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Topical Minoxidil Versus Topical Glyceryl Trinitrate in Treatment of Chronic Anal Fissure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03528772
Recruitment Status : Completed
First Posted : May 18, 2018
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, Mansoura University

Tracking Information
First Submitted Date  ICMJE May 6, 2018
First Posted Date  ICMJE May 18, 2018
Last Update Posted Date October 7, 2019
Actual Study Start Date  ICMJE May 10, 2018
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2019)
Healing duration [ Time Frame: two months ]
the duration of time needed for complete healing defined as reepithelialization of the anoderm at the site of anal fissure
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2018)
Healing duration [ Time Frame: three months ]
the duration of time needed for complete healing defined as reepithelialization of the anoderm at the site of anal fissure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2018)
Anal pain [ Time Frame: three months ]
degree of relief of anal pain as measured by visual analogue scale (VAS) from 0 to 10 where 0 indicates no pain and 10 indicates the worst severe pain.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2018)
Anal pain [ Time Frame: three months ]
degree of relief of anal pain as measured by visual analogue scale from 0 to 10
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Minoxidil Versus Topical Glyceryl Trinitrate in Treatment of Chronic Anal Fissure
Official Title  ICMJE Topical 5% Minoxidil Versus 0.2%Topical Glyceryl Trinitrate in Treatment of Chronic Anal Fissure: a Randomized Controlled Trial
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
Detailed Description

All participants who fulfill the inclusion criteria and give consent for participation in the trial and will be included and randomly assigned to either group I (5% Minoxidil gel) or group II (0.2% GTN cream) with a 1:1 allocation. Randomization will be carried out using online software (Research Randomizer Version 4.0 at https://www.randomizer.org).

Patients will receive the topical agent in unlabeled red or blue containers. The code of each color will be known to a pharmacist who will not take any part in patients' care, follow-up, data collection/analysis or accessing outcomes of the study. The investigators will be blinded to the nature of content of each container and the outcome assessor will not be aware of the study nature.

Interventions Eligible patients will be randomized into two equal groups: groups I will receive topical 5% Minoxidil gel (Minoxidil Forte 5% topical gel 60 gm; Pharmacare Egypt Co., Cairo, Egypt) and group II will receive topical 0.2% GTN cream (Nitoglycerine-Glycerile Tinitrade 0.2%, 30 gm; E.S.A.G Pharma Co., Cairo, Egypt). Both agents used in the study will be relabeled by a pharmacist who will not take any part in the study in terms of patients' care, follow-up, data collection/analysis or accessing outcomes. Both topical agents will be placed in identical containers of 60 gm and labeled with blue or red colors. The color code will remain undefined till the end of trial, data analysis, and interpretation of results except for the same pharmacist. The containers will be distributed to the patients by the outpatient's department nurse in the hospital.

Patients will be advised to apply approximately 2 cm of the gel/cream (equal to 3 gm) on the perianal area three times per day for 4 weeks. The first dose of drugs will be given at home on the same day of the first visit. During the first visit, patients will be taught to self-administer the topical gel/cream. The patients will be instructed to take laxatives to avoid constipation and to avoid using other topical preparations during the study period.

Follow-up Patients will be followed in the general and colorectal surgery outpatient clinics for a period of three months. Patients will be advised to visit the outpatient clinic every week for one month, then biweekly in the 2nd and 3rd months after starting treatment. In case of intolerable adverse events patients will be advised to visit the outpatient clinic at any other time point during the trial. At each visit the anal fissure will be inspected and the extent of healing will be assessed by a surgical resident who is unaware of the nature of the study. Patients will be asked about the improvement in their symptoms, particularly anal pain and bleeding. Pain will be measured at each visit by the Visual Analog Scale (VAS) ranging from no pain "0" to worst possible pain "10". Blood pressures will be measured and any decrease of > 15 mmHg from the basal pressure measured at the first visit will be considered significant. Adverse effects induced by the topical agents as itching, headache, palpitation, dizziness, excess perianal hair growth, and hypersensitivity reaction will be recorded. Itching will be assessed by 5-D pruritus scale. The continence state will be assessed using Wexner continence score.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anal Fissure
Intervention  ICMJE
  • Drug: Minoxidil
    application of minoxidil forte 5% gel three time per day on the anus for four weeks
    Other Name: Topical Minoxidil treatment
  • Drug: Glyceryl trinitrate
    application of glyceryl trinitrate 0.2% cream three time per day on the anus for four weeks
    Other Name: Topical GTN treatment
Study Arms  ICMJE
  • Active Comparator: Minoxidil
    Patients in this arm will receive topical treatment with Minoxidil forte 5% gel three times per days for 4 weeks
    Intervention: Drug: Minoxidil
  • Active Comparator: Glyceryl trinitrate
    Patients in this arm will receive topical treatment with glyceryl trinitrate 0.2% cream three times per days for 4 weeks
    Intervention: Drug: Glyceryl trinitrate
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2019)
62
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2018)
70
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients of both genders presenting with chronic anal fissure of more than 6 weeks in duration
  • Ageing between 18 and 65 years old.

Exclusion Criteria:

  • Pregnant patients.
  • Patients with recurrent anal fissure after previous sphincterotomy.
  • Patients with coexisting anorectal diseases or inflammatory bowel diseases.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03528772
Other Study ID Numbers  ICMJE mansoura50
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sameh Emile, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sameh Emile, M.D. Mansoura University
PRS Account Mansoura University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP