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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01401426
• Other study ID #: NCT01401426
• Status: Withdrawn
• Phase: N/A
• First received: July 21, 2011
• Last updated: May 18, 2016
• Start date: July 2010
• Est. completion date: September 2010

Study information

• Verified date: May 2016
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• BMI >40

• ASA I or II

Exclusion Criteria:

• Comorbid cardiac, pulmonary, renal, hepatic disease

• Bleeding disorder

• Previous gastric/esophageal surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Nutrition Disorders
• Obesity

Intervention

Procedure:
• Laparoscopic vertical sleeve gastrectomy
Laparoscopic vertical sleeve gastrectomy for the treatment of morbid obesity.
• Laparoscopic vertical sleeve gastrectomy
Laparoscopic vertical sleeve gastrectomy

Locations

Country	Name	City	State
United States	St. Luke's Roosevelt Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss		1 month and 1 year	No
Secondary	Quality of life		1 week and 3 months	No
Secondary	Peri-Operative Complications		1 month	Yes