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

NCT06617026 | Completed Phase 1

• 1 other identifier: #5787
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Fissure Chronic

Keywords

Chronic anal fissure

Outcome Measures

Primary Outcomes (1)

• 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

  in each 3 follow up visits (visit 1,2, and 3 after 15, 30 , and 40 days respectively)

Study Arms (3)

Sucralfate Group

EXPERIMENTAL

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

HyperOil Group

EXPERIMENTAL

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

Surgery

ACTIVE COMPARATOR

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

Interventions

Sucralfate 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

Sucralfate Group

Azadirachtin 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

Also known as: azadirachtin and Hyperforin

HyperOil Group

fissurectomy and lateral sphincterectomy PROCEDURE

fissurectomy and lateral sphincterectomy

Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

MeSH Terms

Interventions

Sucralfate; azadirachtin; hyperforin

Intervention Hierarchy (Ancestors)

Thioglycosides; Sulfur Compounds; Organic Chemicals; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant and lecturer of General surgery

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 27, 2024
• Study Start: August 30, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Locations

EG (1)