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

NCT ID: NCT05590520

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

Lateral internal sphincterotomy, the most common treatment for chronic anal fissure, may cause permanent injury to the anal sphincter, which can lead to fecal incontinence. We compared two nonsurgical treatments that avert the risk of fecal incontinence.treatment with either topical nitroglycerin or botulinum toxin is effective as an alternative to surgery

Conditions

Fissure in Ano

Study Design

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

Study Groups

Botulinum group

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)

Group Type: EXPERIMENTAL

Botulinum injection

Intervention Type: PROCEDURE

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

GTN group

0.2 percent nitroglycerin ointment applied twice daily for six weeks.

Group Type: ACTIVE_COMPARATOR

GTN OINTMENT

Intervention Type: DRUG

0.2%GTN applied on anal canal.

Interventions

Botulinum injection

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

Intervention Type: PROCEDURE

GTN OINTMENT

0.2%GTN applied on anal canal.

Intervention Type: DRUG

Other Intervention Names

Botox inj; 0. 2% GTN

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pak Emirates Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mubashra Badar

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mubashra Badar

Role: PRINCIPAL_INVESTIGATOR

Resident

Locations

Pak-Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Mubashra Badar

Role: CONTACT

mubashrabadar@gmail.com

03145274242

Facility Contacts

Mubashra Badar, MBBS, FCPS

Role: primary

Other Identifiers

FIS 1cpsp

Identifier Type: -

Identifier Source: org_study_id