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NCT01183273 · ClinicalTrials.gov registry record · NA
Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass
A NA study of Obesity, sponsored by Suzanne J. Rose.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01183273: Completed NA study of Obesity, sponsored by Suzanne J. Rose.
NCT01183273 is a NA study of Obesity that has completed, run by Suzanne J. Rose. The registered enrollment target is 50 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01183273, a NA study of Obesity, has completed, sponsored by Suzanne J. Rose.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Background Laparoscopy is the preferred surgical approach for a number of different diseases as it allows for diagnosis and treatment in the setting of a safe and feasible method offering enhanced cosmesis. The natural evolution of laparoscopy is micro-laparoscopy which utilizes smaller instruments and optics. Technological advancements have enabled miniaturization of the surgical equipment without compromising diagnostic or operative capabilities. Dr. Keith Zuccala is currently performing micro-laparoscopic gastric bypass with an identical safety profile as traditional laparoscopy (NSQIP data comparison between Dr. Laura Choi and Dr. Keith Zuccala). The current trend in laparoscopy is to minimize incisions and their size to decrease trauma to the abdominal wall. Study Design Both methods have never been compared in a prospective randomized trial to address the following questions. 1. Is there a difference in outcome? 2. Is there a decrease in postoperative pain? 3. Does it decrease time off from work? 4. Does micro-laparoscopy increase OR time? 5. What is the effect on cost of micro-laparoscopy? Patients will be randomized to one or the other method, disclosing that to the investigators best knowledge both methods are equally safe and that Dr. Zuccala has performed several hundred cases using both methods. Patient Population Projected sample size would be 50 patients in each group. Accrual should be feasible over the course of 9-12 months. Data collection (patients will be followed for a total of 30 days for the purpose of this study) 1. NSQIP data to assess outcome 2. Postoperative usage of pain medication while in the hospital 3. Time off from work 4. OR time 5. Direct cost of procedure as it relates to material used
Conditions Studied
Interventions
- PROCEDURE Laparoscopic Surgery
- PROCEDURE Microlaparoscopic gastric bypass
Study Locations (1)
Connecticut
- Danbury Hospital - Danbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01183273
The ClinicalTrials.gov registry entry for NCT01183273 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (94% lower). The listed sponsor is Suzanne J. Rose, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Laparoscopic Surgery is the first listed.
NCT01183273 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT01183273 about?
NCT01183273 is a clinical study titled "Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass". Background Laparoscopy is the preferred surgical approach for a number of different diseases as it allows for diagnosis and treatment in the setting of a safe and feasible method offering enhanced cosmesis. The natural evolution of laparoscopy is micro-laparoscopy which utilizes smaller instruments ...
What is the current status of trial NCT01183273?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2010-03. Estimated completion is 2014-07.
What conditions does trial NCT01183273 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT01183273?
The interventions under investigation include: Laparoscopic Surgery (PROCEDURE), Microlaparoscopic gastric bypass (PROCEDURE).
Who is sponsoring clinical trial NCT01183273?
This trial is sponsored by Suzanne J. Rose, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01183273 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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