Clinical Outcomes of Single Stage Versus Two-stage Treatment of Severe Obesity
November 23, 2021 updated by: Matyas Fehervari, Imperial College London
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
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
155
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Single stage pathway
|
Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery
|
|
Two stage pathway
|
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
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. |
24 months after Bariatric Surgery
|
|
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.
|
90 days following gastric bypass surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.