to compare The rate of fissure healing and recurrence and the extent of pain and suffering in two groups of patients with chronic fissure by two surgical methods with cutaneous advancement flap and mucosal advancement flap
Design
This study is a single-blind randomized clinical trial on 30 patients divided into two equal groups and records patient demographics, postoperative pain scores using the Visual Analogue Scale (VAS) method, and Complications and results are reviewed prospectively
Settings and conduct
The study of a single-blind randomized clinical trial on patients with chronic anal fissure referred to Imam Khomeini Hospital. Cutaneous advancement flap and mucosal advancement flap surgery for chronic fissure were performed on two groups of patients who were randomly divided.
Participants/Inclusion and exclusion criteria
diagnosed with chronic anal fissure and not responding to medication therapy and a candidate for surgery
Intervention groups
Intervention groups 1: Surgery of patients with anal fissure by Cutaneous advancement flap method
Intervention groups 2: Surgery of patients with anal fissure by mucosal advancement flap method
Main outcome variables
The rate of the healing and recurrence of fissures and the evaluation of the pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120129008861N4
Registration date:2022-01-23, 1400/11/03
Registration timing:registered_while_recruiting
Last update:2022-01-23, 1400/11/03
Update count:0
Registration date
2022-01-23, 1400/11/03
Registrant information
Name
Mohammad Reza Keramati
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1657
Email address
mr-keramati@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cutaneous advancement flap and mucosal advancement flap as a surgical treatment for chronic anal fissure
Public title
Comparison of cutaneous advancement flap and mucosal advancement flap as a surgical treatment for chronic anal fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a chronic anal fissure that has not responded to drug treatment and is a candidate for surgery
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple Randomization;
Random unit: Individual;
Randomization tool: excel
Randomization tool output: The patient enters the surgical group with cutaneous advancement flap or mucosal advancement flap.
Blinding (investigator's opinion)
Single blinded
Blinding description
30 patients with chronic anal fissure are randomly divided into two groups: cutaneous advancement flap and mucosal advancement flap surgery. This study is a randomized clinical trial.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences ethics committee
Street address
Tehran University of Medical Sciences, Poursina Avenue, Qods Street, Enqelab Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2021-05-19, 1400/02/29
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.058
Health conditions studied
1
Description of health condition studied
chronic anal fissure
ICD-10 code
K60.1
ICD-10 code description
Chronic anal fissure
Primary outcomes
1
Description
Chronic anal fissure
Timepoint
Postoperative pain and bleeding 1 day, 1 week, 1 month after surgery
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: surgery with cutaneous advancement flap
Category
Treatment - Surgery
2
Description
Second Intervention group: surgery with mucosal advancement flap