Topical Minoxidil Versus Topical Glyceryl Trinitrate in Treatment of Chronic Anal Fissure
Condition: Anal Fissure
MeSH terms: Fissure in Ano
Study type: Interventional

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.
    

Intervention name(s): Minoxidil; Glyceryl trinitrate
Intervention type(s): Drug; Drug
Intervention description(s): 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
Other intervention name(s): Topical Minoxidil treatment; Topical GTN treatment
Intervention MeSH terms: Minoxidil; Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anal fissure, minoxidil, glycreyl trinitrate