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

S

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

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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