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Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass

NCT01183273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-08-22

No results posted yet for this 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

Interventions

PROCEDURE

Microlaparoscopic gastric bypass

microlaparoscopic gastric bypass will be performed using standard of care procedure.

PROCEDURE

Laparoscopic Surgery

laparoscopic gastric bypass will be performed using standard of care procedure.

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    collaborator INDUSTRY

  • Suzanne J. Rose

    lead OTHER

Principal Investigators

  • Pierre Saldinger, M.D. · Danbury Hospital

  • Keith Saldinger, M.D. · Danbury Hospital

  • Suzanne J House, M.S., Ph.D. · Danbury Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01183273 on ClinicalTrials.gov