Determining the effect of amniotic membrane on anal fissure wound healing
Design
This randomized- controlled parallel, open label clinical trial study will be conducted on 110 patients. the randomization will be dome using Random allocation software.
Settings and conduct
In this open label clinical trial, patients with anal fissure wound will be enrolled. The patients will be divided randomly into two groups. In the intervention group, in addition to standard sphincterotomy surgery, two Cm2 of amniotic membrane prepared from the stem cell center of the Tehran University will be sutured to the margin of the anal fissure wound. In the control group, only standard sphincterotomy surgery will be performed.
Participants/Inclusion and exclusion criteria
This study will be conducted on patients suffering anal fissure. The exclusion criteria will be including Inflammatory bowel disease; past medical history of previous anal surgeries; BMI>30 kg/m2; and autoimmune diseases.
Intervention groups
In the intervention group, in addition to standard sphincterotomy surgery, two Cm2 of amniotic membrane prepared from the stem cell center of the Tehran University will be sutured to the margin of the anal fissure wound. In the control group, only standard sphincterotomy surgery will be performed.
Main outcome variables
The wound healing rate; anal pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210919052515N3
Registration date:2022-02-13, 1400/11/24
Registration timing:prospective
Last update:2022-02-13, 1400/11/24
Update count:0
Registration date
2022-02-13, 1400/11/24
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
2022-02-20, 1400/12/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the amniotic membrane effect on healing of anal fissure wound after surgery
Public title
Assessment of the amniotic membrane effect in anal fissure wound
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with anal fissures
Patients with no recovery despite treatment with fiber, topical ointment and hot tub for more than 3 weeks
Having pain during defecation
Exclusion criteria:
History of inflammatory bowel disease
Past medical history of previous anal surgeries
BMI>30 kg/m2
Autoimmune diseases
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into intervention and control groups using block randomization based on generated numbers by random allocation software. Thus, in this software, first 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 selected. Patients will be allocated in intervention or control groups based on generated numbers.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Resalat street, Jahad Blvd., Urmia, Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2021-11-10, 1400/08/19
Ethics committee reference number
IR.UMSU.REC.1400.354
Health conditions studied
1
Description of health condition studied
Fissure wound
ICD-10 code
K60
ICD-10 code description
Fissure and fistula of anal and rectal regions
Primary outcomes
1
Description
Wound healing
Timepoint
1, 2, 3 and 4 weeks after surgery
Method of measurement
Clinical examination
2
Description
Duration of pain
Timepoint
Up to 4 weeks after surgery
Method of measurement
The number of days with pain
Secondary outcomes
1
Description
Wound infection
Timepoint
1, 2, 3 and 4 weeks after surgery
Method of measurement
Clinical examination
2
Description
Pruritus of wound
Timepoint
1, 2, 3 and 4 weeks after surgery
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: in addition to standard sphincterotomy surgery, two Cm2 of amniotic membrane prepared from the stem cell center of the Tehran University will be sutured to the margin of the anal fissure wound
Category
Treatment - Other
2
Description
In the control group, only standard sphincterotomy surgery will be performed.