The effect of Mitomycin C in children with long caustic esophageal strictures

Phase 2

Completed

• Conditions: dysphagia in children with caustic esophageal stricture; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12613001070729
• Lead Sponsor: Pediatric Surgery Department, Ain Shams University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

patients with long segment (> 3 cm) caustic esophageal stricture

Exclusion Criteria

short strictures (< 3 cm in length)
patients underwent previous esophageal surgery
undilatable strictures
patients known to have a hypersensitivity or contraindication for mitomycin c

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
percentage of patients that get resolved from dysphagia<br>(no. of patients that got resolved from dysphagia/total no of the patients x 100)<br><br>dysphagia is assessed according to dysphagia scoring system graded from 0 to 4 (where 0 represent no dysphagia, 1 = dysphagia to solids, 2 = dysphagia to semisolids, 3 = dysphagia to fluids, 4 = absolute dysphagia even to saliva)[1 year after last dilatation session]

Secondary Outcome Measures

Name	Time	Method
number of dilatation sessions needed to get free from dysphagia[1 year after last dilatation session]