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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03920449
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : May 29, 2020
Information provided by (Responsible Party):
Mostafa shalaby, MD, MSc, PhD, Mansoura University

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.

Condition or disease Intervention/treatment Phase
Chronic Anal Fissure Drug: Botulinum Toxins Procedure: Posterolateral internal sphincterotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postero-lateral Internal Sphincterotomy vs Botulinum Toxin Injection in the Treatment of Chronic Anal Fissure: A Randomized Controlled Trial
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
Active Comparator: Botulinum toxin injection 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.

Active Comparator: Posterolateral internal sphincterotomy 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.

Primary Outcome Measures :
  1. healing rate [ Time Frame: six months ]
    re-epithelialization of the anoderm, as well as, resolution of bleeding and pain

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chronic anal fissure lasting more than 6 weeks

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03920449

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Contact: Mostafa Shalaby 00201001645917

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Mansoura University Recruiting
Mansoura, Al Dakhlia, Egypt, 35516
Contact: Mostafa Shalaby    00201001645917   
Sponsors and Collaborators
Mansoura University
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Principal Investigator: Mostafa Shalaby Mansoura University
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Responsible Party: Mostafa shalaby, MD, MSc, PhD, Dr, Mansoura University Identifier: NCT03920449    
Other Study ID Numbers: R/19.02.418
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mostafa shalaby, MD, MSc, PhD, Mansoura University:
Chronic anal fissure
Botulinum toxin
Additional relevant MeSH terms:
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Fissure in Ano
Anus Diseases
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs