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

St. Luke's-Roosevelt Hospital Center

Status: Completed

Conditions: Morbid Obesity

Treatments: Procedure: Laparoscopic gastric banding

Study type: Interventional

Funder types: Other

Identifiers

NCT01039077

SLR IRB#08-148

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI > 40
• ASA Class I or II

Exclusion criteria

• Comorbid cardiac, pulmonary, renal, hepatic disease
• Bleeding disorder
• Previous gastric/esophageal surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Single incision laparoscopic gastric banding

Active Comparator group

Description:

Patients in this group will undergo laparoscopic gastric banding through a single periumbilical incision.

Treatment:

Procedure: Laparoscopic gastric banding

Five port laparoscopic gastric banding

Active Comparator group

Description:

Patients in this group will undergo conventional laparoscopic gastric banding using 5 small incisions.

Treatment:

Procedure: Laparoscopic gastric banding