Back to resultsComparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
Primary Purpose
Fissure in Ano
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Botulinum injection
GTN OINTMENT
Sponsored by
About this trial
This is an interventional treatment trial for Fissure in Ano focused on measuring Fissure, botulinum toxin, Gtn ointment
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
Sites / Locations
- Pak-Emirates Military HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Botulinum group
GTN group
Arm Description
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)
0.2 percent nitroglycerin ointment applied twice daily for six weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05590520
First Posted
October 14, 2022
Last Updated
March 27, 2023
Sponsor
Pak Emirates Military Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05590520
Brief Title
Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
Official Title
A Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure :A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pak Emirates Military Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fissure in Ano
Keywords
Fissure, botulinum toxin, Gtn ointment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botulinum group
Arm Type
Experimental
Arm Description
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)
Arm Title
GTN group
Arm Type
Active Comparator
Arm Description
0.2 percent nitroglycerin ointment applied twice daily for six weeks.
Intervention Type
Procedure
Intervention Name(s)
Botulinum injection
Other Intervention Name(s)
Botox inj
Intervention Description
Botox injection to be injected in internal anal sphincter to see the curative response in comparison to gtn cream application
Intervention Type
Drug
Intervention Name(s)
GTN OINTMENT
Other Intervention Name(s)
0. 2% GTN
Intervention Description
0.2%GTN applied on anal canal.
Primary Outcome Measure Information:
Title
Healing of fissure
Description
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.
Time Frame
Within 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mubashra Badar
Phone
03145274242
Email
mubashrabadar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mubashra Badar
Organizational Affiliation
Resident
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pak-Emirates Military Hospital
City
Rawalpindi
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mubashra Badar, MBBS, FCPS
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
I'll publish the article and all data will be available for researchers
IPD Sharing Time Frame
Data will be available once published and will also be available as open source review
IPD Sharing Access Criteria
All researchers will be allowed to buildup on this research.
Learn more about this trial
Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure
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