Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity

NCT01980758 | Completed DMC

• 1 other identifier: HM14809
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Obesity

Keywords

obesity, pediatric obesity, bariatric, bariatric surgery

Outcome Measures

Primary Outcomes (1)

• Reduction of Excess Body Weight

  6 months post-surgery

Secondary Outcomes (3)

• Reduction in comorbidities to obesity

  6 months

• Changes in lifestyle choices

  1 year

• Improvement in quality of life

  3 years

Study Arms (1)

Surgery

EXPERIMENTAL

Laparoscopic Gastric Plication

Procedure: Laparoscopic Gastric Plication

Interventions

Laparoscopic Gastric Plication PROCEDURE

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.

Surgery

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Children's Hospital of Richmond: collaborator

Study Sites (1)

Children's Hospital of Richmond at VCU

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Lanning, MD, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: November 11, 2013
• Study Start: May 1, 2013
• Primary Completion: March 8, 2018
• Study Completion: March 8, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

US (1)