NCT01039077

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

August 6, 2015

Status Verified

August 1, 2015

Enrollment Period

2.8 years

First QC Date

December 22, 2009

Last Update Submit

August 5, 2015

Conditions

Morbid Obesity

Outcome Measures

Primary Outcomes (1)

  • weight loss

    1 month and 1 year post-operative

Secondary Outcomes (2)

  • quality of life

    1 week and 3 months post-operative

  • perioperative complication rate

    1 month

Study Arms (2)

Single incision laparoscopic gastric banding

ACTIVE COMPARATOR

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

Procedure: Laparoscopic gastric banding

Five port laparoscopic gastric banding

ACTIVE COMPARATOR

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

Procedure: Laparoscopic gastric banding

Interventions

Laparoscopic gastric bandingPROCEDURE

Laparoscopic gastric banding for the treatment of morbid obesity.

Five port laparoscopic gastric bandingSingle incision laparoscopic gastric banding

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 40
  • ASA Class I or II

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's-Roosevelt Hospital Center

New York, New York, 10025, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Julio Teixeira, MD

    St. Luke's-Roosevelt Hospital Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

December 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

August 6, 2015

Record last verified: 2015-08

Locations

US(1)