A Phase 1/2 interventional study of Sucralfate and Azadirachtin in Anal Fissure Chronic, sponsored by Suez Canal University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Suez Canal University · Phase 1/2, Interventional, and Treatment
Several topical agents have been proposed for Chronic anal fissure (CAF) treatment with the common goal of increasing anodermal blood flow to promote healing but approaching the use of medical treatment in CAFs is not standardized yet. Thus, the present study aimed to compare the efficacy and safety of Sucralfate (Emoflon®), the combination of azadirachtin and hyperforin (HyperOil®) and the traditional surgical treatment (lateral sphincterotomy) in patients with CAFs.
Several topical agents have been proposed for Chronic anal fissure (CAF) treatment with the common goal of increasing anodermal blood flow to promote healing but approaching the use of medical treatment in CAFs is not standardized yet. Thus, the present study aimed to compare the efficacy and safety of Sucralfate (Emoflon®), the combination of azadirachtin and hyperforin (HyperOil®) and the traditional surgical treatment (lateral sphincterotomy) in patients with CAFs.
Study Objective:
Primary Objectives:
Study Design:
A prospective randomized controlled trial
Study sampling:
A convenience sampling method will be used; all patients seeking medical advice for CAF at Suez Canal University hospitals, the Faculty of Medicine during the study period and fulfill the inclusion criteria will be recruited. One of the researchers who will make random allocation cards using an Excel formula algorithm will perform simple randomisation.
Methodology:
This study will include at least 99 patients with CAFs of both genders who will visit the general surgery clinic in the faculty of medicine at Suez Canal University hospital and fulfil the inclusion and exclusion starting from September 2024. Patients of both genders with CAF for the first time, above 18 years old and ASA I/II will be included in the study. While patients with sepsis, previous pelvic radiation, recurrent CAF, with malignancy, on immunosuppressive drugs, with pregnancy or lactation will be excluded. Patients will be randomly allocated into 3 groups at a ratio of 1:1:1 starting with the Sucralfate group. Formal written consent will be obtained from the study participants prior to being involved in the study. All included patients will be followed up to 40 days.
79 studies on the registry are indexed under Fissure in Ano; 14 are open to participants now.
This study's enrollment of 99 is close to the median of 99 across 61 interventional studies indexed under Fissure in Ano.
Browse Fissure in Ano studies →Suez Canal University is the lead sponsor of 157 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
patients assigned to this group will start to use a topical rectal ointment containing Sucralfate. The patients are instructed to apply it twice a day, using a gloved finger, inside the anal canal and the perianal region for 40 days. the follow-up visits are arranged at 15, 30 and 40 days.
Drug: Sucralfate
patients assigned to this group will start to use topical oil containing the combination of azadirachtin and hyperforin. The patients are instructed to apply it twice a day, using a gloved finger, inside the anal canal and the perianal region for 40 days. the follow-up visits are arranged at 15, 30 and 40 days.
Drug: Azadirachtin
patients assigned to this group will be operated for fissurectomy and lateral sphincterectomy. the follow-up visits are arranged at 15, 30 and 40 days.
Procedure: fissurectomy and lateral sphincterectomy
a topical rectal ointment. The patients are instructed to apply it twice a day, using a gloved finger, inside the anal canal and the perianal region for 40 days
a topical oil. The patients are instructed to apply it twice a day, using a gloved finger, inside the anal canal and the perianal region for 40 days
Also known as: azadirachtin and Hyperforin
fissurectomy and lateral sphincterectomy
REALISE score
REALISE (scoRing systEm for AnaL fIsSurE), will be used to assess pain (score range 0-10), quality of life, duration of pain, intake of analgesics and bleeding. The latter four items were rated on a scale of 1-5
Time frame: in each 3 follow up visits (visit 1,2, and 3 after 15, 30 , and 40 days respectively)
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Suez Canal University