Status:
COMPLETED
Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass
Lead Sponsor:
Suzanne J. Rose
Collaborating Sponsors:
Ethicon Endo-Surgery
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 cos...
Detailed Description
This study compares two groups of patients who have voluntarily chosen to undergo roux-n-y gastric bypass surgery. The groups will be randomized to receive micro-laparoscopic or laparoscopic surgery t...
Eligibility Criteria
Inclusion
- A body mass index (BMI) ≥ 40 with or without co-morbid conditions\*
- A BMI ≥ 35 with co-morbid conditions\*
- Permanent lifestyle changes including exercise
- No significant, untreated psychiatric illnesses
- Age ≥ 18 years
- Sufficient ability and cognition to understand surgery, potential complications and subsequent associated changes
- Willingness to participate in treatment and long-term follow-up
- Proof of failed attempts at non-surgical weight reduction
- Acceptable medical/operative risks \* Co-morbid solutions include: hypertension, diabetes mellitus, cardiac disease, hypercholesterolemia/hyperlipidemia, sleep apnea, asthma, hypoventilation syndrome of obesity, degenerative joint disease, gastro-esophageal reflux disease, venous stasis ulcers, depression, menstrual irregularities/infertility, polycystic ovary syndrome, fungal skin infections.
Exclusion
- The need to convert from laparoscopic roux-n-y to an open abdominal procedure.
- Patients with congestive heart failure or other serious illness which would prevent the patient from a successful surgery and recovery
- Women who are nursing or pregnant
- Patients who smoke
- Patient's insurance will not cover the cost of surgery.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01183273
Start Date
March 1 2010
End Date
July 1 2014
Last Update
August 22 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Danbury Hospital
Danbury, Connecticut, United States, 06810