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

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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
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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
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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

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Groups and Cohorts
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Group/Cohort
Inadequate initial weight loss after gastric bypass


Outcome Measures
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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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 )
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:
Body Weight
Weight Loss
Obesity, Morbid
Signs and Symptoms
Body Weight Changes
 Obesity
Overnutrition
Nutrition Disorders
Overweight