Our aim is to introduce a new technique named Jump to help further the surgeons in the management of anal fistulae and to reduce further the complications. In this study every patient with anal fistula of cryptoglandular origin from 20 to 70 years included, and patient with anal fistula due to trauma, Inflammatory bowel disease, Irradiation, pilonidal sinus and cases with previous anal incontinence were excluded.Every patient with anal discharge who refered to the surgical clinic of Shohade-e-Tajrish Medical Center were considered as our understudy population.Our cases includs patients with chronic anal discharge which after excluding the patients with non cryptoglandular origin should include fifty patients to reach the optimum number of this study.In this technique at first step, external os and tract was dissected by cautery and followed to reach the rectal wall.At second step, an incision was made at anal verge and subanodermal pocket was created and followed up to internal os.This two tunnel interconnected to each other by puncturing the rectal wall. At third step the tract was delivered from existing site to subanodermal position and fixed there.Our sampling will go on up to 2015/01/01 .Pilot study showed no any adverse effect.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012720831N1
Registration date:2015-02-20, 1393/12/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-20, 1393/12/01
Registrant information
Name
Jalaluddin Khoshnevis
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2274 9214
Email address
khoshnevis.j@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Mr Afshin Zarghie ,Shahid Beheshti University of Medical Sciences (SBMU) ,Deputy of Research
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2015-01-01, 1393/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Jump Technique, a new innovation for treatment of the anal fistula and its outcome in simple and complex group
Public title
A new technique (JUMP ) in surgery of anal fistula
Purpose
Treatment
Inclusion/Exclusion criteria
All patients with cryptoglandular fistula aged 20 to 70 years were enrolled and in the case of anal fistula due to trauma, inflammatory bowel disease, radiation, or Pilonidal sinus or Pilonidal Sinus with previous incontinence were excluded .
Inclusion criteria:Cryptoglandular fistula; Age from 20 to 70 years old
Exclusion criteria:Anal fistula due to trauma; Inflammatory bowel disease; Irradiation; Pilonidal sinus;and cases with previous anal incontinence
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Anal pain and contour were also studied.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Postal code
1985717443
Approval date
2013-01-05, 1391/10/16
Ethics committee reference number
129th Ethical Committee
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
Minor and major fecal incontinence
Timepoint
Weekly for one month, monthly for one year, every three month for three years
Method of measurement
By the table of FISI if incontenance is present
Secondary outcomes
1
Description
Anal pain
Timepoint
Day 1,2,3 after operation
Method of measurement
By VAS
2
Description
Anal discharge
Timepoint
monthly up to three years
Method of measurement
Physical examination
Intervention groups
1
Description
A clinical trial in which the outcome of JUMP technique for the treatment of anal fistula was evaluated. In this technique the fistula tract is trans located to subanodermal position whithout sphicter muscle cutting.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shoha-e- Tajrish Medical Center
Full name of responsible person
Jalaluddin Khoshnevis
Street address
Tajrish Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tavirani Rezaei Mostafa
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jalaluddin Khoshnevis
Position
Associate Professor of Surgery
Other areas of specialty/work
Street address
Tajrish Square
City
Tehran
Postal code
1989934148
Phone
+98 21227180009
Fax
+98 21 2274 9214
Email
khoshnevis.j@sbmu.ac.ir
Web page address
www.sbmu.ac.ir/sitedirectory/shohadatajrish
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jalaluddin Khoshnevis
Position
Associate Professor of Surgery
Other areas of specialty/work
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
Email
info@sbmu.ac.ir
Web page address
www.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jalaluddin Khoshnevis
Position
Associate Professor of Surgery
Other areas of specialty/work
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)