Comparing the results and complications of chronic anal fissure surgery between open and closed surgical sphincterotomy
Design
In this prospective randomized clinical trial performed in Arak Valiasr hospital, all patients with chronic anal fissure who failed to respond to medical therapy after two weeks will be included and those who have recurrent chronic anal fissure or concomitant anorectal disease including anal fistula, abcess and malignancy, inflammatory bowell disease or those who fail to return for follow up are excluded.patients will be assigned into two groups. patients in first group will undergo closed partial lateral internal sphincterotomy and patients in secound group will undergo open partial lateral internal sphincterotomy. cure rate and complications including post operative pain, hemorrhage and infection are recorded and patients will be followed for six mounths.
Settings and conduct
In this study which will be performed in Arak Valiasr hospital, first group of patients will undergo closed partial lateral internal sphincterotomy. In this prosedure while nondominant index finger of surgeon is inserted in anal canal, number eleven surgical blade is inserted at dermal-anodermal junction distal to dentate line at three o'clock lithotomy position, then blade is rotated laterally and retracted with fourty five degrees lateral deviation. patients in the secound group will undergo open surgery. In this procedure an incision, half to one centimeters long, is made on dermal-anodermal junction in inter sphincteric plane and internal sphincter is delivered to wound using a curved hemostat clamp and one third to one half of sphincter bulk is incised and the remainder is released to retract. In both procedures, sufficiency of sphincterotomy and intactness of rectal mucosa is ascertained by digital examination and wound is hemostased and closed with chromic 00 sutures.
Participants/Inclusion and exclusion criteria
All patients with chronic anal fissure will be included; Patients who have recurrent chronic anal fissure, concomitant anorectal disease and inflammatory bowell disease will be excluded.
Intervention groups
in first group patients will undergo Closed partial lateral internal sphincterotomy؛ in the secound group patients will undergo Open partial lateral internal sphincterotomy. cure rate after surgery will be assessed and compared among groups.
Main outcome variables
wound cure rate; pain; hemorrhage; infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171023036968N1
Registration date:2018-01-13, 1396/10/23
Registration timing:registered_while_recruiting
Last update:2018-01-13, 1396/10/23
Update count:0
Registration date
2018-01-13, 1396/10/23
Registrant information
Name
sasan habib akhyari
Name of organization / entity
arak medical university
Country
Iran (Islamic Republic of)
Phone
+98 31 3345 7941
Email address
s.habibakhyari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
arak medical university
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the results and complications of chronic anal fissure surgery between open surgical sphincterotomy and closed surgical sphincterotomy
Public title
comparing the results and complications of chronic anal fissure surgery between open surgical sphincterotomy and closed surgical sphincterotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with chronic anal fissure who failed to respond to medical therapy after two weeks
Exclusion criteria:
recurrent chronic anal fissure or concomitant anal disease including anal fistula, abcess, malignancy and inflammatory bowell disease
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Not randomized
Randomization description
patients are randomi
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
Ethic's committee of Arak Medical University
Street address
Arak Medical University, basij square, Arak, Markazi province
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
IR.ARAKMU.REC.1396.107
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
wound cure rate
Timepoint
fourth and twelfth post operative days and six mounths after surgery
Method of measurement
clinical examination for assessing healing of fissure and surgical site wound
2
Description
post operative pain
Timepoint
first and fourth and twelfth post operative days
Method of measurement
screening with a 0–10 pain intensity Numeric Rating Scale
3
Description
post operative hemorrhage
Timepoint
first post operative day
Method of measurement
number of blood drenched gauzes of wound dressing during first post operative day
4
Description
post operative infection
Timepoint
first, fourth and twelfth post operative days
Method of measurement
examination for signs of cellulitis, wound discharge, induration and necrosis
Secondary outcomes
empty
Intervention groups
1
Description
first Intervention group: in this group patients will undergo closed partial lateral internal sphincterotomy. In this prosedure while nondominant index finger of surgeon is inserted in anal canal, number eleven surgical blade is inserted at dermal-anodermal junction distal to dentate line at three o'clock lithotomy position, then blade is rotated laterally and retracted with fourty five degrees lateral deviation. sufficiency of sphincterotomy and intactness of rectal mucosa is ascertained by digital examination and wound is hemostased and closed with chromic 00 sutures.
Category
Treatment - Surgery
2
Description
Secound Intervention group: in this group patients will undergo open surgery. In this procedure an incision, half to one centimeters long, is made on dermal-anodermal junction in inter sphincteric plane and internal sphincter is delivered to wound using a curved hemostat clamp and one third to one half of sphincter bulk is incised and the remainder is released to retract. sufficiency of sphincterotomy and intactness of rectal mucosa is ascertained by digital examination and wound is hemostased and closed with chromic 00 sutures.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Valiasr hospital
Full name of responsible person
Dr. Sasan Habib Akhyari
Street address
Department of General Surgery, Valiasr hospital, Valiasr square, Arak, Markazi perovince
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
s.habibakhyari@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Reza Jafari, B.Sc.
Street address
Post box 646, Alam Al Hoda st, Shiroudi st, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
s.habibakhyari@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Sasan Habib Akhyari
Position
resident of general surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
General Surgery Department, Valiasr hospital, Valiasr square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
s.habibakhyari@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak Medical University
Full name of responsible person
Dr. Sasan Habib Akhyari
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Department of General Surgery, Valiasr hospital, Valiasr square, Arak, Markazi province
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
s.habibakhyari@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak Medical University
Full name of responsible person
Dr. Sasan Habib Akhyari
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Department of General Surgery, Valiasr hospital, Valiasr square, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
Email
s.habibakhyari@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available