Topical Minoxidil Versus Topical Glyceryl Trinitrate in Treatment of Chronic Anal Fissure
Topical 5% Minoxidil Versus 0.2%Topical Glyceryl Trinitrate in Treatment of Chronic Anal Fissure: a Randomized Controlled Trial
1 other identifier
interventional
62
1 country
1
Brief Summary
This randomized trial aims to compare two topical treatments in the treatment of chronic anal fissure: minoxidil gel and glycreyl trintrate cream. The endpoint of the study is the duration of healing of anal fissure whereas secondary endpoints include adverse effects of each treatment and recurrence of anal fissure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2018
CompletedStudy Start
First participant enrolled
May 10, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedOctober 7, 2019
October 1, 2019
1.3 years
May 6, 2018
October 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Healing duration
the duration of time needed for complete healing defined as reepithelialization of the anoderm at the site of anal fissure
two months
Secondary Outcomes (1)
Anal pain
three months
Study Arms (2)
Minoxidil
ACTIVE COMPARATORPatients in this arm will receive topical treatment with Minoxidil forte 5% gel three times per days for 4 weeks
Glyceryl trinitrate
ACTIVE COMPARATORPatients in this arm will receive topical treatment with glyceryl trinitrate 0.2% cream three times per days for 4 weeks
Interventions
application of minoxidil forte 5% gel three time per day on the anus for four weeks
application of glyceryl trinitrate 0.2% cream three time per day on the anus for four weeks
Eligibility Criteria
You may qualify if:
- Patients of both genders presenting with chronic anal fissure of more than 6 weeks in duration
- Ageing between 18 and 65 years old.
You may not qualify if:
- Pregnant patients.
- Patients with recurrent anal fissure after previous sphincterotomy.
- Patients with coexisting anorectal diseases or inflammatory bowel diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Related Publications (1)
Emile SH, Abdel-Razik MA, Elshobaky A, Elbaz SA, Khafagy W, Shalaby M. Topical 5% minoxidil versus topical 0.2% glyceryl trinitrate in treatment of chronic anal fissure: A randomized clinical trial. Int J Surg. 2020 Mar;75:152-158. doi: 10.1016/j.ijsu.2020.01.143. Epub 2020 Feb 4.
PMID: 32028023DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sameh Emile, M.D.
Mansoura University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of general surgery
Study Record Dates
First Submitted
May 6, 2018
First Posted
May 18, 2018
Study Start
May 10, 2018
Primary Completion
August 30, 2019
Study Completion
September 30, 2019
Last Updated
October 7, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share