NCT06617026

Short-Term Outcome of Medical Vs. Surgical Management Of Chronic Anal Fissure

Short-Term Outcome of Medical Vs. Surgical Management Of Chronic Anal Fissure (A Randomized Controlled Trial)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Suez Canal University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1\. To evaluate 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 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.

Conditions

• Anal Fissure Chronic

Interventions

Type	Name	Description
DRUG	Sucralfate	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
DRUG	Azadirachtin	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
PROCEDURE	fissurectomy and lateral sphincterectomy	fissurectomy and lateral sphincterectomy

Timeline

• Start date: 2024-08-30
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2024-09-27
• Last updated: 2024-11-08

Locations

1 site across 1 country: Egypt