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Comparative Outcomes of Inj Botox Alone vs Inj Botox Combined With Fissurectomy and Anoplasty in the Management of Chronic Anal Fissure

NCT07665528 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-06-26

No results posted yet for this study

Summary

Chronic anal fissure is a common benign anorectal condition characterized by severe pain during defecation, rectal bleeding, and reduced quality of life. Injection Botox is a widely used sphincter-preserving treatment that produces temporary relaxation of the internal anal sphincter and promotes fissure healing. However, healing rates with injection Botox alone are variable and recurrence remains a concern.

This prospective comparative trial aims to compare the effectiveness and safety of injection Botox alone versus injection Botox combined with fissurectomy and anoplasty in adults with chronic anal fissure. The study will evaluate healing rate, pain relief, time to healing, recurrence, postoperative complications, continence outcomes, and patient satisfaction.

A total of 108 eligible patients with chronic anal fissure will be enrolled and allocated to one of the two treatment groups. Participants will be followed after treatment to assess clinical outcomes. The results of this study are expected to provide evidence regarding the optimal sphincter-preserving treatment approach for chronic anal fissure and help improve patient care and quality of life.

Conditions

  • Anal Fissure Chronic

Interventions

DRUG

Botulinum Toxin Type A (BOTOX) Injection

Botulinum toxin type A will be administered as a 30 IU injection into the internal anal sphincter under appropriate anesthesia. The dose will be divided equally between the 3 o'clock and 9 o'clock positions (15 IU at each site) to produce temporary chemical sphincterotomy and reduce sphincter hypertonia associated with chronic anal fissure.

PROCEDURE

Botulinum Toxin Type A (BOTOX) Injection, Fissurectomy and Anoplasty

Following injection Botox, fissurectomy will be performed by excising the fibrotic edges of the chronic anal fissure, sentinel skin tag, and hypertrophied anal papilla when present until healthy vascularized tissue is exposed. Advancement flap anoplasty will then be performed by mobilizing a well-vascularized anodermal or cutaneous flap and advancing it to cover the defect without tension. The flap will be secured using absorbable sutures.

Sponsors & Collaborators

  • Islamabad Medical and Dental College

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-06-03
Primary Completion
2026-09-03
Completion
2026-12-03

Countries

  • Pakistan

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 NCT07665528 on ClinicalTrials.gov