Anal fistula including common and debilitating disease that is characterized by severe pain and discharge. For many years, the treatment of choice for this disease remains to be Fystulectomy, while this approach in cases of complex fistulas and high fistulas leads to incontinence and potentially damaging consequences. Alternative therapies in the treatment of fistulas have also had little success. The aim of this study was to evaluate the results of fystulectomy with closing the internal opening and sphincter repair as a novel treatment is the cases of complex fistulas.
This study is a prospective study which was conducted in Besat educational & medical center of Hamadan medical university. All patients with complex anal fistulas from October 2006 to October 2011 were entered the study and underwent fystulectumy surgery with closure of internel opening.Low rate of incontinence was measured with a standard wexner scale. Early complications after surgery were investigated before discharge and one week after surgery. The incidence of incontinence and recurrence after 3 and 6 months of follow-up period, were evaluated.Wexner quantitative measure of incontinence was evaluated using a standard Wexner scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122011591N1
Registration date:2013-04-14, 1392/01/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-04-14, 1392/01/25
Registrant information
Name
Hamid Esmailpoor
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1821 4072
Email address
h.esmailpoor@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Sponsored by research deputy of Hamedan University of Medical Science.
Expected recruitment start date
2012-06-04, 1391/03/15
Expected recruitment end date
2012-12-05, 1391/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of fistulectomy method and ligation of internal orifice in treatment of complex perianal fistula as a new method.
Public title
New Fistulectomy method in treatment of patients with complex perianal fistula.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Anal fistula : high anal fistula; complex anal fistula.
Exclusion:Anal fistula : low anal fistula; history of incontinance; Perevious sphingter injery.
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Science
Street address
Shahid Fahmide St.
City
Hamedan
Postal code
65178
Approval date
2012-04-22, 1391/02/03
Ethics committee reference number
245/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Anal fistula
ICD-10 code
K60.3
ICD-10 code description
Anal fistula
Primary outcomes
1
Description
Recurrance of desease
Timepoint
in 3 and 6 mons follow up period
Method of measurement
Physical examination
2
Description
Incontinance
Timepoint
after sugery and 3 & 6 mons later
Method of measurement
Jorge-Wexner scale
Secondary outcomes
1
Description
Complications
Timepoint
After surgery and 3 & 6 mons later
Method of measurement
Physical examination
Intervention groups
1
Description
Fistulectomy method and ligation of internal orifice
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Beasat Hospital, Booali hospital of Hamedan
Full name of responsible person
Street address
Beasat hospital, Resaalat sq.
City
Hamedan
2
Recruitment center
Name of recruitment center
Besat Hos.
Full name of responsible person
Hamid Esmailpoor
Street address
Surgery Departman Besat Hos.
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Hamedan University of Medical Science
Full name of responsible person
Mrs Azimi
Street address
Central site of Hamedan university of medical science
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Hamedan University of Medical Science
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
Hamedan University of Medical Science
Full name of responsible person
Hamid Esmailpoor
Position
Surgery resident
Other areas of specialty/work
Street address
Beasat hospital Resaalat Sq.
City
Hamedan
Postal code
Phone
+98 914 182 1590
Fax
Email
H.esmailpoor@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Hamid Esmailpoor
Position
Surgery resident
Other areas of specialty/work
Street address
Resaalat Sq, Beasat hospital.
City
Hamedan
Postal code
Phone
+98 81 1264 0048
Fax
Email
H.esmailpoor@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Nazila Hasanzadeh Ghavifekr
Position
surgery resident
Other areas of specialty/work
Street address
Resaalat Sq, Beasat hospital.
City
Hamedan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)