Comparison of the results of chronic anal fissure surgery between conventional internal partial sphincterotomy and tailored sphincterotomy of string suture anoscope
Comparison of the results of chronic anal fissure surgery between conventional internal partial sphincterotomy and tailored sphincterotomy of string suture anoscope
Design
A single-blind, randomized clinical trial study with parallel groups and phases 3 on 60 patients. Randomization will be done with the block randomization method using Random allocation software.
Settings and conduct
This study will be conducted in patients with chronic anal fissure undergoing surgery inUrmiaImam Khomeini Hospital.Patients will be randomly assigned to one of two groups: conventional partial internal sphincterotomy or tailored sphincterotomy. The study will be a single-blinded study.
Participants/Inclusion and exclusion criteria
Patients with a history of chronic anal fissure lasting more than one month will be included in the study. The main exclusion criteria will be acute fissures, coexicted fissure with fistula or inflammatory bowel disease, a history of systemic diseases, a history of anal surgery (for fissure, fistula, or hemorrhoids), fecal incontinence.
Intervention groups
Patients will be randomly assigned via block randomization into Conventional partial internal sphincterotomy or tailored sphincterotomy. In conventional Sphincterotomy, 30% of the exposed internal sphincter will be cut. The incision site will be repaired with absorbable sutures and dressed. In tailored Sphincterotomy group , a No. 34 purse-string anoscope will be inserted and rotated circumferentially. Any areas of tightness will be incised using electrocautery. The fissure will be assessed, and thickened edges or apical skin tags (if present) will be excised. The surgeon will ensure that the electrocautery does not extend beyond the dentate line. The extent of sphincterotomy will be precisely adjusted based on fissure height.
Main outcome variables
Complete treatment of Fischer; fecal incontinence, gas incontinence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210919052515N6
Registration date:2025-06-20, 1404/03/30
Registration timing:prospective
Last update:2025-06-20, 1404/03/30
Update count:0
Registration date
2025-06-20, 1404/03/30
Registrant information
Name
Naser Masoudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3337 9924
Email address
masoudi.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-23, 1404/05/01
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results of chronic anal fissure surgery between conventional internal partial sphincterotomy and tailored sphincterotomy of string suture anoscope
Public title
Comparison of the two methids of conventional internal partial sphincterotomy and tailored sphincterotomy of string suture anoscope in chronic anal fissure surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 old years
Chronic anal fissure lasting more than one month
Exhibiting signs of chronicity upon anal examination such as the presence of a skin tag
Vsible fibers of the internal anal sphincter at the base of the wound
Exclusion criteria:
Patients with acute fissures
Coexicted fissure with fistula or inflammatory bowel disease
A history of systemic diseases
A history of anal surgery (for fissure, fistula, or hemorrhoids)
Fecal incontinence
Perineal tears following delivery
Prior radiotherapy
Use of corticosteroids or other immunosuppressive drugs
pregnant women
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two methods of surgery using block randomization based on generated numbers by random allocation software. So that, in this software, the number of groups and the total number of the sample size will be entered and then in the block section, the block randomization method will be implemented. Patients will be allocated to two groups based on generated numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be conducted as a single-blind clinical trial. The patient will be blinded about surgery methods.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Imam Khomeini Hospital, Urmia University of Medical Sciences
Weeks one, four, eight, and 6 months after surgery
Method of measurement
Clinical examination
2
Description
Gas incontinence
Timepoint
Weeks one, four, eight, and 6 months after surgery
Method of measurement
Questioning the patient
3
Description
Fecal incontinence
Timepoint
Weeks one, four, eight, and 6 months after surgery
Method of measurement
Questioning the patient
Secondary outcomes
1
Description
Pain score
Timepoint
After surgery during recovery
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Dosage of analgesia
Timepoint
24 hours after surgery
Method of measurement
Milligram
Intervention groups
1
Description
Intervention group: In tailored Sphincterotomy group , a No. 34 purse-string anoscope will be inserted and rotated circumferentially. Any areas of tightness will be incised using electrocautery. The fissure will be assessed, and thickened edges or apical skin tags (if present) will be excised. The surgeon will ensure that the electrocautery does not extend beyond the dentate line. The extent of sphincterotomy will be precisely adjusted based on fissure height.
Category
Treatment - Surgery
2
Description
Control group: . In conventional partial Sphincterotomy, 30% of the exposed internal sphincter will be cut. The incision site will be repaired with absorbable sutures and dressed.