Study Summary
This trial looks at whether a non-surgical bundle can help prevent or treat gastrocutaneous fistulas, which are a common complication of gastrostomy tubes.
Eligible Conditions
- Gastrocutaneous Fistula
- Gastrostomy Complications
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 1 month
1 month
Caregiver satisfaction Survey
Gastrocutaneous Fistula (GCF)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
1 Treatment Group
Intervention
1 of 1
Experimental Treatment
100 Total Participants · 1 Treatment Group
Primary Treatment: oral anti-acid treatment · No Placebo Group · Phase 4
Intervention
Drug
Experimental Group · 1 Intervention: oral anti-acid treatment · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,328 Previous Clinical Trials
1,534,587 Total Patients Enrolled
St. Justine's HospitalOTHER
179 Previous Clinical Trials
76,985 Total Patients Enrolled
Montreal Children's Hospital of the MUHCOTHER
25 Previous Clinical Trials
8,754 Total Patients Enrolled
Eligibility Criteria
Age < 65 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- St-Louis, Etienne, Nadia Safa, Elena Guadagno, and Robert Baird. 2018. “Gastrocutaneous Fistulae in Children — A Systematic Review and Meta-analysis of Epidemiology and Treatment Options”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2018.02.022.
- St-Louis E, Safa N, Guadagno E, Baird R. Gastrocutaneous fistulae in children - A systematic review and meta-analysis of epidemiology and treatment options. J Pediatr Surg. 2018 May;53(5):946-958. doi: 10.1016/j.jpedsurg.2018.02.022. Epub 2018 Feb 8.
- Robert Baird 2019. "A Prospective Evaluation of Non-Operative Treatments for Gastrocutaneous Fistulae in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03920306.
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Conditions
Cancer Related
Treatments