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

Sponsor
Imperial College London (Other)
Overall Status
Completed
CT.gov ID
NCT05146011
Collaborator
(none)
155
Enrollment
228
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Gatsric balloon insertion

Study Design

Study Type:
Observational
Actual Enrollment :
155 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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'
Actual Study Start Date :
Jun 1, 2000
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Imperial College London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matyas Fehervari, Honorary Clinical Research Fellow, Imperial College London
ClinicalTrials.gov Identifier:
NCT05146011
Other Study ID Numbers:
  • PCD906
First Posted:
Dec 6, 2021
Last Update Posted:
Dec 6, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Obesity
Obesity, Morbid

Study Results

No Results Posted as of Dec 6, 2021