Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity
The proposed study aims to investigate the effects of laparoscopic gastric plication (LGP) on excess body weight, body mass index, and weight-related medical and psychological co-morbidities in obese adolescents. Additionally, we will evaluate the safety and efficacy of this procedure (implemented within a multidisciplinary comprehensive lifestyle modification program) on changes in the patients' medical status, psychosocial and psychological functioning, physical fitness, and health-related quality of life.
- Laparoscopic gastric plication performed on carefully selected obese adolescents within a multidisciplinary treatment program providing pre and post-surgical behavioral and psychological support and education will result in: a) initial and sustained reductions in excess body weight and body mass index, b) improvements in psychological functioning, physical fitness, and health-related quality of life, and c) reduction in weight-related comorbidities.
- LGP will be a safe procedure, with complication rates that are comparable to or lower than what has been found in other published reports of surgical weight loss procedures used in obese adolescents.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity|
- Reduction of Excess Body Weight [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
- Reduction in comorbidities to obesity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Changes in lifestyle choices [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Improvement in quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||October 2019|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Laparoscopic Gastric Plication
Procedure: Laparoscopic Gastric Plication
The study will examine the effects of a type of weight loss surgery on obese adolescents age 14-19. ) The study protocol includes pre-treatment assessments followed by a 2-month education and lifestyle modification treatment program. Following surgery, comprehensive follow-up care will be provided over a 3 year period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01980758
|Contact: Janet D Delorme, MSfirstname.lastname@example.org|
|United States, Virginia|
|Children's Hospital of Richmond at VCU||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Janet D Delorme, MS 804-527-4756 email@example.com|
|Principal Investigator: David Lanning, MD, PhD|
|Sub-Investigator: Melanie Bean, PhD|
|Sub-Investigator: Edmond Wickham, MD|
|Sub-Investigator: Claudio Oiticica, MD|
|Sub-Investigator: Ronald K Evans, PhD|
|Principal Investigator:||David Lanning, MD, PhD||Virginia Commonwealth University|