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

Obesity, Morbid Clinical Trial

Official title:

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'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05146011
• Other study ID #: PCD906
• Status: Completed
• Start date: June 2000
• Est. completion date: June 2019

Study information

• Verified date: November 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Gatsric balloon insertion
Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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