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

NCT ID: NCT04166175

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-05-30

Brief Summary

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

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.

Conditions

Chronic Anal Fissure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

botox injection in intersphincteric space

Intervention Type: PROCEDURE

injection of 80 IU of botox in the intersphincteric space in 5,7,11 and 1 O'clock position

group 2 lateral sphincterotomy group

48 patients subjected to lateral internal sphincterotomy under GAin lithotomy position

Group Type: ACTIVE_COMPARATOR

lateral internal sphincterotomy

Intervention Type: PROCEDURE

lateral internal sphincterotomy under GA in lithotomy position

Interventions

botox injection in intersphincteric space

injection of 80 IU of botox in the intersphincteric space in 5,7,11 and 1 O'clock position

Intervention Type: PROCEDURE

lateral internal sphincterotomy

lateral internal sphincterotomy under GA in lithotomy position

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hazem Nour Abdellatif

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zagazig Faculty of Medicine

Zagazig, Sharqya, Egypt

Countries

Egypt

Other Identifiers

anal sphincterotomy or botox

Identifier Type: -

Identifier Source: org_study_id