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

Sponsor

Pak Emirates Military Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05590520

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fissure in Ano	Procedure: Botulinum injection Drug: GTN OINTMENT	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure :A Randomized Controlled Trial

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Procedure: Botulinum injection Botox injection to be injected in internal anal sphincter to see the curative response in comparison to gtn cream application Other Names: Botox inj
Active Comparator: GTN group 0.2 percent nitroglycerin ointment applied twice daily for six weeks.	Drug: GTN OINTMENT 0.2%GTN applied on anal canal. Other Names: 0. 2% GTN

Arm

Intervention/Treatment

Experimental: 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)

Procedure: Botulinum injection

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

Other Names:

Botox inj

Active Comparator: GTN group

0.2 percent nitroglycerin ointment applied twice daily for six weeks.

Drug: GTN OINTMENT

0.2%GTN applied on anal canal.

Other Names:

0. 2% GTN

Outcome Measures

Primary Outcome Measures

Healing of fissure [Within 6 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Pak Emirates Military Hospital

Investigators

Principal Investigator: Mubashra Badar, Resident

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mubashra Badar, Resident, Pak Emirates Military Hospital

ClinicalTrials.gov Identifier:

NCT05590520

Other Study ID Numbers:

FIS 1cpsp

First Posted:

Oct 21, 2022

Last Update Posted:

Oct 21, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mubashra Badar, Resident, Pak Emirates Military Hospital

Fissure, botulinum toxin, Gtn ointment

Additional relevant MeSH terms:

Fissure in Ano

Study Results

No Results Posted as of Oct 21, 2022