IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss (IIWL)
This study has been completed.
Sponsor:
University of California, San Francisco
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01040377
First received: December 23, 2009
Last updated: December 28, 2009
Last verified: October 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 inadequate initial weight loss.
| Condition |
|---|
| Inadequate Initial Weight Loss Persistent Clinically Severe Obesity |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss After Gastric Bypass: Intermediate Results |
Resource links provided by NLM:
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 ]
- Comorbidity status [ Time Frame: throughout follow-up ]
- Health-related Quality of Life (HR-QoL) [ Time Frame: at last follow-up ]
- Subjective satisfaction [ Time Frame: at the last follow-up ]
- Morbidity and mortality [ Time Frame: throughout follow-up ]
Secondary Outcome Measures:
- Failure/success rate [ Time Frame: at yearly intervals throughout follow-up ]
- Metabolic and nutritional variables [ Time Frame: throughout follow-up ]
| Enrollment: | 42 |
| 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 |
|---|
| Inadequate initial weight loss 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 Inadequate Initial Weight Loss after failed Roux-en-Y gastric bypass(RYGB).
Eligibility| 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 that underwent laparoscopic revision gastric bypass after previously failed Roux-en-Y gastric bypass "RYGB" with an Inadequate initial weight loss "IIWL" pattern.
Criteria
Inclusion Criteria:
- laparoscopic revisional RYGB for failed RYGB with IIWL or non-responders pattern
Exclusion Criteria:
- failed RYGB with a WR 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 program
- missing records and/or unreachable patients with scan information for analysis
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040377
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040377
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 Franisco |
| 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 of Metabolic and Bariatric Surgery.
Mouiel J, Bourg S, Iannelli A, et al. Nouvelle technique de gastroplatie verticale calibree type Mason-MacLean avec cure 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, University of California San Francisco, UCSF Fresno / ALSA Medical Group, Inc. Minimally Invasive Surgery Program |
| ClinicalTrials.gov Identifier: | NCT01040377 History of Changes |
| Other Study ID Numbers: |
CMC IRB No. 2009077 U1111-1113-0264 ( Other Identifier: World Health Organization, Universal Trial Number ) |
| Study First Received: | December 23, 2009 |
| Last Updated: | December 28, 2009 |
Keywords provided by University of California, San Francisco:
|
Inadequate Initial Weight Loss Inadequate weight loss Poor weight loss Failed gastric bypass Revision gastric bypass |
Additional relevant MeSH terms:
|
Body Weight Weight Loss Obesity, Morbid Signs and Symptoms Body Weight Changes |
Obesity Overnutrition Nutrition Disorders Overweight |
ClinicalTrials.gov processed this record on June 23, 2017