Postero-lateral Internal Sphincterotomy vs Botulinum Toxin Injection in the Treatment of Chronic Anal Fissure

NCT03920449 | Unknown DMC

• 1 other identifier: R/19.02.418
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesized that optimization of the dose of the Botulinum toxin injection (BT) and standardization of the technique of lateral internal sphincterotomy to posterolateral internal sphincterotomy (PIAS) could, in turn, report a conclusive result which helps to provide better care to patients with chronic anal fissure. So, we will conduct this trial as a prospective randomized, controlled, intervention, open-label trial with two parallel groups, and a primary endpoint of fissure healing during 6 months after the initial intervention, with the randomization, will be performed by an online software with a 1:1 allocation. Eligible patients will be randomized in equal proportions between BT injection and PIAS.

Conditions

Chronic Anal Fissure

Keywords

Chronic anal fissure; Botulinum toxin; Sphincterotomy

Outcome Measures

Primary Outcomes (1)

• healing rate

  re-epithelialization of the anoderm, as well as, resolution of bleeding and pain

  six months

Study Arms (2)

Botulinum toxin injection

ACTIVE COMPARATOR

Drug: Botulinum Toxins

Posterolateral internal sphincterotomy

ACTIVE COMPARATOR

Procedure: Posterolateral internal sphincterotomy

Interventions

Botulinum Toxins DRUG

In group I (BT injection), 21 U will be injected in 3 divided doses through the internal anal sphincter at 3,9, and 12 o'clock. In the Egyptian market two commercial forms are available; botulinum toxin type A (Botox 100 IU/vial; Coolock, Dublin, Ireland), and abobotulinumtoxin A (Dysport 500 U/vial; Ipsen Biopharm Ltd, Wrexham, UK). In case of Dysport it should be remembered that dosing is on a ratio of approximately 1 to 3, meaning that 50 IU of Botox have the same effect as 150 IU of Dysport.

Botulinum toxin injection

Posterolateral internal sphincterotomy PROCEDURE

In group II (PIAS), A 1.5 to 2-cm circumferential skin incision will be placed at 5 o'clock position outside the anal verge using an electrocautery device. Dissection will be proceeded through the intersphincteric groove to separate both IAS and external anal sphincter (EAS). Then, the IAS will be identified by its characteristic white fibers, separated from the anal mucosa, and assessed under direct vision. Subsequently, about 50 % of the IAS will be divided at 5 o'clock position and any skin tags or hypertrophied anal papillae will be removed leaving the skin incision open to allow drainage.

Posterolateral internal sphincterotomy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chronic anal fissure lasting more than 6 weeks

You may not qualify if:

• Pregnant
• cardiovascular disease or heart failure
• on antihypertensive medications
• recurrent anal fissure after previous sphincterotomy
• prior history of anal surgery
• other benign anorectal diseases
• with inflammatory bowel diseases

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Al Dakhlia, 35516, Egypt

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Mostafa Shalaby

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mostafa Shalaby

CONTACT

00201001645917; mostafashalaby@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 18, 2019
• Study Start: May 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)