NCT01401426

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

July 21, 2011

Last Update Submit

May 18, 2016

Conditions

ObesityNutrition DisordersBody Weight

Keywords

overweightObesity, Morbid

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    1 month and 1 year

Secondary Outcomes (2)

  • Quality of life

    1 week and 3 months

  • Peri-Operative Complications

    1 month

Study Arms (2)

Single incision laparoscopic vertical sleeve gastrectomy

ACTIVE COMPARATOR

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

Procedure: Laparoscopic vertical sleeve gastrectomy

Five port laparoscopic vertical sleeve gastrectomy

ACTIVE COMPARATOR

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

Procedure: Laparoscopic vertical sleeve gastrectomy

Interventions

Laparoscopic vertical sleeve gastrectomyPROCEDURE

Laparoscopic vertical sleeve gastrectomy for the treatment of morbid obesity.

Single incision laparoscopic vertical sleeve gastrectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>40
  • ASA 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, 10019, United States

Location

MeSH Terms

Conditions

ObesityNutrition DisordersBody WeightOverweightObesity, Morbid

Condition Hierarchy (Ancestors)

OvernutritionNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms
0

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

July 21, 2011

First Posted

July 25, 2011

Study Start

July 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

US(1)