Objective: Evaluation the effect of internal sphincterotomy on wound healing rate and the pain after open hemorrhoidectomy surgery in Semnan Kowsar hospital
Study design: single blinded randomized clinical trial study, without placebo control
population: Patients with grade III and IV hemorrhoid referred to Kowsar hospital in order to surgery and they only need to remove a hemorrhoid gland
Inclusion criteria: Patients aged 20-70 years with grade III and IV hemorrhoid referred to Kowsar hospital in order to surgery and they only need to remove a hemorrhoid gland
Exclusion criteria: history of previous anal surgery; patients with Anal Fissure; patients with Anal Fistula; patients with Anal Abscess; incarcerated hemorrhoid and or thrombosis; pregnancy; patients who need to few hemorrhoids lump surgery; patients with other Anal abnormalities; taking anticoagulants and antiplatelet drugs; history of inflammatory bowel disease (IBD); addicted patients
Sample size, intervention, intervention time and outcome of study: Sample size of this study is 40 persons will be divided into intervention and control groups.
Intervention group: Intervention group included patients who are undergoing to open hemorrhoidectomy surgery with internal sphincterotomy. All surgeries are performed under general anesthesia and open surgery. Also in all cases hemorrhoids vascular basement are closed with chromium yarn 0.2.
Control group: Control group include just patients who are undergoing to open hemorrhoidectomy surgery and just the results is used to compare with experimental group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017081325732N25
Registration date:2017-10-15, 1396/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-15, 1396/07/23
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of internal sphincterotomy in wound healingrate and post operative pain after open hemorrhoidectomy
Public title
Evaluation of the Effect of internal sphincterotomy in wound healingrate and post operative pain after open hemorrhoidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 20-70 years with grade III and IV hemorrhoid referred to Kowsar hospital in order to surgery and they only need to remove a hemorrhoid lump.
Exclusion criteria: History of previous anal surgery; patients with Anal Fissure; patients with Anal Fistula; patients with Anal Abscess; incarcerated hemorrhoid and or thrombosis; pregnancy; patients who need to few hemorrhoids lump surgery; patients with other Anal abnormalities; taking anticoagulants and antiplatelet drugs; history of inflammatory bowel disease (IBD); addicted patients.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
semnan
Postal code
3514799442
Approval date
2017-07-12, 1396/04/21
Ethics committee reference number
IR.SEMUMS.REC.1396.102
Health conditions studied
1
Description of health condition studied
Hemorrhoidectomy
ICD-10 code
I84.2
ICD-10 code description
Internal haemorrhoids without complication
Primary outcomes
1
Description
Postoperative pain
Timepoint
12 hours after surgery and once at the time discharge
Method of measurement
Questionnaire (based on Visual Analog Scale)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Control group include just patients who are undergoing to open hemorrhoidectomy surgery.
Category
Diagnosis
2
Description
Intervention group: Intervention group included patients who are undergoing to open hemorrhoidectomy surgery with internal sphincterotomy. All surgeries are performed under general anesthesia and open surgery. Also in all cases hemorrhoids vascular basement are closed with chromium yarn 0.2.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Setareh Soltany
Street address
Amin Blvd, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology, Semnan University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Asgari
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology, Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Setareh Soltany
Position
General surgeon
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
SetarehSoltany@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Setareh Soltany
Position
General surgeon
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+233 3451336
Fax
Email
setarehsoltany@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Setareh Soltany
Position
General surgeon
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8950
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)