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

NCT03920449 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-05-29

No results posted yet for this study

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

Interventions

DRUG

Botulinum Toxins

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.

PROCEDURE

Posterolateral internal sphincterotomy

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mostafa Shalaby · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-12-01
Completion
2021-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03920449 on ClinicalTrials.gov