Comparison of results of colostomy closure by purse-string and linear methods in children
Design
Clinical trial with intervention and control groups,100 patients sample size, Trial phase 2-3.Simple randomization based on random numbers table.
Settings and conduct
100 patients with intestinal colostomy who met inclusion criteria among candidates referred to Imam Khomeini and Golestan hospitals in 2017-2019 were divided to control or intervention groups. In intervention group, the skin was closed by purse-string method include an incision around the ileostomy. In control group, the skin was closed to the ileum by an elliptical incision around the colostoma.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ages 0-6 years ; Reversible loop ileostomy ; Elective closure of colostomy ; Parent consent for their child participation in the project
Exclusion criteria: Death; Patient failure to cooperate during follow-up; The existence of a new stoma at the time of study; Speech problems and mental disorders.
Intervention groups
Intervention group: In this group the skin was closed by purse-string method include an incision around the ileostomy that was similar to the linear method. But the cut was roughly split using a sub-cuticle rope (2-0 Polysorb).
Control group: In this group, closure of the skin was done by an elliptical incision around the colostoma to the ileum, fascia then the skin was sutured.
Main outcome variables
Duration of wound healing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121010011068N3
Registration date:2019-12-07, 1398/09/16
Registration timing:registered_while_recruiting
Last update:2019-12-07, 1398/09/16
Update count:0
Registration date
2019-12-07, 1398/09/16
Registrant information
Name
Shahnam Askarpour
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 0656
Email address
shahnam_askarpour@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-31, 1398/08/09
Expected recruitment end date
2019-12-20, 1398/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the results of colostomy closure with purse-string and linear methods in pediatric patients
Public title
Comparative treatment results of colostomy closure with purse-string and linear methods in pediatric patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 0-6 years
Reversible loop ileostomy
Candidate for elective closure of ileostomy
Parents' consent
Exclusion criteria:
Age more than 6 years
Death
Patient failure to cooperate during follow-up
The existence of a new stoma at the time of study
Speech problems and mental disorders
Age
To 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization based on random numbers table, in this method, we set a set of numbers without a specific pattern and order, and completely randomly in the table. We consider the even numbers as intervention group and the odd numbers as control group. Then accidentally put the finger on one of the numbers in table and then move upwards, register the number and assign one to an intervention or control group.
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences, University City
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-04-30, 1398/02/10
Ethics committee reference number
IR.AJUMS.REC.1398.009
Health conditions studied
1
Description of health condition studied
Closestomy closure
ICD-10 code
Z43.3
ICD-10 code description
Encounter for attention to colostomy
Primary outcomes
1
Description
Duration of wound healing
Timepoint
postoperativedays 1, 2 and 3, at the hospital discharge, and 30 days, 6 and 12 months after surgery.
Method of measurement
Observation and examination by a physician
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group the skin is closed by purse-string method includes an incision around the ileostomy that is similar to the linear method. But the cut is roughly split using a sub-cuticle rope (2-0 Polysorb).
Category
Treatment - Surgery
2
Description
Control group: In this group, skin closure involves an elliptical incision around the Colostoma to the ileum and fascia is sutured then the skin is sutured with artificial suture.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital
Full name of responsible person
Shahnam Askarpour MD.
Street address
Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2922
Fax
Email
shahnam_askarpour@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badvi P.H.D
Street address
Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences, University City
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
vchresearch@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahnam Askarpour MD.
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2922
Email
shahnam_askarpour@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahnam Askarpour MD.
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2922
Email
shahnam_askarpour@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahnam Askarpour MD.
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Azadegan St.
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3222 2922
Email
shahnam_askarpour@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The whole data can be shared after unidentifiable people.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Only available to scholars working in academic and academic institutions
Under which criteria data/document could be used
Employed in research centers
From where data/document is obtainable
Person responsible for scientific inquiries
What processes are involved for a request to access data/document
Send email to person responsible for scientific inquiries