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Gastrografin for Treating Small Bowel Obstruction in Children

NCT03573921 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-11-01

No results posted yet for this study

Summary

This is a multi-centre clustered open label clinical trial testing the effectiveness of adding Gastrografin to standard non-surgical management of small bowel obstruction. Gastrografin is a radiopaque contract agent that exhibits a mild laxative effective due to its high osmolarity and ability to pull water into the intestines and bowels as a lubricant. Small bowel obstruction is a mechanical or function obstruction that prevents normal bowel function. The standard treatment for small bowel obstruction is non-surgical and includes decompressing the abdomen, fluid resuscitation, nothing by mouth, and time. In some cases if non-surgical management is not effective in resolving the obstruction, surgical intervention is required. Gastrografin in addition to standard non-surgical management has been shown to reduce the rate of surgery, length of hospital stay, and time to resolution in similar clinical scenarios, such as meconium ileus and meconium plug syndrome. However, it has never been tested in children with small bowel obstruction. This study is a clustered open label study, meaning that each participating centre will select the type of treatment they will offer at their centre. The treatment options are either the Gastrografin arm (a single dose of Gastrografin plus non-surgical management) or the Control arm (a single dose of saline solution plus non-surgical management). After each group receives saline or Gastrografin they will continue with the same non-surgical treatment that patients not participating in the trial would receive. Participating in the study does not preclude the need for urgent or emergent surgical intervention and at any point in the study, if the patient requires surgery for their small bowel obstruction they will undergo surgical intervention. The outcomes of this study are the rate of surgical intervention, length of stay, time to first and full feeds, and rate of complications.

Conditions

  • Small Bowel Obstruction

Interventions

DRUG

Gastrografin

Patients will receive a single dose of Gastrografin via the nasogastric tube at 24 hours after hospital admission. After receiving Gastrografin, patients will receive the same standard non-surgical management that patients outside of the trial receive.

OTHER

Saline solution (control treatment)

Patients will receive a single dose of saline solution via the nasogastric tube at 24 hours after hospital admission. After receiving saline solution, patients will receive the same standard non-surgical management that patients outside of the trial receive.

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-12-19
Completion
2022-12-19

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03573921 on ClinicalTrials.gov