Clinical Outcomes of Single Stage Versus Two-stage Treatment of Severe Obesity

Completed

• Conditions: Obesity, Morbid
• Interventions: Procedure: Gatsric balloon insertion

• Registration Number: NCT05146011
• Lead Sponsor: Imperial College London

Brief Summary

Laparoscopic Roux-en-Y gastric bypass (LRYGB) in super obese patients (BMI≥50kg/m2) is a challenging operation. Weight reduction with intragastric balloon (IGB) prior to LRYGB may improve operative outcomes and improves weight loss. We assessed 155 patients, with a BMI≥50 kg/m2 who underwent either intra-gastric balloon (IGB) insertion followed by LRYGB (two-stage group), or LRYGB as the definitive bariatric procedure (single-stage group) in our institution. Two stage procedure was adopted for high-risk individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-06
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Status Verified: 2021-11
• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-23
• Last Update Submitted: 2021-11-23
• Study First Posted: 2021-12-06
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• patients, with a BMI≥50 kg/m2, underwent either intra-gastric balloon (IGB) insertion followed by LRYGB (two-stage group), or LRYGB as the definitive bariatric procedure (single-stage group)

Exclusion Criteria

• NA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single stage pathway	Gatsric balloon insertion	-
Two stage pathway	Gatsric balloon insertion	-

Primary Outcome Measures

Name	Time	Method
Percentage of total weight loss measured in kilograms following Bariatric Surgery	24 months after Bariatric Surgery	Percentage total weight loss is the proportion of weight lost in kilograms since the intervention of the weight before the intervention. This will be calculated by using the following formula. Initial weight is considered the weight on the day of surgery and Postop weight considered as the weight 24 months following Bariatric Surgery (intervention).; Percent of total weight loss (%TWL)=((Initial Weight)-(Postop Weight)): Initial Weight x 100; Weight is expressed in kilograms.
Length of hospital stay in days following Bariatric Surgery	90 days following gastric bypass surgery	Hospital stay following laparoscopic gastric bypass surgery measured in days and compared between the groups.