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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by St. Luke's-Roosevelt Hospital Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01401426
First received: July 21, 2011
Last updated: July 16, 2014
Last verified: July 2010
  Purpose

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 Intervention
Obesity
Nutrition Disorders
Body Weight
Procedure: Laparoscopic vertical sleeve gastrectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Prospective Trial: Single Port Laparoscopic Vertical Sleeve Gastrectomy Versus Conventional Five Port Laparoscopic Vertical Sleeve Gastrectomy Surgery

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 1 month and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 week and 3 months ] [ Designated as safety issue: No ]
  • Peri-Operative Complications [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401426

Contacts
Contact: Julio A Teixeira, MD 212-636-1000

Locations
United States, New York
St. Luke's Roosevelt Hospital Center Not yet recruiting
New York, New York, United States, 10019
Contact: Julio Teixeira    212-636-1000      
Principal Investigator: Julio A Teixeira, MD         
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01401426     History of Changes
Other Study ID Numbers: NCT01039130
Study First Received: July 21, 2011
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Body Weight
Malnutrition
Nutrition Disorders
Obesity
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014