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

NCT ID: NCT06617026

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-30
• Study Completion Date: 2024-10-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sucralfate Group

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.

Group Type: EXPERIMENTAL

Sucralfate

Intervention Type: DRUG

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

HyperOil Group

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.

Group Type: EXPERIMENTAL

Azadirachtin

Intervention Type: DRUG

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

Surgery

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.

Group Type: ACTIVE_COMPARATOR

fissurectomy and lateral sphincterectomy

Intervention Type: PROCEDURE

fissurectomy and lateral sphincterectomy

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

fissurectomy and lateral sphincterectomy

fissurectomy and lateral sphincterectomy

Intervention Type: PROCEDURE

Other Intervention Names

azadirachtin and Hyperforin

Eligibility Criteria

Inclusion Criteria

• above 18 years old.
• CAFs for the first time
• ASA I, II

Exclusion Criteria

• Sepsis
• Previous pelvic radiation.
• recurrent chronic anal fissure
• Pregnancy or lactation.
• Immunosuppressive state
• Malignancy
• Refusal to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Waleed Ghareeb

Senior consultant and lecturer of General surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Suez Canal University

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

#5787

Identifier Type: -

Identifier Source: org_study_id