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

NCT ID: NCT05146011

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-06-30

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity, Morbid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Single stage pathway

Gatsric balloon insertion

Intervention Type PROCEDURE

Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery

Two stage pathway

Gatsric balloon insertion

Intervention Type PROCEDURE

Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery

Interventions

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Gatsric balloon insertion

Insertion of Gastric balloon prior to laparoscopic gastric bypass surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Matyas Fehervari

Honorary Clinical Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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PCD906

Identifier Type: -

Identifier Source: org_study_id