Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01980758
Recruitment Status : Active, not recruiting
First Posted : November 11, 2013
Last Update Posted : November 6, 2017
Children's Hospital of Richmond
Information provided by (Responsible Party):
Virginia Commonwealth University

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. 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.

Condition or disease Intervention/treatment Phase
Obesity Procedure: Laparoscopic Gastric Plication Not Applicable

Detailed Description:
The complete study protocol, which is described in detail below, spans 3 years and includes 11 research assessment points (Pre-1, Pre-2, T0, T1, T2, T3, T4, T5, T6, T7, and T8). Please refer to Figure 2. Study Protocol from Enrollment to Post-Surgical Assessments. Select pre-treatment assessments will be conducted initially (Pre-1), followed by a 2-month pre-surgical education and lifestyle modification treatment program, consisting of four visits with psychology, nutrition, exercise, and surgery. After successful completion of this pre-surgical education program, a more comprehensive pre-surgical assessment by a surgeon (Pre-2) will be conducted. If patients decide to pursue the study, in the two weeks prior to surgery, participants will be asked to adhere to a pre-surgical diet, exclusion and inclusion criteria will be reviewed again by the study team, and verbal consent/assent will be re-confirmed with adolescents and parent(s). Following surgery (T0), comprehensive follow-up care will be provided via the multidisciplinary team at the Healthy Lifestyles Center (HLC) at Children's Hospital of Richmond at Virginia Commonwealth University (CHoR at VCU). The follow-up period will be divided into three phases: 1) Early Post-Operative Phase (0-5 months), 2) Late Post-Operative phase (6-12 months), and 3) Long-term Follow-up Phase (13-36 months). In conjunction with clinical follow-up, repeat standardized research assessments will be conducted post-operatively at 1-2 weeks (T1), 6 weeks (T2), 3 months (T3), 6 months (T4), 12 months (T5), 18 months (T6), 24 months (T7), and 36 months (T8). Specific screening, pre-surgical, perioperative, and post-surgical study procedures at each time point are described fully below and outlined in Figure 2 and Table 1. Additionally, all research measures are described in detail in the Measures Section. If any participant requires any additional visit during the time of this study, data from these visits will also be collected for this study. Care directly related to the surgery and study will not be billed but other medical issues such as hypertension, diabetes, hypercholesterolemia and depression may require management outside of the scope of the study and will be billed accordingly

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Surgery
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.

Primary Outcome Measures :
  1. Reduction of Excess Body Weight [ Time Frame: 6 months post-surgery ]

Secondary Outcome Measures :
  1. Reduction in comorbidities to obesity [ Time Frame: 6 months ]
  2. Changes in lifestyle choices [ Time Frame: 1 year ]
  3. Improvement in quality of life [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01980758

United States, Virginia
Children's Hospital of Richmond at VCU
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Children's Hospital of Richmond
Principal Investigator: David Lanning, MD, PhD Virginia Commonwealth University

Responsible Party: Virginia Commonwealth University Identifier: NCT01980758     History of Changes
Other Study ID Numbers: HM14809
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Virginia Commonwealth University:
obesity, pediatric obesity, bariatric, bariatric surgery

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms