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Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding

This study is not yet open for participant recruitment.
Verified February 2013 by Duke University
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01564732
First received: March 7, 2012
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to compare laparoscopic adjustable gastric banding (PLAGB) to standard laparoscopic adjustable gastric banding (SLAGB) in a prospectively randomized clinical trial. We hypothesize the plicated procedure will provide greater short- and long-term excess weight loss than the standard procedure. There exists little prospective randomized data regarding this topic and the recent position statement fro the American Society for Metabolic and Bariatric Surgery (ASMBS) encourages this type of study. Further information on background and design of this study are provided in the detailed description.


Condition Intervention Phase
Morbid Obesity
 Device: Standard-LAGB
Device: Plicated-LAGB
 Phase 4

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: Multicenter Prospective Randomized Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Quantitative Change in Hypertension [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Systolic and Diastolic Blood Pressure will be measured over the scheduled visits and the change in preoperative and postoperative blood pressure will be determined. We will also assess the need for medications to treat hypertension before and after surgery.

  • Quantitative Change in Diabetes [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Blood Sugar will be measured over the scheduled visits and the change in preoperative and postoperative glucose levels will be determined. We will also assess the need for medications to treat diabetes before and after surgery.

  • Quantitative Change in Hyperlipidemia [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Lipid levels will be measured annualy for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hyperlipidemia before and after surgery.

  • Quantitative Change in Hypertriglyceridemia [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Triglyceride levels will be measured annualy for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hypertriglyceridemia before and after surgery.


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard-LAGB
Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.
 Device: Standard-LAGB
The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.
Other Name: Standard Laparoscopic Gastric Banding Surgery
Experimental: Plicated-LAGB
Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.
 Device: Plicated-LAGB
At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.
Other Name: Plicated Laparoscopic Gastric Banding Surgery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age older than 18 years
  • Morbidly obese:
  • BMI > 40, or
  • BMI > 35 + co-morbid obesity related disease condition
  • Without any contraindications to bariatric surgery (eg. Pregnancy, desire to become pregnant in the next 12 months, myocardial infarct within last 6 months, cancer within last 5 years, end stage renal/liver disease, etc.), and
  • Without any metabolic or medically correctable causes for obesity (eg. Untreated hypothyroidism, Prader-Willi, etc.)

Exclusion Criteria:

  • Any patient not meeting the inclusion criteria
  • Patients with any major medical problems contraindicating surgery (eg. Pregnancy, a desire to become pregnant within the next 12 months, myocardial infarct within last 6 months, cancer within last 5 years, end stage renal/liver disease, etc.)
  • Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism, Prader-Willi, etc.)
  • Patients who elect to undergo a surgery other than a LAGB
  • Patient who is unwilling to be randomized to PLAGB or SLAGB
  • Pregnant of planning pregnancy within 12 months
  • Alcohol or drug addiction
  • Established infection anywhere in the body at the time of surgery
  • Previous history of bariatric surgery (except LAGB), intestinal obstruction, or adhesive peritonitis.
  • Family or patient history of autoimmune disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564732

Contacts
Contact: Alfonso Torquati, MD 919-470-7033 alfonso.torquati@dm.duke.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Carol McCloskey, MD         mccloskeyc@upmc.edu    
Sponsors and Collaborators
Duke University
Allergan
Investigators
Principal Investigator: Alfonso Torquati, MD Duke University
Principal Investigator: Carol McCloskey, M.d. University of Pittsburgh
  More Information

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01564732     History of Changes
Other Study ID Numbers: Pro00033638
Study First Received: March 7, 2012
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
morbid obesity
gastric band

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

ClinicalTrials.gov processed this record on May 16, 2013