Plicated Laparoscopic Adjustable Gastric Banding Study

Weight Loss Clinical Trial

Official title:

Prospective Clinical Trial of Plicated Laparoscopic Adjustable Gastric Banding

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01944111
• Other study ID #: 2315-1
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: September 12, 2013
• Last updated: September 16, 2013
• Start date: September 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2013
• Source: Tenet Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Compare plicated laparoscopic adjustable gastric banding to standard laparoscopic adjustable gastric banding in prospective clinical trial.

Description:

This is a prospective clinical trial comparing experimental plicated adjustable gastric banding versus standard adjustable gastric banding. All enrolled patients will choose to either standard (control group) banding or plication (study group) banding. Each patient will complete a standardized survey rating their satisfaction from surgery, their satiety levels and Green Zone Patient Questionnaire at each visit.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age older than 18 years

• Morbidly Obese

• BMI >40 or

• BMI >35 plus co-morbid obesity related disease conditions

• Without contraindications to bariatric surgery: eg pregnancy, desire to become pregnant within the next 12 months, myocardial infarct within the last 6 months, cancer within last 5 years, end stage renal/liver disease

• Without any metabolic or medically correctable causes for obesity: eg untreated hypothyroidism, Prader-Willi

Exclusion Criteria:

• Any patient not meeting the inclusion criteria

• Patients with any major medical problems contraindicating surgery

• Patients with a medically treatable cause of obesity

• Patients who elect to undergo a surgery other than Plication adjustable gastric banding or standard adjustable gastric banding

• Alcohol or drug addiction

• Established infection anywhere in the body at the time of surgery

• Previous history of bariatric surgery, intestinal obstruction, or adhesive peritonitis

• Family or patient history of autoimmune disease

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Weight Loss

Intervention

Device:
• Plication
Prospective clincial trial comparing adjustable gastric banding with plication versus standard adjustable gastric banding. Variables to be studied include patient age, gender, ethnicity, co-morbid disease conditions, height, weight, BMI, intra-operative data such as operative time and blood loss and post-operative outcomes including length of hosptial stay, complication rates, weight loss, and co-morbid disease resolution.

Locations

Country	Name	City	State
United States	Des Peres Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Tenet Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Weight loss 4 weeks post surgical:20% additional than without plication, 3months post surgical: 30% additional than without plication, 6 months post surgical:30-40% additional than without plication, 1 year post surgical = 30-40% additional than without plication & at 1 year patient will require 50% fewer adjustments than without plication.	at least 1 year	No