Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity|
- Reduction of Excess Body Weight [ Time Frame: 6 months post-surgery ] [ Designated as safety issue: No ]
- Reduction in comorbidities to obesity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Changes in lifestyle choices [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Improvement in quality of life [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||October 2019|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01980758
|Contact: Janet D Delorme, MSfirstname.lastname@example.org|
|United States, Virginia|
|Children's Hospital of Richmond at VCU||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Janet D Delorme, MS 804-527-4756 email@example.com|
|Principal Investigator: David Lanning, MD, PhD|
|Sub-Investigator: Melanie Bean, PhD|
|Sub-Investigator: Edmond Wickham, MD|
|Sub-Investigator: Claudio Oiticica, MD|
|Sub-Investigator: Ronald K Evans, PhD|
|Principal Investigator:||David Lanning, MD, PhD||Virginia Commonwealth University|