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Laparoscopic Revision Gastric Bypass for Weight Recidivism (WR)

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ClinicalTrials.gov Identifier: NCT01040572
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : December 29, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Weight Regain Weight Recidivism Obesity Recidivism Clinically Severe Obesity

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.

Study Design

Study Type : Observational
Actual Enrollment : 132 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laparoscopic Revision Gastric Bypass Surgery for Weight Recidivism: Our Experience in 170 Patients
Study Start Date : October 2009
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Obesity recidivism after gastric bypass


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
www.asbs.org/htm/Private/resolution.html. American Society for Metabolic and Bariatric Surgery.
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 ( Other Identifier: World Health Organization, Universal Trial Number )
First Posted: December 29, 2009    Key Record Dates
Last Update Posted: December 29, 2009
Last Verified: October 2009

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
Body Weight
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms