Laparoscopic Revision Gastric Bypass for Weight Recidivism

NCT ID: NCT01040572

Last Updated: 2009-12-29

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

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-12-31

Brief Summary

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The main aim of this study is to analyze and report traditional, patient-centered, and composite intermediate-term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism.

Detailed Description

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There is lack of standardization of primary and revisional bariatric surgery compounded by a scant long-term outcome data. The treatment of inadequate weight loss, weight recidivism, and most severe technical complications after primary bariatric surgery remains refractory to non-operative treatment. Failure rates have been reported up to 20% and 35% for the morbidly obese (MO) and super obese (SO), respectively at 2 to 3 years after surgery. The indication for further surgical intervention remains controversial, as does what type of revisional procedure, both operative and endoscopic, to recommend. Furthermore, there is no standardization of the limb lengths, pouch size or the use of prosthetic reinforcement. Therefore the approach to these patients must be as individualized as their original operations. We formally analyze our experience with all laparoscopic revisional strategies for weigh regain after failed gastric bypass.

Conditions

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Weight Regain Weight Recidivism Obesity Recidivism Clinically Severe Obesity

Keywords

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Obesity recidivism Weight Regain Weight recidivism Morbidity Complication Late complications Revisional gastric bypass Re-operative gastric bypass Revisional bariatric surgery Re-operative bariatric surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Obesity recidivism after gastric bypass

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients that underwent laparoscopic revisional "RYGB" for failed "RYGB" with weight recidivism or weight regain "WR" pattern

Exclusion Criteria

* failed RYGB with an Inadequate Initial Weight Loss "IIWL" pattern
* patients with prior major bariatric conversion or esophago-gastric surgeries
* RYGB patients revised by an open surgical approach
* RYGB patients who underwent laparoscopic revisional RYGB surgery somewhere else and continue their follow-up care with our program
* missing records and/or unreachable patients with scant information for analysis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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UCSF Fresno / ALSA Medical Group, Inc. Minimally Invasive Surgery Program

Principal Investigators

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Francisco M Tercero, MD

Role: STUDY_DIRECTOR

Research Associate, University of California San Francisco

Kelvin D Higa, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Surgery, University of California San Francisco

Locations

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UCSF Fresno Center for Medical Education and Research

Fresno, California, United States

Site Status

Countries

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United States

References

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Related Links

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http://www.fresno.ucsf.edu/surgery

"Click here for more information about the department sponsor“s web site"

Other Identifiers

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U1111-1113-0216

Identifier Type: OTHER

Identifier Source: secondary_id

CMC IRB No. 2009078

Identifier Type: -

Identifier Source: org_study_id