Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001070729
Ethics application status
Approved
Date submitted
21/09/2013
Date registered
25/09/2013
Date last updated
25/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Mitomycin C in children with long caustic esophageal strictures
Scientific title
The effect of topical Mitomycin C application on resolution of dysphagia in children with long segment caustic esophageal strictures
Secondary ID [1] 283281 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dysphagia in children with caustic esophageal stricture 290157 0
Condition category
Condition code
Oral and Gastrointestinal 290549 290549 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
topical mitomycin c is applied on the site of esophageal stricture after endoscopic dilatation.
mitomycin c is prepared to have a concentration of 0.5 mg/ml to be applied on the stricture site for 5 minutes. this application is done once for 5 min at the session of endoscopic dilatation session.
endoscopic dilatation is done using flexible endoscopy and wire guided malleable dilator, we perform a dilatation session every 2 weeks in first 3 months then monthly for the next 9 months.
endoscopic dilatation is done regularly at this scheduled sessions, and mitomycin application is done every other session . this applied for 2 to 6 times according to the response of each patient and the improvement of his dysphagia ( if he get free after 2 application, no more sessions is needed)(and if he didn't get improved , we continue to 6 application times).
Intervention code [1] 288004 0
Treatment: Drugs
Intervention code [2] 288020 0
Treatment: Other
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290571 0
percentage of patients that get resolved from dysphagia
(no. of patients that got resolved from dysphagia/total no of the patients x 100)

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)
Timepoint [1] 290571 0
1 year after last dilatation session
Secondary outcome [1] 304810 0
number of dilatation sessions needed to get free from dysphagia
Timepoint [1] 304810 0
1 year after last dilatation session

Eligibility
Key inclusion criteria
patients with long segment (> 3 cm) caustic esophageal stricture
Minimum age
1 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2009
Actual
16/01/2009
Date of last participant enrolment
Anticipated
Actual
10/06/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5436 0
Egypt
State/province [1] 5436 0

Funding & Sponsors
Funding source category [1] 288015 0
University
Name [1] 288015 0
Pediatric Surgery Department, Ain Shams University
Country [1] 288015 0
Egypt
Primary sponsor type
University
Name
Pediatric Surgery Department, Ain Shams University
Address
56 Ramsis st., El-Abbasia
postal code: 11566
Country
Egypt
Secondary sponsor category [1] 286736 0
Hospital
Name [1] 286736 0
El-Demerdash hospital
Address [1] 286736 0
56 Ramsis st., El-Abbasia
postal code: 11566
Country [1] 286736 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289943 0
pediatric surgery departmnet, Ain Shams University
Ethics committee address [1] 289943 0
Ethics committee country [1] 289943 0
Egypt
Date submitted for ethics approval [1] 289943 0
Approval date [1] 289943 0
01/01/2009
Ethics approval number [1] 289943 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43198 0
Dr Khaled Mohamed El-Asmar
Address 43198 0
14 mostafa Sdek El-Rafeay, Heliopolis
postal code: 11361
Ain Shams University hospitals
Country 43198 0
Egypt
Phone 43198 0
+2 01001222624
Fax 43198 0
Email 43198 0
[email protected]
Contact person for public queries
Name 43199 0
Khaled Mohamed El-Asmar
Address 43199 0
14 mostafa Sdek El-Rafeay, Heliopolis
postal code: 11361
Ain Shams University hospitals
Country 43199 0
Egypt
Phone 43199 0
+2 01001222624
Fax 43199 0
Email 43199 0
[email protected]
Contact person for scientific queries
Name 43200 0
Khaled Mohamed El-Asmar
Address 43200 0
14 mostafa Sdek El-Rafeay, Heliopolis
postal code: 11361
Ain Shams University hospitals
Country 43200 0
Egypt
Phone 43200 0
+2 01001222624
Fax 43200 0
Email 43200 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.