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NCT01041131 · ClinicalTrials.gov registry record
Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass
A clinical trial, sponsored by University of California, San Francisco.
- Completed
- Registry status
- 70
- Enrollment target
NCT01041131 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 70 participants.
The verdict
NCT01041131 has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- 70 participants
- Enrollment target
Study Summary
The main aim of this study is to analyze and report the intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass (RYGB) surgery for failed and/or complicated Vertical Banded Gastroplasty (VBG). The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and expressed as trends in BMI, %EWL, and/or %EBL. 2) Trend in Comorbidity status. 3) Subjective Satisfaction and Health-Related Quality of Life "HR-QoL" are measured by a standardized, non-validated satisfaction questionnaire and by a validated, disease-specific worldwide used HR-QoL questionnaire. 4) Morbidity \& Mortality include nutritional status and metabolic complications. Consequently, secondary objectives of this study are the following. 1) To assess failure rate defined as percentage of excess weight loss \< 50%, lowest BMI \>35 for morbidly obese (MO) or \>40 for superobese (SO), and/or lack of resolution/improvement of major comorbidities at the point in time when assessed at each postoperative year after the surgery under study. 2) To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2009-10 |
| Est. Completion | 2009-12 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01041131
The ClinicalTrials.gov registry entry for NCT01041131 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT01041131 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01041131 about?
NCT01041131 is a clinical study titled "Laparoscopic Revision of Vertical Banded Gastroplasty to Gastric Bypass". The main aim of this study is to analyze and report the intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass (RYGB) surgery for failed and/or complicated Vertical Banded Gastroplasty (VBG). The foremost outcome measurements are 1) Fat loss mainly measured as weight loss an...
What is the current status of trial NCT01041131?
This trial is currently completed. The enrollment target is 70 participants. The study started on 2009-10. Estimated completion is 2009-12.
Who is sponsoring clinical trial NCT01041131?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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