Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|