Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis

NCT03355326 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: IU-IRB-1611267731
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroschisis

Outcome Measures

Primary Outcomes (1)

• Time to Full Enteral Feeds

  time from study start time to goal full feeds by enteral route (per oral (PO), orogastric (OG), gastrostomy tube (gtube)).

  2 months

Secondary Outcomes (6)

• Time to First Bowel Movement

  1 month

• Hospital Length of Stay

  ~3 months

• Days on Total Parenteral Nutrition (TPN)

  2 months

• Number of Participants With Sequela of Long Term Total Parenteral Nutrition (TPN) Administration

  ~3 months

• Number of Participants With Infectious Complications

  ~3 months

Study Arms (2)

Glycerin Suppository Group

EXPERIMENTAL

Drug: Glycerin Suppository

Non-suppository Group

NO INTERVENTION

Interventions

Glycerin Suppository DRUG

Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.

Glycerin Suppository Group

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Gastroschisis

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Alan Ladd, Principle Investigator
• Organization: Indiana University, School of Medicine

aladd@iupui.edu

317-274-4606

Study Officials

• Alan Ladd, M.D.

  Program Director, Department of General Surgery, Divison of Pediatric Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 28, 2017
• Study Start: October 1, 2017
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)