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OpenTrials
Completed

NCT Number: NCT05146011

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

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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gatsric balloon insertion

Procedure

Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery

Primary outcomes

  1. Percentage of total weight loss measured in kilograms following Bariatric Surgery

    Time frame: 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.

  2. Length of hospital stay in days following Bariatric Surgery

    Time frame: 90 days following gastric bypass surgery

    Hospital stay following laparoscopic gastric bypass surgery measured in days and compared between the groups.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study 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'

Important dates

Study start
2000
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2021
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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