Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding

Morbid Obesity Clinical Trial

Official title:

Single Incision Laparoscopic Gastric Banding Versus Conventional Five Port Laparoscopic Gastric Banding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039077
• Other study ID #: SLR IRB#08-148
• Status: Completed
• Phase: N/A
• First received: December 22, 2009
• Last updated: August 5, 2015
• Start date: December 2009
• Est. completion date: October 2012

Study information

• Verified date: August 2015
• 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI > 40

• ASA Class 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

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopic gastric banding
Laparoscopic gastric banding for the treatment of morbid obesity.

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 post-operative	No
Secondary	quality of life		1 week and 3 months post-operative	No
Secondary	perioperative complication rate		1 month	Yes