Evaluation of the results of using the ERAS protocol in the process of recovery of children in need of colostomy
Design
This study is a non-blinded, randomized clinical trial with a parallel design. This randomized study will be conducted on 86 children who are eligible for surgery. A random block is used for randomization and the participants are assigned to two intervention groups.
Settings and conduct
This study will be conducted in Imam Hossein Hospital in Isfahan city. Patients in both groups are fasting from 12:00 PM the night before the operationو and no painkillers are prescribed before the operation. In both groups, the type and method of surgery are the same and the same surgeon performs it. Therefore, the surgery should be performed for both groups, encouraging spirometry and respiratory physiotherapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 1 day and 15 years; Patients who are candidates for colostomy surgery; Consent of patients or their parents
Exclusion criteria: Underlying disease that leads to tissue repair impairments (such as sever malnutrition or connective tissue disease
Intervention groups
In the first intervention group (traditional protocol), the patient remains fasting for 5 days after the operation, and we prescribe albumin, vitamins and carbohydrates (dextrose serum) for the patient, and put him under intravenous nutrition, and the diet does not start earlier than 5 days. In the second intervention group (ERAS), usually 24 to 48 hours after the operation, depending on when the patient defecates, we start the liquid diet for the patient and do not put the patients under intravenous nutrition.
Evaluation of the results of using the ERAS protocol in the process of recovery of children in need ofcolostomy reversal referred to Isfahan
Public title
Evaluation of the results of using the ERAS protocol in the process of recovery of children in need ofcolostomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 1 day and 15 years
Patients who are candidates for colostomy surgery
Consent of patients or their parents
Exclusion criteria:
Underlying disease that leads to tissue repair impairments (such as sever malnutrition or connective tissue disease)
Age
From 1 day old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code.
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2023-02-21, 1401/12/02
Ethics committee reference number
IR.MUI.MED.REC.1401.407
Health conditions studied
1
Description of health condition studied
Colostomy
ICD-10 code
K94.00
ICD-10 code description
Colostomy complication, unspecified
Primary outcomes
1
Description
wound infection
Timepoint
One week, 1 month and 2 months after the operation
Method of measurement
doctor's examination
2
Description
Re-hospitalization
Timepoint
One week, 1 month and 2 months after the operation
Method of measurement
Asking the patient
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group (traditional protocol), the patient remains fasting for 5 days after the operation, and we prescribe albumin, vitamins and carbohydrates (dextrose serum) for the patient, and put him under intravenous nutrition, and the diet does not start earlier than 5 days.
Category
Treatment - Drugs
2
Description
In the second intervention group (ERAS), usually 24 to 48 hours after the operation, depending on when the patient defecates, we start the liquid diet for the patient and do not put the patients under intravenous nutrition.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr. Mehrdad Hosseinpour
Street address
km 10, Imam Khomeini Street
City
Isfafan
Province
Isfehan
Postal code
8474673461
Phone
+98 31 3386 6266
Email
meh_hosseinpour@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3668 5149
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Hosseinpour
Position
Member of the university faculty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric surgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
Meh_hosseinpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Hosseinpour
Position
Member of the university faculty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric surgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Email
meh_hosseinpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Hosseinpour
Position
Member of the university faculty
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric surgery
Street address
Isfahan University of Medical Sciences, Hezar Jarib St..
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3071
Fax
Email
Meh_hosseinpour@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD