High Dose Multiple Site Injection of Botox Versus Lateral Sphincterotomy in Chronic Analfissure (professor)

Treatment of Chronic Anal Fissure, Lateral Internal Sphincterotomy Versus Local Injection of High Dose Botulinum Toxin: A Randomized Clinical Trial

comparison between the effect of lateral sphincterotomy against high dose botox injection in chronic anal fissure the outcome was healing time, recurrence continence relapse pain pruritus

Study Overview

• Status: Completed
• Conditions: Chronic Anal Fissure
• Intervention / Treatment: Procedure: botox injection in intersphincteric space; Procedure: lateral internal sphincterotomy

Detailed Description

This randomized comparative clinical trial was carried out over 2 year in the period between January 2018 and December 2019 on total number of 96 patients suffering chronic anal fissure the participants were randomly allocated into two groups each 48 patients ; group (1) the botulinum ( Botox) group, they were subjected to 80 IU Botox injection as an intervention for treatment of chronic anal sphincter, and group 2 the sphincterotomy group, underwent internal sphincterotomy as a surgical intervention for treatment of chronic anal fissure.

The study was approved by the institutional review board and the local ethical committee of our university hospital The condition of the current study is chronic anal fissure defined as the presence of anterior or posterior chronic anal wound with skin tag at its lower end and hypertrophied anal papilla at its upper end with induration around its edges in patients complaining of anal pain, constipation, and/or fresh anal bleeding for at least two months.

Randomization was achieved using computer generated cards. Inclusion criteria; patients suffering chronic anal fissure aged above 16 years old Exclusion criteria; those with previous anal surgery, complicated anal fissure, unfit for surgery, specific disease as Crohn's disease and ulcerative colitis, malignancy, anal fistula or abscess those with systemic disease requiring treatment with calcium channel blockers and /or nitrates Patients of both groups were subjected to thorough history taking, clinical examination, digital rectal examination and anorectal manometry for diagnosis of chronic anal fissure and exclusion of any other anal condition and incontinence, patient signed an informed written consent, routine preoperative investigations performed as usual.

Interventions;

1. Botulinum toxin (Botox) injection; was performed under general anesthesia in the lithotomy position, where 80 IU of Botox was injected in four positions each 20 IU namely in 5, 7, 11, and 1 O'clock positions in the intersphincteric space not deeper than the midpoint of the anal canal.
2. Lateral internal sphincterotomy; was performed under general anesthesia where the lower part of the internal sphincter was cut by electrocautery on the left lateral position to an extent not beyond the proximal end of the fissure, the sentinel pile was also removed.

After the procedure patients were advised for bulking agents, stool softener, and sitz baths The follow up was carried out in the outpatient clinic by the attending surgeon (not a study participant) after 1 week then 1, 2, 3, 6, 9 and 12 months post-procedure.

The primary outcome of the current study is complete healing of the chronic anal fissure, recurrence in the follow up time, and development of incontinence, incontinence is described as in (the Cleveland Clinic Florida-Fecal Incontinence (CCF-FI) scoring system), which contains 5 questions on solid and liquid stool leakage, gas leakage, pad use, and lifestyle restriction. the secondary outcome is postoperative or post-injection pain measured by visual analogue scale (VAS) and the time taken for complete healing of fissure (defined as complete epithelialization of the fissure).

Demographic data, presentation data, follow up data including primary and secondary outcome all collected and analyzed properly using t test, chi square test, and Z test in SPSS program 22 version.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sharqya
    • Zagazig, Sharqya, Egypt, 44519
      • Zagazig Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients suffering chronic anal fissure aged above 16 years old

Exclusion Criteria:

• those with previous anal surgery,
• complicated anal fissure,
• unfit for surgery,
• specific disease as Crohn's disease and ulcerative colitis,
• malignancy,
• anal fistula or abscess
• those with systemic disease requiring treatment with calcium channel blockers and /or nitrates

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1 botox group; 48 patients subjected to 80 IU botox injection under GAin lithotomy position in the 5,7,11, and 1 O'clock positions	Procedure: botox injection in intersphincteric space; injection of 80 IU of botox in the intersphincteric space in 5,7,11 and 1 O'clock position
Active Comparator: group 2 lateral sphincterotomy group; 48 patients subjected to lateral internal sphincterotomy under GAin lithotomy position	Procedure: lateral internal sphincterotomy; lateral internal sphincterotomy under GA in lithotomy position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete healing of fissure	complete epithelialization of the floor of the chronic anal wound achieved through clinical examination at follow up visits	2 months
loss of anal continence	inability to control stool or flatus measured by modified wexner score questionaire	1 week
recurrence	the anal fissure reformed again after complete healing measured by clinical examination	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time taken for complete healing	time taken for complete epithelialization of the anal wound measured by clinical examination	1 year
post operative pain	pain in the postoperative time measured by visual analogue scale	1 month

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): May 30, 2019

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 19, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Anus Diseases; Fissure in Ano
• Other Study ID Numbers: anal sphincterotomy or botox

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No