gastric tube. 3 to 6 cm of longitudinal incision of the stomach was done at pylorus to the angle of His. Using of absorbable suture, the staple line was sewn.
LRYGB Procedure	Comparison of two Techniques of bariatric surgery	LRYGB technique was performed by placing 4 to 6 trocars, a 150 cm ante-colic Roux-limb gastric pouch (30 to 50 ml) was created with linear stapled or circular stapled gastro-jejunostomy, a 50-cm long biliopancreatic limb was chosen. A passive drainage was kept near to the gastro-jejunostomy.

Primary Outcome Measures

Name	Time	Method
Frequency of Bleeding in Each Study Arm	24 hours after surgery	Patients were examined postoperative for the presence of bleeding
Number of Infections in Each Study Arm	30 days	Patients were examined on postoperative 30 days for the presence of Wound infections
Mortality in Each Study Arm	30 days	Patients were followed for 30 days and number of mortalities was noted on each arm
Frequency of Anastomotic Leakage in Each Study Arm	within the first 30 days after surgery	Patients were examined on postoperative 30 days for the presence of Anastomotic leakage

Secondary Outcome Measures

Name	Time	Method
Hospital Stay	30 days	Duration of hospitalization

Trial Locations

Locations (1)

Multan Medical and Dental College; 🇵🇰 Multan, Punjab, Pakistan