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Laparoscopic Sleeve Gastrectomy Plus Weight Watchers vs. Weight Watchers Alone in Underserved Minority Women

NCT01929850 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-05-08

No results posted yet for this study

Summary

Obesity is a costly multi-etiology world disease of fat storage. Morbid obesity is defines as greater than 100 pounds overweight and/or greater than 200 % of ideal body weight. Chronic underemployment, poor housing, child abuse, limited education, stress and anxiety are all associated with maternal morbid obesity. These latter conditions leave many patients in a state of economic, social and emotional poverty with need for life-long welfare support. For patients with true morbid obesity a standard surgical procedure is currently the procedure of choice especially among patients who fail standard medical intervention. The major procedures performed for morbid obesity include the Roux-en-Y gastric bypass, sleeve gastrectomy and laparoscopic band procedure. The sleeve gastrectomy is purely a restrictive procedure without malabsorptive components which involves one single staple line and can be performed laparoscopically in less than one hour. While these surgical procedures are recognized as "standard" procedures for patient who have failed medical treatment and are "covered" by most health plans, access to these procedures is limited for the medically underserved, rural, poor or underrepresented minorities since national, state and municipal health plans either provide minimal coverage or no coverage at all for surgery for morbid obesity. Reimbursement to providers offering these procedures is minimal and thus access to bariatric surgery is unlikely within a timely fashion.

Conditions

  • Morbid Obesity

Interventions

PROCEDURE

Laparscopic Sleeve Gastrectomy

The laparoscopic sleeve gastrectomy involves the placement of 5 trocars. A leak check may be performed at the same time by insufflating with a gastroscope with the remnant gastric section submerged in irrigation fluid and by infusing sterile methylene blue through a nasogastric tube. The staple line may be oversewn (3-0 Vicryl, Ethicon), only along the bleeding and leakage areas, or areas with the potential for such complications. A nasogastric decompression tube placed to monitor bleeding and an intraperitoneal drain was placed under an anastomotic stoma.

BEHAVIORAL

Weight Watchers Program

Intensive medically supervised nutritional and exercise therapy

Sponsors & Collaborators

Principal Investigators

  • John P Cello, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Primary Completion
2018-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01929850 on ClinicalTrials.gov