The aim of this randomized clinical trial is to compare between two surgical methods for heamorrhoidectomy those are named Milligan -morgan (Open=group A) and Fergusen (Close=group B) regrding postoperative sign , symptoms and long term result in Imam Khomeini hospital of Sari, Iran. A total of 100 patients with three or four degree heamorrhoid heamorrhoidectomy and meeting eligibilty criteria are randomly allocated into two groups. In 50 patients milligan -morgan(open) method is used; in this method after resection the heamorrhoid and ligation the pedicle wounds are not closed and in other 50 patient Fergusen (close ) method is used; in this method after heamorrhoidectomy wounds are closed. Details of operations, post operative complications and length of postoperative stay are recorded. Pain is assessed from a Visual Analogue Scale and by registration of postoperative analgesic medication. Fallow -up is done at hours 6 and 24 and days 14 and 28. Wound healing duration, postoperative bleeding, wound hematoma, abscess, fistula formation and anal stricture are followed by visits or telephone interview by surgeon once a week for one month and once a month for six months and result are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202041786N2
Registration date:2012-02-27, 1390/12/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-27, 1390/12/08
Registrant information
Name
Nasrin Rahmani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 1700
Email address
nrahmani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparsionof open heamorrhoidectomy vs closed in pationts admitted in Imam Khomeini hospital, Sari, Iran 2008-2009
Public title
Comparsion between two surgical method for heamorrhoid treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: all patient with third and forth degree heamorrhoid suitable for heamorrhoidectomy
Exclusion criteria: patients with other anorectal disease like fissure or fisstula; patients who have contrandication for anesthesia; every patient with wound healing problem and high risk for infection like diabetes mellitus.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran univercity of medical sciences
Street address
Moallem square,Biulding NO 2
City
Sari
Postal code
Approval date
2010-09-08, 1389/06/17
Ethics committee reference number
89-67
Health conditions studied
1
Description of health condition studied
heamorrhoid
ICD-10 code
I84.8,I84.
ICD-10 code description
heamorrhoids with complication_heamorrhoids without complication
Primary outcomes
1
Description
Pain severity
Timepoint
Hours 6 and 24 and days 14 and 28 postoperative
Method of measurement
Visual Analogus Scale
2
Description
Bleeding and heamatom
Timepoint
Every week for one month and every month for 6 month
Method of measurement
Physical examination
3
Description
Post operative hospital stay
Timepoint
Hospital stay
Method of measurement
Medical file
4
Description
Duration of operation
Timepoint
Record in the operative room at the time of operation
Method of measurement
Medical file
Secondary outcomes
1
Description
Abcces and fistul formation
Timepoint
Every week for one month and every month for 6 months
Method of measurement
Vsit or telephone interview
2
Description
Anal stricture
Timepoint
Month sixth
Method of measurement
visit
Intervention groups
1
Description
Closing the wound after resection the heamorrhoids and ligation the vascular pedicle (Ferguson mthod)
Category
Treatment - Surgery
2
Description
Wounds are not closed after heamorrhoid resection and ligator of pedicle(Milligan-Morgan)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini general Hospital
Full name of responsible person
Dr Nasrin Rahmani Boeeni
Street address
Amir Mazandarani Bulvar,Emam Khomaini Hospital
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran Univercity of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Moallem Square-Bulding NO 2
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran Univercity 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
Surgery ward- Imam Khomeini Hospital
Full name of responsible person
Dr Nasrin Rahmani Boeeni
Position
Assistant Professor
Other areas of specialty/work
Street address
Amia Mazandarani Bulv.
City
Sari
Postal code
Phone
+98 15 1226 3537
Fax
Email
nrahmani@mazums.ac.ir; drrahmani124@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran Univercity of Medical SCienes
Full name of responsible person
Dr Nasrin Rahmani Boeeni
Position
Assistant Professor, General Surgeon
Other areas of specialty/work
Street address
Amir mazandarani Bulvar,Emam Khomeini Hspital
City
Sari
Postal code
Phone
+98 15 1226 3537
Fax
Email
nrahmani@mazums.ac.ir; drrahmani124@gmail
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Dr Nasrin Rahmani Boeeni
Position
Assistant Professor
Other areas of specialty/work
Street address
Amir Mazandarani Bulvar, Imam Khomeini hospital
City
Sari
Postal code
Phone
+98 15 1226 3537
Fax
Email
nrahmani@mazums.ac.ir; drrahmani124@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)