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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05146011
Other study ID # PCD906
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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