Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding
Not Applicable
Completed
- Conditions
- Morbid Obesity
- Interventions
- Procedure: Laparoscopic gastric banding
- Registration Number
- NCT01039077
- Lead Sponsor
- St. Luke's-Roosevelt Hospital Center
- Brief Summary
Gastric banding has been shown to significantly reduce weight and has been approved as a treatment of morbid obesity. The standard laparoscopic operation requires five small incisions for the introduction of instruments and the band into the patient's abdomen. We have developed a technique for performing this operation through a single incision at the belly button. This study compares this method to the conventional 5-incision approach.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- BMI > 40
- ASA Class I or II
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Exclusion Criteria
- Comorbid cardiac, pulmonary, renal, hepatic disease
- Bleeding disorder
- Previous gastric/esophageal surgery
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Five port laparoscopic gastric banding Laparoscopic gastric banding Patients in this group will undergo conventional laparoscopic gastric banding using 5 small incisions. Single incision laparoscopic gastric banding Laparoscopic gastric banding Patients in this group will undergo laparoscopic gastric banding through a single periumbilical incision.
- Primary Outcome Measures
Name Time Method weight loss 1 month and 1 year post-operative
- Secondary Outcome Measures
Name Time Method perioperative complication rate 1 month quality of life 1 week and 3 months post-operative
Trial Locations
- Locations (1)
St. Luke's-Roosevelt Hospital Center
🇺🇸New York, New York, United States