Text Size

Laparoscopic Revision Gastric Bypass for Weight Recidivism (WR)

This study has been completed.
Sponsor:
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01040572
First received: December 23, 2009
Last updated: December 26, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition
Weight Regain
Weight Recidivism
Obesity Recidivism
Clinically Severe Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laparoscopic Revision Gastric Bypass Surgery for Weight Recidivism: Our Experience in 170 Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Comorbidity status [ Time Frame: throughout follow-up ] [ Designated as safety issue: No ]
  • Subjective Satisfaction [ Time Frame: at last follow-up ] [ Designated as safety issue: No ]
  • Health-Related Quality of Life (HR-QoL). [ Time Frame: at the last follow-up ] [ Designated as safety issue: No ]
  • Morbidity and mortality [ Time Frame: throughout follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess failures [ Time Frame: at yearly intervals throughout follow-up ] [ Designated as safety issue: No ]
  • To evaluate the patients´ metabolic and nutritional status [ Time Frame: throughout follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 132
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obesity recidivism after gastric bypass

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040572

Locations
United States, California
UCSF Fresno Center for Medical Education and Research
Fresno, California, United States, 93701
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Director: Francisco M Tercero, MD Research Associate, University of California San Francisco
Principal Investigator: Kelvin D Higa, MD Professor of Surgery, University of California San Francisco
  More Information

Additional Information:
"Click here for more information about the department sponsor´s web site"  This link exits the ClinicalTrials.gov site

Publications:
Mouiel J, Bourg S, Iannelli A, et al. Nouvelle technique de gastroplatie verticale calibree type Mason-MacLean aveccure de reflux gastro-oesophagien. Jornal de Coelio Chirurgie 2001; 38: 53-6.
Majani G, Pierobon A, Giardini A, et al. Satisfaction Profile (SAT-P) in 732 patients: focus on subjectivity in HRQoL assessment. Psychol Health 2000;15:409-22.

Responsible Party: Kelvin D. Higa, MD; FACS; FASMBS; Clinical Professor of Surgery, UCSF, UCSF Fresno / ALSA Medical Group, Inc. Minimally Invasive Surgery Program
ClinicalTrials.gov Identifier: NCT01040572     History of Changes
Other Study ID Numbers: CMC IRB No. 2009078, U1111-1113-0216
Study First Received: December 23, 2009
Last Updated: December 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Obesity recidivism
Weight Regain
Weight recidivism
Morbidity
Complication
 Late complications
Revisional gastric bypass
Re-operative gastric bypass
Revisional bariatric surgery
Re-operative bariatric surgery

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013