Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity (NCT01980758) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity
United States4 participantsStarted 2013-05
Plain-language summary
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.
Who can participate
Age range
14 Years – 19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 psycholo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.