We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01401426
Recruitment Status : Withdrawn
First Posted : July 25, 2011
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

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.

Condition or disease Intervention/treatment
Obesity Nutrition Disorders Body Weight Procedure: Laparoscopic vertical sleeve gastrectomy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery
Study Start Date : July 2010
Primary Completion Date : September 2010
Study Completion Date : September 2010

Arm Intervention/treatment
Active Comparator: Single incision laparoscopic vertical sleeve gastrectomy
Active Comparator Patients in this group will undergo laparoscopic vertical sleeve gastrectomy through a single periumbilical incision.
Procedure: Laparoscopic vertical sleeve gastrectomy
Laparoscopic vertical sleeve gastrectomy for the treatment of morbid obesity.
Active Comparator: Five port laparoscopic vertical sleeve gastrectomy
Patients in this group will undergo conventional laparoscopic vertical sleeve gastrectomy using 5 small incisions.
Procedure: Laparoscopic vertical sleeve gastrectomy
Laparoscopic vertical sleeve gastrectomy



Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 1 month and 1 year ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 1 week and 3 months ]
  2. Peri-Operative Complications [ Time Frame: 1 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI >40
  • ASA I or II

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401426


Locations
United States, New York
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01401426     History of Changes
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016

Keywords provided by St. Luke's-Roosevelt Hospital Center:
overweight
Obesity, Morbid

Additional relevant MeSH terms:
Body Weight
Nutrition Disorders
Signs and Symptoms