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Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis

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ClinicalTrials.gov Identifier: NCT03355326
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Collaborators:
Alan Ladd, M.D.
Robert Vandewalle, M.D.
Teresa VanHorn
Information provided by (Responsible Party):
Indiana University

Brief 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.


Condition or disease Intervention/treatment Phase
Gastroschisis Drug: Glycerin Suppository Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Routine Administration of Glycerin Suppositories to Improve Bowel Function in Patients With Uncomplicated Gastroschisis
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
Drug Information available for: Glycerin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Glycerin Suppository Group Drug: Glycerin Suppository
Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
No Intervention: Non-suppository Group



Primary Outcome Measures :
  1. Time to full enteral feeds [ Time Frame: 2 months ]


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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

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 ClinicalTrials.gov identifier (NCT number): NCT03355326


Contacts
Contact: Teresa N VanHorn (317) 274-4611 tnvanhor@iu.edu
Contact: Robert Vandewalle, M.D. (317) 274-4604 rvandewa@iupui.edu

Locations
United States, Indiana
Riley Hospital for Children Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Teresa VanHorn    317-274-4611    tnvanhor@iu.edu   
Sponsors and Collaborators
Indiana University
Alan Ladd, M.D.
Robert Vandewalle, M.D.
Teresa VanHorn
Investigators
Principal Investigator: Alan Ladd, M.D. Program Director, Department of General Surgery, Divison of Pediatric Surgery

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT03355326     History of Changes
Other Study ID Numbers: IU-IRB-1611267731
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Hernia, Abdominal
Hernia
Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs