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NCT00247377 · ClinicalTrials.gov registry record · NA
Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity
A NA study of Morbid Obesity, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 197
- Enrollment target
- 1
- Study location
NCT00247377 is a NA study of Morbid Obesity that has completed, run by University of California, Irvine. The registered enrollment target is 197 participants, above the 114-participant average among 24 other Morbid Obesity trials with a reported enrollment target (73% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00247377, a NA study of Morbid Obesity, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 197 participants
- Enrollment target
- 1
- Study location
Study Summary
PURPOSE Obesity is a growing problem in the United States. Severe obesity, known as "morbid obesity", is defined as being 100 pounds in excess of ideal body weight. Nonsurgical treatments for morbid obesity include exercise, dietary restriction, behavior modification, and pharmacological intervention. However, it is estimated that most patients undergoing nonsurgical treatments for weight reduction will regain their weight within 2 to 4 years after treatment. According to the NIH consensus conference in 1991, surgery remains the only effective sustained weight loss treatment for morbid obesity. The Roux-en-Y gastric bypass (GBP) is currently considered the gold standard bariatric surgical operation. Mean weight loss following GBP is approximately 65% of the excess body weight during the first 12 to 18 months postoperatively. Long-term weight loss is in the range of 55-70% of excess body weight loss. Recently, the laparoscopic approach to GBP was reported. Wittgrove and colleagues reported their results of 75 patients who underwent laparoscopic GBP and demonstrated significant short-term advantages with comparable weight loss and reversal of comorbidities compared to the open approach. However, GBP might it be done laparoscopic or open approach can potentially be associated with significant morbidity and mortality such as anastomotic leak, pulmonary embolism, bowel obstruction, and postoperative stricture. The FDA recently approved the laparoscopic adjustable banding system (LAP-BAND) for use in the United States in June 2001. The LAP-BAND system is a device designed to induce weight loss in severely obese patients. It is surgically placed around the proximal stomach to create a small proximal stomach pouch and restricted opening, or stoma, through which passage of food will be slowed. An inflatable portion along the inner aspect of the band is connected to an access port, placed intramuscularly. This enabled stoma adjustments to be made without the need for furthe
Conditions Studied
Interventions
- PROCEDURE Gastric bypass surgery
- PROCEDURE Lap-Band
Study Locations (1)
California
- Univeristy of California, Irvine, Medical Center - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2002-10 |
| Est. Completion | 2009-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00247377
The ClinicalTrials.gov registry entry for NCT00247377 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 197 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 114-participant average among 24 other Morbid Obesity trials with a reported enrollment target (73% higher). The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Morbid Obesity appearing as the primary indexed condition, and to 2 interventions - of which Gastric bypass surgery is the first listed.
NCT00247377 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00247377 about?
NCT00247377 is a clinical study titled "Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity". PURPOSE Obesity is a growing problem in the United States. Severe obesity, known as "morbid obesity", is defined as being 100 pounds in excess of ideal body weight. Nonsurgical treatments for morbid obesity include exercise, dietary restriction, behavior modification, and pharmacological interventio...
What is the current status of trial NCT00247377?
This trial is currently completed. It is a NA study. The enrollment target is 197 participants. The study started on 2002-10. Estimated completion is 2009-12.
What conditions does trial NCT00247377 study?
This clinical trial studies the following conditions: Morbid Obesity.
What interventions are being tested in trial NCT00247377?
The interventions under investigation include: Gastric bypass surgery (PROCEDURE), Lap-Band (PROCEDURE).
Who is sponsoring clinical trial NCT00247377?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00247377 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.