Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity

Completed · Not applicable

Conditions studied: Obesity

In brief

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. Study hypothesis: 1. 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. 2. 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.

Key facts

Study ID

NCT01980758

Run by

Virginia Commonwealth University

People needed

4

Starts

2013-05-01

Expected to finish

2018-03-08

Last updated by the study team

2018-07-10

Who can join

Age: 14 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 14 - 19.
• At physical maturity.
• BMI of greater than or equal to 35 kg/m2 with major comorbidities, or BMI of greater than 40 kg/m2 with other weight related comorbidities.
• Must have undergone comprehensive pre-surgical assessments by a multi-disciplinary team.
• Must have at least 6 months of medically observed and attempted non-surgical weight loss.
• Must have demonstrated suboptimal weight loss following participation in a lifestyle intervention.
• Must have parents involved in all phases of recruitment and intervention.

You may not qualify if…

• Underlying genetic or endocrine disorder, which would preclude weight loss through behavioral and surgical techniques.
• Less than six months of participation in a medically-supervised weight management efforts.
• Active untreated, unstable psychopathology (to include active psychosis, severe depression, or significant eating pathology), as determined by psychological evaluation.
• Active suicidal ideation, as determined by psychological evaluation.
• Inadequate social support, as determined by psychological evaluation.
• Inability to provide informed consent/assent, as evidenced by clinical interview and cognitive assessments.
• Severe mental retardation, as evidenced by clinical interview and cognitive assessments.
• Demonstrated pattern of poor adherence to medical regimen and lifestyle modification.
• Active substance abuse, including tobacco use, as demonstrated by clinical interview and psychological evaluation. Inadequate knowledge of risks and patient responsibilities, as determined by clinical interview and knowledge quiz.
• Reported pregnancy within the past year, current pregnancy, or planning to become pregnant in the next three years.
• History or clinical symptoms of severe gastrointestinal reflux disease (GERD)
• Person is not deemed for medical reasons to be a surgical candidate.

Where it is running

• Children's Hospital of Richmond at VCU — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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