Pilot Study of Laparoscopic Gastric Plication in Adolescents With Severe Obesity
Condition: Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

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.
    

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
    

Intervention name(s): Laparoscopic Gastric Plication
Intervention type(s): Procedure
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity, pediatric obesity, bariatric, bariatric surgery