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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01401426

Enrollment

Registered

2011-07-25

Start date

2010-07-31

Completion date

2010-09-30

Last updated

2016-05-19

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

Conditions

Body Weight, Nutrition Disorders, Obesity

Keywords

overweight, Obesity, Morbid

Brief summary

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.

Interventions

PROCEDURELaparoscopic vertical sleeve gastrectomy

Laparoscopic vertical sleeve gastrectomy 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 70 Years

Healthy volunteers

Inclusion criteria

* BMI \>40 * ASA 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

Secondary

Measure	Time frame
Quality of life	1 week and 3 months
Peri-Operative Complications	1 month

Countries

United States

Outcome results

None listed

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