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

Clinical Outcomes of Single Stage Versus Two-stage Laparoscopic Roux-en-y Gastric Bypass in the Management of Super Obesity: a Propensity Score Weighted Analysis'

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid
• Intervention / Treatment: Procedure: Gatsric balloon insertion

• Study Type: Observational
• Enrollment (Actual): 155

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients, with a BMI≥50 kg/m2 undergoing Bariatric Surgery in Chelsea and Westminster Hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single stage pathway	Procedure: Gatsric balloon insertion; Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery
Two stage pathway	Procedure: Gatsric balloon insertion; Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of total weight loss measured in kilograms following 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.	24 months after Bariatric Surgery
Length of hospital stay in days following Bariatric Surgery	Hospital stay following laparoscopic gastric bypass surgery measured in days and compared between the groups.	90 days following gastric bypass surgery

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2000
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: PCD906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No