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

St. Luke's-Roosevelt Hospital Center

Status: Withdrawn

Conditions: Nutrition Disorders; Obesity; Body Weight

Treatments: Procedure: Laparoscopic vertical sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01401426

NCT01401426

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI >40
• ASA 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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0 participants in 2 patient groups

Single incision laparoscopic vertical sleeve gastrectomy

Active Comparator group

Description:

Active Comparator Patients in this group will undergo laparoscopic vertical sleeve gastrectomy through a single periumbilical incision.

Treatment:

Procedure: Laparoscopic vertical sleeve gastrectomy

Procedure: Laparoscopic vertical sleeve gastrectomy

Five port laparoscopic vertical sleeve gastrectomy

Active Comparator group

Description:

Patients in this group will undergo conventional laparoscopic vertical sleeve gastrectomy using 5 small incisions.

Treatment:

Procedure: Laparoscopic vertical sleeve gastrectomy

Procedure: Laparoscopic vertical sleeve gastrectomy