comparison between two methods of hemorrhoidectomy including Miligan-Morgan and Ferguson in patient with hemorrhoeid degree 3 or 4
Design
randomized;clinical trial with two parallel groups design of 60 pateits
Settings and conduct
After selecting sixty patients with hemorrhoids, patients who are referred to the clinic of Razi Hospital and confirmed the necessity for surgery, are randomly divided into two groups of thirty patients, one of the groups will be undergoing the Ferguson hemorrhoidectomy and the other group will be undergoing Milligan-Morgan hemorrhoidectomy.These patients will be monitored for one month to check the outcomes and possible post-operative complication and they will be examined at least once
Participants/Inclusion and exclusion criteria
inclusions criteria: pateint’s age berween 18 to 60; pateints with internal hemorrhoid(third or fourth grade) or complex hemorrhoid;
exclusion criteria: thrombosed hemorrhoid; addiction; history of anorectal surgery; anal fissure or fistula
Intervention groups
including two groups that one them operate by Miligan-Morgan method and the other one operates by Ferguson method
Main outcome variables
pain in first,second and third day after surgery, length of stay in the hospital, amount of bleeding, infection, time to back to work
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180516039681N1
Registration date:2018-10-26, 1397/08/04
Registration timing:registered_while_recruiting
Last update:2018-10-26, 1397/08/04
Update count:0
Registration date
2018-10-26, 1397/08/04
Registrant information
Name
Soroosh Aghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3732 5872
Email address
sorooshaghaee@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain after surgury between two methods of hemorrhoidectomy Miligan-Morgan and Ferguson in patients with grade 3 and 4 hemorrhoid
Public title
Comparison between open and closed hemorrhoidectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Internal heamorrhoid grade 3 or 4
Internal heamorrhoid or coplex
Age between 18 to 60
Exclusion criteria:
History of previous anorectal surgery
Thrombosed hemorrhoid
Addictoin
Anal fissture or fistula
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done by random number table
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
ethic committee of ahvaz university of medical sciences
Street address
ahvaz jundishapur university of medical sciences;golestan blvd
City
ahvaz
Province
Khouzestan
Postal code
6137515794
Approval date
2017-12-24, 1396/10/03
Ethics committee reference number
IR.AJUMS.REC.1397.105
Health conditions studied
1
Description of health condition studied
methods of hemorrhoidectomy
ICD-10 code
K64.9
ICD-10 code description
Unspecified hemorrhoids
Primary outcomes
1
Description
pain
Timepoint
pain in first,second and third day after surgery
Method of measurement
visual analog scale
2
Description
length of stay in the hospital
Timepoint
after the surgery
Method of measurement
counting length of stay
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: undergoing Ferguson hemorrhoidectomy, in which the skin and mucus are completely closed by suturing.
Category
Treatment - Surgery
2
Description
Intervention group: Undergoing Miligan-Morgan hemorrhoidectomy in which skin ulcer is left open
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
razi hospital
Full name of responsible person
neda najibpour
Street address
razi hospital,felestin st,amanie ave,
City
ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 5935
Email
nnajibpour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mohammad badavi
Street address
Ahvaz jundishapur medical science, Golestan Blvd,
City
Ahvaz
Province
Khouzestan
Postal code
6137515794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
neda najibpour
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
razi hospital,felestin st,amanie ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 5935
Email
nnajibpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
neda najibpour
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
razi hospital,felestin st,amanie ave
City
Ahvaz
Province
Khouzestan
Postal code
6196514941
Phone
+98 61 3333 5935
Email
nnajibpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Soroosh Aghaei
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 3, East kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6155934559
Phone
+98 71 3732 5872
Fax
Email
Sorooshaghaee@yahoo.com
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