Introduction and aim: Due to economic problem, sigmoid loop colostomy using glass rod may cause problems for our patients for finding glass rod and several visits. So we decided to compare rod versus skin bridge colostomy.
Design: case-control
Inclusion criteria: all children who are candidate for colostomy were included.
Procedures: Patients underwent skin bridge or rod colostomy
Outcome measures: Infection, retraction, and prolapse of colostomy were compared.
General information
Acronym
colostomy
IRCT registration information
IRCT registration number:IRCT201111098037N1
Registration date:2012-12-23, 1391/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-23, 1391/10/03
Registrant information
Name
Shahnam Askarpour
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1221 6501
Email address
shahnam_askarpour@yahoo.com
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2011-03-28, 1390/01/08
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Skin bridge versus rod colostomy in children: comparison of complication
Public title
Comparison of complication of colostomy with two methods in children
Purpose
Treatment
Inclusion/Exclusion criteria
All children cases who are candidate for colostomy were included in this study
Age
To 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz
City
Ahvaz
Postal code
Approval date
2010-10-29, 1389/08/07
Ethics committee reference number
ETH-257
Health conditions studied
1
Description of health condition studied
Colostomy
ICD-10 code
K91.04
ICD-10 code description
Colostomy and enterostomy malfunction
Primary outcomes
1
Description
prolapse
Timepoint
30 days
Method of measurement
Observation
2
Description
retraction
Timepoint
30 days
Method of measurement
observation
3
Description
infection
Timepoint
30 days
Method of measurement
observation
Secondary outcomes
1
Description
ِduration of surgery
Timepoint
during operation
Method of measurement
chronometer
Intervention groups
1
Description
Colostomy with skin brdge versus rod glass
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical sciences
Full name of responsible person
Shahnam Askarpour
Position
Associate Professor
Other areas of specialty/work
Street address
Dept. of Surgery, Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1221 6504
Fax
Email
shahnam_askarpour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahnam Askarpour
Position
Associate Professor
Other areas of specialty/work
Street address
Dept. of Surgery, Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
+98 61 1221 6504
Fax
Email
shahnam_askarpour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahnam Askarpour
Position
Associate Prof. of Surgery
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Ahvaz
Postal code
Phone
00
Fax
Email
shahnam_askarpour@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)