A comparative study of complications in single stage with triple stage conventional repair of imperforated anus disease in female neonates in Kermanshah
This study is a blind, randomized clinical trial. The purpose of this study is comparison between complications of two methods of surgery (single stage and conventional triple stage) in repair of imperforated anus with rectovestibular fistula in female infants who are candidates for surgical repair in Imam Reza hospital of Kermanshah. The patients with acute obstruction are excluded from this study. A total of 60 patients are randomly allocated to two groups of intervention. In first group (single stage surgery) patients after primary preparations will undergo Posterior Sagittal Anorectoplasty procedure. In second group (conventional triple stage surgery) at first stage, patients will undergo colostomy fitting procedure and then at second stage, a Posterior sagittal Anorectoplasty will be done and at third stage, the fitted colostomy will be closed. Both groups will be followed at first week, first month, third month and sixth month after surgery and complications (wound infection, anus stenosis and vaginal trauma) will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204239547N1
Registration date:2012-10-23, 1391/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-10-23, 1391/08/02
Registrant information
Name
Saman Ketabchian
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6312
Email address
dr.s.ketabchian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Science
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of complications in single stage with triple stage conventional repair of imperforated anus disease in female neonates in Kermanshah
Public title
Study of single stage with triple stage conventional repair of imperforated anus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all female children under one year old with diagnosis of imperforated anus and rectovestibular fistula.
Exclusion criteria: urgent circumstances such as acute obstruction and dissatisfaction of parents with single stage procedure.
Age
To 1 year old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will divided randomly (an in-between) into two intervention groups equally without awareness of surgeon.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah
City
Kermanshah
Postal code
Approval date
2012-04-17, 1391/01/29
Ethics committee reference number
پ/7/420/1364
Health conditions studied
1
Description of health condition studied
Imperforated anus
ICD-10 code
Q42.2
ICD-10 code description
Congenital absence, atresia and stenosis of anus with fistula
Primary outcomes
1
Description
Wound infection
Timepoint
A week after procedure
Method of measurement
Surgeon diagnosis
2
Description
Anus stenosis
Timepoint
One and three and six months after surgery
Method of measurement
Surgeon diagnosis
3
Description
Vaginal trauma
Timepoint
During procedure
Method of measurement
Surgeon diagnosis
Secondary outcomes
empty
Intervention groups
1
Description
In single stage group without fitting a colostomy, only a Posterior Sagittal Anorectoplasty (repair of fistula and reconstruction of anus) is done.
Category
Treatment - Surgery
2
Description
In triple stage group the intervention is fitting an end sigmoid colostomy with laparatomy at first stage and then at second stage Posterior Sagittal Anorectoplasty (repair of fistula and reconstruction of anus) is done and at third stage, the fitted colostomy will be closed after two months with laparatomy.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital of Kermanshah
Full name of responsible person
Saman Ketabchian
Street address
Imam Reza hospital, Parastar Blvd., Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshti Blvd., Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Saman Ketabchian
Position
Resident of general surgery
Other areas of specialty/work
Street address
General surgery ward, Imam Reza hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6311
Fax
+98 83 1427 6343
Email
dr.s.ketabchian@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Omid Amanollahi
Position
Pediatric surgeon
Other areas of specialty/work
Street address
General surgery ward, Imam Reza hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1427 6312
Fax
+98 83 1427 6343
Email
Oamanolahi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Keramanshah University of Medical Sciences
Full name of responsible person
Saman Ketabchian
Position
Resident of general surgery
Other areas of specialty/work
Street address
General surgery ward, Imam Reza hospital, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1838 7437
Fax
Email
Dr.s.ketabchian@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)