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

Primary Purpose

Obesity, Nutrition Disorders, Body Weight

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic vertical sleeve gastrectomy
Laparoscopic vertical sleeve gastrectomy
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring overweight, Obesity, Morbid

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BMI >40
  • ASA I or II

Exclusion Criteria:

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

Sites / Locations

  • St. Luke's Roosevelt Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single incision laparoscopic vertical sleeve gastrectomy

Five port laparoscopic vertical sleeve gastrectomy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Weight Loss

Secondary Outcome Measures

Quality of life
Peri-Operative Complications

Full Information

First Posted
July 21, 2011
Last Updated
May 18, 2016
Sponsor
St. Luke's-Roosevelt Hospital Center
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1. Study Identification

Unique Protocol Identification Number
NCT01401426
Brief Title
Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery
Official Title
Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Nutrition Disorders, Body Weight
Keywords
overweight, Obesity, Morbid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single incision laparoscopic vertical sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
Active Comparator Patients in this group will undergo laparoscopic vertical sleeve gastrectomy through a single periumbilical incision.
Arm Title
Five port laparoscopic vertical sleeve gastrectomy
Arm Type
Active Comparator
Arm Description
Patients in this group will undergo conventional laparoscopic vertical sleeve gastrectomy using 5 small incisions.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic vertical sleeve gastrectomy
Intervention Description
Laparoscopic vertical sleeve gastrectomy for the treatment of morbid obesity.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic vertical sleeve gastrectomy
Intervention Description
Laparoscopic vertical sleeve gastrectomy
Primary Outcome Measure Information:
Title
Weight Loss
Time Frame
1 month and 1 year
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
1 week and 3 months
Title
Peri-Operative Complications
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI >40 ASA I or II Exclusion Criteria: Comorbid cardiac, pulmonary, renal, hepatic disease Bleeding disorder Previous gastric/esophageal surgery
Facility Information:
Facility Name
St. Luke's Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

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

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