The objective of this study is to evaluate the effect of internal sphincterotomy on the pain after open hemorrhoidectomy. Inclusion criteria are patients with third and fourth degree hemorrhoid and exclusion criteria are having anal fisher with hemorrhoid. Population of this study was 60 patients with third and fourth degree hemorrhoid, who had referred to Shaheed Rajaee hospital in 2007-2008. The intervention of this study was internal sphincterotomy. Primary outcome of this study was pain after open hemorrhoidectomy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903214149N1
Registration date:2010-08-26, 1389/06/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-08-26, 1389/06/04
Registrant information
Name
Majid Pouya
Name of organization / entity
Faculty of Medicine, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 19 2422 1095
Email address
m.pouya@tonekaboniau.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University, Tonekabon Branch
Expected recruitment start date
2007-06-22, 1386/04/01
Expected recruitment end date
2008-06-21, 1387/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Lateral internal sphincterotomy in post hemorrhoidectomy pain
Public title
The effect of Lateral internal sphincterotomy in post hemorrhoidectomy pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hemorrhoid grade 3 & 4
Exclusion criteria: presence of fisher or other anorectal pathology
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine, Islamic Azad University, Tonekabon Branch
Street address
Vali Abad, Islamic Azad University, Tonekabon Branch
City
Tonekabon
Postal code
Approval date
empty
Ethics committee reference number
03-15-5/7331
Health conditions studied
1
Description of health condition studied
hemorrhoid
ICD-10 code
K62
ICD-10 code description
Other diseases of anus and rectum
Primary outcomes
1
Description
post hemorrhoidectomy pain
Timepoint
1, 2, 3, 4, 5, 6 days after intervention
Method of measurement
visual analogs scale
Secondary outcomes
1
Description
bleeding after defeacation
Timepoint
1, 2, 3, 4, 5, 6, 7 days after intervention
Method of measurement
questionnaire
2
Description
urinary retention
Timepoint
1, 2, 3, 4, 5, 6 days after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Open internal sphincterotomy
Category
Treatment - Surgery
2
Description
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaee Hospital
Full name of responsible person
Dr Samane Abedidost
Street address
Department of Surgery, Islamic Azad University, Tonekabon Branch
City
Tonekabon
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Tonekabon Branch
Full name of responsible person
Dr Samane Abedidost
Street address
Department of Surgery, Islamic Azad University, Tonekabon Branch
City
Tonekabon
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Tonekabon Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University, Tonekabon Branch
Full name of responsible person
Dr Samane Abedidost
Position
GP
Other areas of specialty/work
Street address
Department of Surgery, Islamic Azad University, Tonekabon Branch
City
Tonekabon
Postal code
Phone
+98 19 2422 1095
Fax
Email
s_a_422@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Surgery, Islamic Azad University, Tonekabon Branch
Full name of responsible person
Dr Samane Abedidost
Position
GP
Other areas of specialty/work
Street address
Department of Surgery, Islamic Azad University, Tonekabon Branch
City
Tonekabon
Postal code
Phone
+98 19 2422 1095
Fax
Email
s_a_422@yahoo.comshafe448@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Tonekabon Branch
Full name of responsible person
Dr Mohamad Shafe Shakouri
Position
GP
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
shafe448@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)