A Comparison of Injections of Botulinum Toxin and Topical Nitroglycerin Ointment for the Treatment of Chronic Anal Fissure :A Randomized Controlled Trial
Status: Unknown
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Pakistan
Pak-Emirates Military Hospital
RECRUITING
Rawalpindi
Contact Information
Primary
Mubashra Badar
mubashrabadar@gmail.com
03145274242
Time Frame
Start Date: 2022-11-01
Completion Date: 2024-12
Participants
Target number of participants: 90
Treatments
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)
Active_comparator: GTN group
0.2 percent nitroglycerin ointment applied twice daily for six weeks.
Related Therapeutic Areas
Sponsors
Leads: Pak Emirates Military Hospital