Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis
Condition: Gastroschisis
MeSH terms: Gastroschisis
Intervention: Glycerin Suppository
Intervention description: Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
Intervention MeSH terms: Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 1 Day
Maximum age: 1 Year
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Gastroschisis is a congenital defect of the abdominal wall that leads to evisceration of
      various amounts of the abdominal organs. The mainstay of therapy is restoring continuity of
      the abdominal wall, either through primary closure or with a synthetic graft when primary
      closure is not feasible.

      It has been established that bowel function after repair of gastroschisis is impaired due to
      the aforementioned pathological processes. Previous studies have shown that the time from
      surgery to attaining full nutrition through enteral means is a predictor for morbidity in
      this population. Therefore, numerous therapeutic interventions have been proposed to help
      hasten bowel function and decrease the time to tolerance of total enteral nutrition. A
      common, but unproven, technique is the use of glycerin suppositories to stimulate bowel
      function. The concept of glycerin suppositories is that stimulating colonic activity through
      the use of the suppository will stimulate small intestinal function. The underlying concept
      is that improved bowel motility and reduced time to full enteral feeds will reduce the
      morbidity associated with this disease. While the formation/evacuation of stools is most
      easily monitored, the main purpose of using these suppositories is to hasten tolerance of
      nutrition through enteral means.

      While the practice of using glycerin suppositories is common in neonates, there is no
      literature or best-practice guidelines advocating for (or against) their use. A single
      previous prospective study utilizing glycerin suppositories in premature, low birth weight
      neonates failed to show any benefit in improving time to tolerate full enteral feeds. At this
      time, this is the only study investigating the use of glycerin suppositories in any neonatal
      population, and due to the indications (i.e. premature and low birth weight infants without
      surgical disease), the findings are not applicable to neonates with gastroschisis. To the
      authors' knowledge, there are no previous studies or current ongoing studies examining this
      question. Given this lack of information regarding the efficacy of glycerin suppositories,
      there is a significant variation in practice among practicing surgeons, including timing of
      initial administration, frequency of use, and indication to discontinue. Indeed the spectrum
      ranges from some surgeons who never use glycerin suppositories, to some who prescribe them
      daily for all gastroschisis patients immediately following surgery.

      The purpose of this study will be to determine whether routine use of glycerin suppositories
      improves bowel function as measured by time to full enteral feeds (primary outcome: defined
      as enteral feed volume >120mL/kg/day with appropriate weight gain (20-30g/day for two
      consecutive days)) in neonates with uncomplicated gastroschisis after complete reduction of
      abdominal viscera. Secondary outcomes include time to first bowel movement and
      incidence/severity of TPN-induced cholestasis in the study groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of uncomplicated gastroschisis

          -  Gestational age >33 weeks at time of delivery

          -  Weight >1900g at time of delivery

          -  Transfer of patient to Riley Hospital for Children prior to any abdominal surgery

        Exclusion Criteria:

          -  Neurological Congenital malformations and/or those known to impair intestinal motility

          -  Additional congenital gastrointestinal abnormalities requiring surgical intervention

          -  Congenital Cyanotic heart disease

          -  Surgical Closure of abdominal wall defect with prosthetic material (e.g. prosthetic or
             bio-prosthetic mesh)