Anal Fissure Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Adults aged 18 to 65 years, regardless of sex Diagnosis of chronic anal fissure persisting for more than 6 weeks Failure of at least 6 weeks of standardized conservative treatment Fit for anesthesia and surgical intervention Willing and able to provide written informed consent

Locations
Other Locations
Pakistan
Islamabad Medical and Dental College
RECRUITING
Islamabad
Contact Information
Primary
Prof. Dr. Rizwan Aziz
aziz.rizwan@imdcollege.edu.pk
+923008444229
Backup
Prof. Dr. Asma Irfan
asma.irfan@imdcollege.edu.pk
+923215016605
Time Frame
Start Date: 2026-06-03
Estimated Completion Date: 2026-12-03
Participants
Target number of participants: 108
Treatments
Experimental: Injection Botox Alone
Participants in this arm will receive injection of 30 IU botulinum toxin type A into the internal anal sphincter at the 3 and 9 o'clock positions (15 IU at each site). The procedure will be performed under appropriate anesthesia according to the study protocol. Participants will undergo scheduled follow-up assessments for healing, pain relief, recurrence, continence, complications, and patient satisfaction.
Active_comparator: Injection Botox Plus Fissurectomy and Anoplasty
Participants in this arm will receive injection of 30 IU botulinum toxin type A into the internal anal sphincter followed by fissurectomy and advancement flap anoplasty. Fissurectomy will involve excision of the chronic fissure and associated fibrotic tissue, including sentinel skin tag and hypertrophied anal papilla when present. Advancement flap anoplasty will then be performed to cover the defect with well-vascularized tissue. Participants will undergo scheduled follow-up assessments for healing, pain relief, recurrence, continence, complications, and patient satisfaction.
Related Therapeutic Areas
Sponsors
Leads: Islamabad Medical and Dental College

This content was sourced from clinicaltrials.gov