Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery

Not Applicable

Withdrawn

• Conditions: Obesity; Nutrition Disorders; Body Weight
• Interventions: Procedure: Laparoscopic vertical sleeve gastrectomy

• Registration Number: NCT01401426
• Lead Sponsor: St. Luke's-Roosevelt Hospital Center

Brief Summary

Vertical Sleeve Gastrectomy 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. The investigators 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

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• BMI >40
• ASA 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 vertical sleeve gastrectomy	Laparoscopic vertical sleeve gastrectomy	Patients in this group will undergo conventional laparoscopic vertical sleeve gastrectomy using 5 small incisions.
Single incision laparoscopic vertical sleeve gastrectomy	Laparoscopic vertical sleeve gastrectomy	Active Comparator Patients in this group will undergo laparoscopic vertical sleeve gastrectomy through a single periumbilical incision.

Primary Outcome Measures

Name	Time	Method
Weight Loss	1 month and 1 year

Secondary Outcome Measures

Name	Time	Method
Quality of life	1 week and 3 months
Peri-Operative Complications	1 month

Trial Locations

Locations (1)

St. Luke's Roosevelt Hospital Center; 🇺🇸 New York, New York, United States