Clinical trial NCT06617026: Short-Term Outcome of Medical Vs. Surgical Management Of Chronic Anal Fissure
Official title: Short-Term Outcome of Medical Vs. Surgical Management Of Chronic Anal Fissure (A Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anal Fissure Chronic
Keywords: Chronic anal fissure
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: REALISE score
timeFrame: in each 3 follow up visits (visit 1,2, and 3 after 15, 30 , and 40 days respectively)
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
References: