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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01039077

Enrollment

Registered

2009-12-24

Start date

2009-12-31

Completion date

2012-10-31

Last updated

2015-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Brief 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.

Interventions

PROCEDURELaparoscopic gastric banding

Laparoscopic gastric banding for the treatment of morbid obesity.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* BMI \> 40 * ASA Class I or II

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
weight loss	1 month and 1 year post-operative

Secondary

Measure	Time frame
quality of life	1 week and 3 months post-operative
perioperative complication rate	1 month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026