Laparoscopic Revision Gastric Bypass for Weight Recidivism

NCT01040572 | Completed DMC

• 2 other identifiers: CMC IRB No. 2009078U1111-1113-0216
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Weight Regain; Weight Recidivism; Obesity Recidivism; Clinically Severe Obesity

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Weight loss expressed as Body Mass Index and Percentage Excess Weight Loss

  At the lowest weight loss point and at last follow-up

• Comorbidity status

  throughout follow-up

• Subjective Satisfaction

  at last follow-up

• Health-Related Quality of Life (HR-QoL).

  at the last follow-up

• Morbidity and mortality

  throughout follow-up

Secondary Outcomes (2)

• To assess failures

  at yearly intervals throughout follow-up

• To evaluate the patients´ metabolic and nutritional status

  throughout follow-up

Study Arms (1)

Obesity recidivism after gastric bypass

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with previously failed Roux-en-Y gastric bypass "RYGB" surgery with a weight recidivism pattern.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Fresno Center for Medical Education and Research

Fresno, California, 93701, United States

Location

Related Publications (59)

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  BACKGROUND

Related Links

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

Study Officials

• Francisco M Tercero, MD

  Research Associate, University of California San Francisco

  STUDY DIRECTOR

• Kelvin D Higa, MD

  Professor of Surgery, University of California San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 29, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 29, 2009

Record last verified: 2009-10

Locations

US (1)