Determination of a functional method for decreasing the pain after hemorrhoidectomy.
Design
40 pateints undergoing open hemorrhoidectomy in the city of Birjand who reffered to Emam reza hospital were picked for this study and were divided into two group using accidental randomization. This is a single blinded clinical trial.
Settings and conduct
This is a single blinded study and is performed in the surgery ward of Imam Reza hospital in Birjand university of medical sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who underwent hemorrhoidectomy.
Exclusion criteria: Diabetes, drug abuse, other specific diseases
Intervention groups
Investigation group: In the investigation group, after open hemorrhoidectomy and complete homeostasis a gauze with 10%sucralfate ointment will be applied on the operation site and the patient will be transferred to recovery. The gauze will be placed inside the anal canal for 24 hours. After that the sucralfate ointment will be applied by the patient after each defecation and then the two variables will be measured. (1) The pain level will be measured by the VAS score 24 hours after the operation, and after that in 4-day periods until the end of epithelialization; (2) Epithelialization will be examined in 3-day periods by surgeon. Control group: In the control group, after open hemorrhoidectomy and complete homeostasis a gauze with placebo(vaseline) will be applied on the operation site and patient will be transferred to recovery.The gauze will be placed inside the canal for 24 hours. After that the placebo (vaseline) will be applied by the patient after each defecation and then the two variables will be measured as in the investigation group.
Main outcome variables
Pain and the amount of epithelialization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111211008375N17
Registration date:2018-09-23, 1397/07/01
Registration timing:retrospective
Last update:2018-09-23, 1397/07/01
Update count:0
Registration date
2018-09-23, 1397/07/01
Registrant information
Name
Seyed Amirkazem Vejdan
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3222 2300
Email address
vejdan_sa@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-10, 1396/02/20
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
2017-05-10, 1396/02/20
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
empty
Scientific title
Evaluation of the efficacy of topical sucralfate on hemorrhoidectomy wound healing process and pain severity
Public title
Evaluation of the efficacy of topical sucralfate on hemorrhoidectomy wound healing process and pain severity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who had hemorrhoidectomy surgery.
Exclusion criteria:
Diabetes
Drug abuse
Other specific diseases
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is conducted as a single blinded investigation for participants. The main reason for single blinding is the absence of another surgeon for the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Birjand University of Medical Sciences
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
Ir.bums.REC.1395.264
Health conditions studied
1
Description of health condition studied
The effect of topical sucralfate on hemorrhoidectomy wound healing process .
ICD-10 code
K64.1
ICD-10 code description
Second degree hemorrhoids
Primary outcomes
1
Description
Pain
Timepoint
The first 24 hours after operation and after that in 4-day periods until the end of epithelialization
Method of measurement
VAS
2
Description
Epithelialization
Timepoint
Every 3 days until complete epithelialization
Method of measurement
Rectal examination by surgeon
Secondary outcomes
empty
Intervention groups
1
Description
Investigation group: In the investigation group, after open hemorrhoidectomy (by Milligan-Morgan method) and complete homeostasis and ensuring of the absence of bleeding, a gauze with 10%sucralfate ointment will be applied on the operation site and the patient will be transferred to recovery. The gauze will be placed inside the anal canal for 24 hours. After that the sucralfate ointment will be applied by the patient after each defecation.
Category
Treatment - Drugs
2
Description
Control group: In this group, after open hemorrhoidectomy (by Milligan-Morgan method) and complete homeostasis and ensuring of the absence of bleeding, a gauze with placebo(vaseline) will be applied on the operation site and patient will be transferred to recovery.The gauze will be placed inside the canal for 24 hours. After that the placebo (vaseline) will be applied by the patient after each defecation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Seyyed AmirKazem Vejdan
Street address
Taleghani street
City
birjand
Province
South Khorasan
Postal code
9714811151
Phone
+98 56 3222 2300
Email
vejdan_sa@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tuba Kazemy
Street address
Ghaffari Street , Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 0388
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr Amir kazem vejdan
Position
Specialist in general surgery, Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Reza hospital
City
Birjand
Province
South Khorasan
Postal code
9714811151
Phone
+98 56 3222 2300
Email
vejdan_sa@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Amir Kazem Vejdan
Position
Specialist in general surgery, Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Taleghani St
City
Birjand
Province
South Khorasan
Postal code
9714811151
Phone
+98 56 3222 2300
Email
vejdan_sa@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
maryam daneshmand
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No.31, saa'di 3 St, Moallem Blvd
City
Birjand
Province
South Khorasan
Postal code
9714811151
Phone
+98 56 3243 3872
Email
maryamd669@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The shared data will include a patient-specific file for both control and intervention groups, including age and gender, and the patients responses in each step of the study to any intervention. This includes only parts of the entire data.
When the data will become available and for how long
Data access starts in 1398 (2020) and ends in 1400 (2022).
To whom data/document is available
The data can be sent to all students and researchers affiliated to medical universities of Iran.
Under which criteria data/document could be used
The applicants must provide the general information about their place of employment or university, the student number and the reason for requesting this information in their request e-mail. Obviously, if they have the data, they can perform tests in order to verify the accuracy of the statistical analysis.
but any other use Without the permission of the researcher of this study is not allowed.
From where data/document is obtainable
Applicants can send their requests to Doctor Vejdan by this e-mail address : vejdan_sa@bums.ac.ir
What processes are involved for a request to access data/document
Any eligible applicant must send an e-mail to: vejdan_sa@bums.ac.ir
including a notice containing their academic and university information and the purpose of the data request, and then after a maximum of 4 weeks,the data file will be received the from the above e-mail address.