Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss (IIWL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01040377
Recruitment Status : Completed
First Posted : December 29, 2009
Last Update Posted : December 29, 2009
Sponsor:
Information provided by:
University of California, San Francisco

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 inadequate initial weight loss.

Condition or disease
Inadequate Initial Weight Loss Persistent 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 Inadequate Initial Weight Loss after failed Roux-en-Y gastric bypass(RYGB).
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laparoscopic Revision Gastric Bypass for Inadequate Initial Weight Loss After Gastric Bypass: Intermediate Results
Study Start Date : October 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Inadequate initial weight loss after gastric bypass


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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. Health-related Quality of Life (HR-QoL) [ Time Frame: at last follow-up ]
  4. Subjective satisfaction [ Time Frame: at the last follow-up ]
  5. Morbidity and mortality [ Time Frame: throughout follow-up ]

Secondary Outcome Measures :
  1. Failure/success rate [ Time Frame: at yearly intervals throughout follow-up ]
  2. Metabolic and nutritional variables [ Time Frame: throughout follow-up ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01040377


Locations
Layout table for location information
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
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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.
Parej JC, Pilla VF, Callejas-Neto F, et al. Gastroplastia reductora com bypass gastrojejunal em Y-de-roux: conversao para bypass gastrointestinal distal por perdida insuficiente de peso - experiencia em 41 pacientes. Art Gatroenterol 20054; 42(4): 196-200.
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.

Layout table for additonal information
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    
Other Study ID Numbers: CMC IRB No. 2009077
U1111-1113-0264 ( 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:
Inadequate Initial Weight Loss
Inadequate weight loss
Poor weight loss
Failed gastric bypass
Revision gastric bypass
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity, Morbid
Body Weight
Weight Loss
Body Weight Changes
 Obesity
Overnutrition
Nutrition Disorders
Overweight