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NCT01040481 · ClinicalTrials.gov registry record

Adding Malabsorption for Failed Gastric Bypass

A clinical trial, sponsored by University of California, San Francisco.

Completed
Registry status
19
Enrollment target

NCT01040481: Completed study, sponsored by University of California, San Francisco.

NCT01040481 is a clinical trial that has completed, run by University of California, San Francisco. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01040481 has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
19 participants
Enrollment target

Study Summary

The main aim of this study is to analyze and report the preliminary and intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism. 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; and 3) Patient satisfaction and Health-Related Quality of Life "HR-QoL" measured by a standardized, non-validated subjective satisfaction questionnaire and the validated, disease-specific, Moorehead-Ardelt II QoL questionnaires, respectively; 4) Morbidity \& Mortality including nutritional status and metabolic complications. Consequently, secondary objectives of this study are 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 assessing preliminary and intermediate results after the surgery under analysis. 2) To evaluate the metabolic and nutritional status by measurements of particular clinical and biochemical parameters. This research is in line with the most current provocative new ideas and recent high impact publications. To the best of our knowledge, this is the very first outcome study of revisional malabsorptive distal gastric bypass surgery by laparoscopy with diverse revisional strategies such as revisional gastroplasty, revisional Fobi-Capella, revisional Adjustable Gastric Band, conversion to distal, and conversion to very, very long limb gastric bypass. Previously, several studies have addressed conversion to malabsorptive gastric bypass after a failed primary proximal gastric bypass but none has addressed the failed distal gastric bypass nor the adequate balance between increasing restriction and malabsorption for decreasing the risk of protein-calorie malnutrition.

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2009-08
Est. Completion 2009-12

What the finished NCT01040481 record still lists

NCT01040481 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01040481 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01040481 about?

NCT01040481 is a clinical study titled "Adding Malabsorption for Failed Gastric Bypass". The main aim of this study is to analyze and report the preliminary and intermediate term outcomes after laparoscopic revision Roux-en-Y gastric bypass surgery for weight recidivism. The foremost outcome measurements are 1) Fat loss mainly measured as weight loss and expressed as trends in BMI, %EWL...

What is the current status of trial NCT01040481?

This trial is currently completed. The enrollment target is 19 participants. The study started on 2009-08. Estimated completion is 2009-12.

Who is sponsoring clinical trial NCT01040481?

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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Source: ClinicalTrials.gov NCT01040481, the US trial registry maintained by the National Library of Medicine. NCT01040481 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.