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Completed

NCT Number: NCT01040572

Laparoscopic Revision Gastric Bypass for Weight Recidivism

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.

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Key information

Conditions

Weight Regain Clinically Severe Obesity Obesity Recidivism Weight Recidivism

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Fresno Center for Medical Education and Research

Fresno, California, 93701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Weight loss expressed as Body Mass Index and Percentage Excess Weight Loss

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

  2. Comorbidity status

    Time frame: throughout follow-up

  3. Subjective Satisfaction

    Time frame: at last follow-up

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

    Time frame: at the last follow-up

  5. Morbidity and mortality

    Time frame: throughout follow-up

Secondary outcomes

  1. To assess failures

    Time frame: at yearly intervals throughout follow-up

  2. To evaluate the patients´ metabolic and nutritional status

    Time frame: throughout follow-up

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Laparoscopic Revision Gastric Bypass Surgery for Weight Recidivism: Our Experience in 170 Patients

Acronym: WR

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 29, 2009
Registry last updated
Dec 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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