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The Use of Gastrografin to Help Alleviate Bowel Obstruction in Gastroschisis Patients.

NCT03334578 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-11-01

No results posted yet for this study

Summary

This study will investigate the use of a drug called Gastrografin to aid in bowel mobility for paediatric patients who have undergone gastroschisis surgery. Gastroschisis is an abdominal wall birth defect where the bowel protrudes through a small opening beside the umbilicus. In these patients, the bowel is often less mobile due to its exposure outside of the body during fetal development. It is common for the bowel to be swollen and matted, which decreases motility and makes it increasingly difficult for the baby to have normal bowel function. Administering Gastrografin facilitates the entry of water into the intestines and bowel, which is thought to aid in bowel function and motility. This study will compare gastroschisis patients who received Gastrografin to gastroschisis patients collected as part of an ongoing observational study at our centre who did not receive Gastrografin.

Conditions

  • Gastroschisis
  • Bowel Obstruction
  • Birth Defect

Interventions

DRUG

Gastrografin

Gastrografin group

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
32 Weeks
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-03
Primary Completion
2020-12-17
Completion
2020-12-17

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 NCT03334578 on ClinicalTrials.gov