Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity
|ClinicalTrials.gov Identifier: NCT01980758|
Recruitment Status : Active, not recruiting
First Posted : November 11, 2013
Last Update Posted : November 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Procedure: Laparoscopic Gastric Plication||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||October 2019|
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.
- Reduction of Excess Body Weight [ Time Frame: 6 months post-surgery ]
- Reduction in comorbidities to obesity [ Time Frame: 6 months ]
- Changes in lifestyle choices [ Time Frame: 1 year ]
- Improvement in quality of life [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980758
|United States, Virginia|
|Children's Hospital of Richmond at VCU|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||David Lanning, MD, PhD||Virginia Commonwealth University|