Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure

NCT05590520 | Unknown

• 1 other identifier: FIS 1cpsp
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will be randomized to receive treatment with either a total of 20 U of botulinum toxin(diluted in saline to a concentration of 50 U per milliliter.

Conditions

Fissure in Ano

Keywords

Fissure, botulinum toxin, Gtn ointment

Outcome Measures

Primary Outcomes (1)

• Healing of fissure

  All the patients will undergo a pretreatment evaluation that will include clinical inspection of the fissure based on evidence of posterior circumscribed ulcer, with a large sentinel tag of skin, induration at the edges, and exposure of the horizontal fibers of the internal anal sphincter and symptoms including post-defecatory or nocturnal pain, bleeding, or both. Then they will be randomized to receive treatment with either botulinum toxin or 0.2 percent nitroglycerin ointment applied twice daily for six weeks. The outcome in each group will be evaluated clinically.The end point of the study would be complete healing after treatment. The treatment will be considered successful if the fissure healed. Persistence of the fissure in the absence of symptoms will be considered as symptomatic improvement.The Secondary endpoints will measurement of post defecatory pain on Visual analogue scale (VAS) at each visit.

  Within 6 weeks

Study Arms (2)

Botulinum group

EXPERIMENTAL

The internal anal sphincter to be palpated and injected with a 27-gauge needle while the patient lying on his or her left side. Each patient will receive 0.4 ml of solution containing botulinum toxin (for a total of 20 U), administered as two injections of equal volume (0.2 ml), one on each side of the anterior midline of the internal anal sphincter. No sedation or local anesthesia to be used during the procedure)

Procedure: Botulinum injection

GTN group

ACTIVE COMPARATOR

0.2 percent nitroglycerin ointment applied twice daily for six weeks.

Drug: GTN OINTMENT

Interventions

Botulinum injection PROCEDURE

Botox injection to be injected in internal anal sphincter to see the curative response in comparison to gtn cream application

Also known as: Botox inj

Botulinum group

GTN OINTMENT DRUG

0.2%GTN applied on anal canal.

Also known as: 0. 2% GTN

GTN group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis: evidence of posterior circumscribed ulcer, with a large sentinel tag of skin, induration at the edges, and exposure of the horizontal fibers of the internal anal sphincter
• symptoms (post-defecatory or nocturnal pain, bleeding, or both) lasting for more than two months.

You may not qualify if:

• Patients with acute fissure
• fissure associated with other conditions (i.e., inflammatory bowel diseases, HIV infection, hemorrhoids, fistula in ano, anal abscesses, or anal or perianal cancer)
• those who had undergone previous surgical procedures in the anal canal.
• known hypersensitivity to component of the formulations of type A BTX
• pregnant or breast-feeding women 6-refusal of consent

Sponsors & Collaborators

• Pak Emirates Military Hospital: lead

Study Sites (1)

Pak-Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Fissure in Ano

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mubashra Badar

  Resident

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mubashra Badar

CONTACT

03145274242; mubashrabadar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 21, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available once published and will also be available as open source review
• Access Criteria: All researchers will be allowed to buildup on this research.

Locations

PA (1)