Comparison of the side effects and safety of hemorrhoidectomy with Ligasure compared to conventional hemorrhoidectomy
Design
Clinical trial with control group, with parallel group; Double blind, randomized
Settings and conduct
This study is being performed at Imam Reza Hospital in Birjand, South Khorasan Province. 54 patients are randomly divided into two groups: Ligasure surgery and Ferguson method. Then the amount of pain in patients in two groups in the hours of 24, 12, 6 and 0 after surgery, postoperative complications in patients including: urinary retention, the amount of postoperative bleeding, The duration of hospitalization in the ward will be incontinence and defecation, nausea and vomiting, which will be examined by the nurse without surgery and one day after the operation without the patient's knowledge of the type of surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Lack of Disease of liver, kidney, bronchial asthma, gestational hypertension, preeclampsia, and coagulation disorders
Intervention groups
Patients who are candidates for hemorrhoid surgery are divided into two groups: Ferguson with 27 patients or the Ligasure group with 27 patients.
Main outcome variables
the pain
Complications after surgery
Bleeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190618043934N3
Registration date:2020-05-04, 1399/02/15
Registration timing:registered_while_recruiting
Last update:2020-05-04, 1399/02/15
Update count:0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of complications, and safety of ligamentous hemorrhoidectomy in comparison with conventional hemorrhoidectomy
Public title
Comparison of the effects of hemorrhoidectomy with Ligasure method with Ferguson method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of Disease of liver
Lack of Disease kidney
Lack of Disease of bronchial asthma
Lack of Disease of gestational hypertension
Lack of Disease of preeclampsia
Lack of Disease of coagulation disorders
Exclusion criteria:
Dissatisfaction with participating in the study
concurrent hemorrhoids with other pre-anal problems
any other unpredictable event for patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
27
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking method of Simple random sampling
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in the study
interferer
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Moallem BLV
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2020-01-27, 1398/11/07
Ethics committee reference number
Ir.bums.REC.1398.336
Health conditions studied
1
Description of health condition studied
Hemorrhoid Disease
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis
Primary outcomes
1
Description
Pain
Timepoint
0, 6, 12 and 24 hours after surgery
Method of measurement
Using the VAS ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Ligasure surgery is performed by general surgery.
Category
Treatment - Surgery
2
Description
Intervention group 2: Ferguson surgery is performed by general surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital_Birjand
Full name of responsible person
Mohammad Yaser Dadpour Rodi
Street address
Moallem Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Ghaffari Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3238 1200
Email
oabstudent@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
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Moallaem St
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohsen Najmaddini
Position
Member of the Faculty
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Taleghani Str
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Moallem St
City
Birjand
Province
South Khorasan
Postal code
9717811674
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no need to publish individual patient information
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