Case Control Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Nov 16, 2021; 9(32): 9722-9730
Published online Nov 16, 2021. doi: 10.12998/wjcc.v9.i32.9722
Botulinum toxin associated with fissurectomy and anoplasty for hypertonic chronic anal fissure: A case-control study
Beatrice D'Orazio, Girolamo Geraci, Fausto Famà, Gloria Terranova, Gaetano Di Vita
Beatrice D'Orazio, Girolamo Geraci, Gaetano Di Vita, Department of Surgical, Oncological and Stomatological Sciences, University of Palermo, Palermo 90100, Sicily, Italy
Fausto Famà, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University Hospital of Messina, Messina 98121, Sicily, Italy
Gloria Terranova, Department of Surgical, Oncological and Stomatological Sciences, Postgraduate Medical School in General Surgery, University of Palermo, Palermo 90100, Sicily, Italy
Author contributions: D’Orazio B, Geraci G and Di Vita G conceived, devised and designed the manuscript; Terranova G collected the cases and iconography; D’Orazio B and Geraci G wrote the manuscript and participated in the sequence alignment; Di Vita G and Famà F revised and approved the final manuscript and its conclusions; All authors contributed to the study.
Institutional review board statement: All procedures performed in studies involving human participants were in accordance with the ethical standards of the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The protocol for this study was submitted to the Ethical Committee of our institution “Ethical Committee Palermo 1-AUOP P. Giaccone” on March 1, 2018, which did not consider it necessary to approve it and waved, in that occasion, the requirement for ethical approval.
Informed consent statement: Informed written consent was obtained from all individual participants included in this study.
Conflict-of-interest statement: The authors report no conflicts of interest in this work. The authors declare that they have no competing interests. This article has not been presented or published elsewhere, and no financial support has been obtained for its preparation.
Data sharing statement: The datasets generated and/or analysed during the current study are available from the corresponding author upon reasonable request.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Gaetano Di Vita, MD, Chief Doctor, Professor, Surgeon, Department of Surgical, Oncological and Stomatological Sciences, University of Palermo, U.O. di Chirurgia Generale, Endoscopica, Diagnostica ed Interventistica, Palermo 90100, Sicily, Italy. divitagaetano@libero.it
Received: February 16, 2021
Peer-review started: February 16, 2021
First decision: May 4, 2021
Revised: May 7, 2021
Accepted: August 25, 2021
Article in press: August 25, 2021
Published online: November 16, 2021
ARTICLE HIGHLIGHTS
Research background

Lateral internal sphincterotomy is still the approach of choice for the treatment of chronic anal fissure (CAF) with internal anal sphincter (IAS) hypertonia, but it is burdened by high-risk postoperative faecal incontinence.

Research motivation

Sphincter-saving procedures have been recently reconsidered as treatments to overcome this risk.

Research objectives

The aim of our study was to evaluate whether fissurectomy and anoplasty with botulinum toxin injection improves the results of fissurectomy and anoplasty alone.

Research methods

We conducted a case-control study involving 30 male patients affected by CAF with hypertonic IAS who underwent fissurectomy and anoplasty with V-Y cutaneous flap advancement. The patients were divided into two groups: Those in group I underwent surgery alone, and those in group II underwent surgery and a botulinum toxin injection directly into the IAS. They were followed up for at least 2 years.

Research results

The intensity and duration of post-defecatory pain decreased significantly in both groups of patients starting with the first defecation, and this reduction was higher in group II. Forty days after surgery, we achieved complete wound healing in all the patients in group II but only in 80% of the patients in group I (P < 0.032). We recorded 2 cases of recurrence, one in each group, and both healed with conservative therapy. We recorded one temporary and low-grade postoperative case of “de novo” faecal incontinence. Manometry parameters reverted earlier to the normal range in group II patients.

Research conclusions

The injection of botulinum toxin A in association with fissurectomy and anoplasty with a V-Y advancement flap improves the results of surgery alone in patients affected by CAF with IAS hypertonia.

Research perspectives

Further studies with larger samples of patients are necessary to ensure a greater foundation for our findings. The outcomes of this study might be considered a starting point to consider the sphincter-saving procedure, eventually associated with pharmacological sphincterotomy, as the treatment of choice for all patients affected by chronic anal fissure regardless of the internal anal sphincter tone.