Clinical trial of comparison of effectiveness of proximal to anastomosis T-tube enterostomy versus conventional end to end anastomosis in treatment of neonates with intestinal atresia
Clinical trial of comparison of effectiveness of proximal to anastomosis T-tube enterostomy versus conventional end to end anastomosis in treatment of neonates with intestinal atresia
Design
Randomized, parallel group trial. Randomization was centralized with simple randomization with random allocation rule
Settings and conduct
Fifty six neonates with intestinal atresia referred to Ahvaz Imam Khomeini Hospital will be studied. Primary diagnosis will be based on the abdominal distension, absence of meconium excretion, bilious vomiting, Oral intolerance and radiological findings
Participants/Inclusion and exclusion criteria
An inclusion criterion is neonates with intestinal atresia based on the clinical signs and radiographic assessment; The exclusion criterion is neonates with diagnosis of a complication than intestinal atresia
Intervention groups
Fifty six neonates with intestinal atresia will be divided into two comparable groups. In the first group, proximal to anastomosis T-tube enterostomy is performed. In the second group, only conventional end to end anastomosis is performed
Main outcome variables
Interval between surgery and beginning of oral nutrition; Rate of anastomotic leak; Rate of anastomotic stricture; Peritonitis rate after surgery; Duration of improvement of T-tube placement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180811040765N1
Registration date:2018-08-17, 1397/05/26
Registration timing:registered_while_recruiting
Last update:2018-08-17, 1397/05/26
Update count:0
Registration date
2018-08-17, 1397/05/26
Registrant information
Name
Hoda Ilkhani Pak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 2925
Email address
ilkhani.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of effectiveness of proximal to anastomosis T-tube enterostomy versus conventional end to end anastomosis in treatment of neonates with intestinal atresia
Public title
Comparison of efficacy of proximal to anastomosis T-tube enterostomy versus conventional end to end anastomosis in neonates with intestinal atresia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonates with primary diagnosis of intestinal atresia according to the clinical signs and radiographic assessment
Exclusion criteria:
Diagnosis of a complication than atresia after initial evaluations
Age
From 1 day old to 20 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random allocation rule: First the sample size was calculated. Then, the subjects (n=56) are randomly assigned into two groups of intervention and control (each 28). In the random assignment, 28 cards are assigned to intervention and 28 to control group. The cards are randomly and without replacement removed from the box and the sequence is recorded.
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 University of Medical Sciences
Street address
Golestan Blvd., Research deputy, Ahvaz Jundishapur University Of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.AJUMS.REC.1396.1068
Health conditions studied
1
Description of health condition studied
Intestinal Atresia
ICD-10 code
Q41
ICD-10 code description
Congenital absence, atresia and stenosis of small intestine
Primary outcomes
1
Description
Interval between surgery and beginning of oral nutrition
Timepoint
The first day of neonatal oral tolerance
Method of measurement
Daily examinations
2
Description
Rate of anastomotic leak
Timepoint
During hospitalization stay
Method of measurement
Sonographic diagnosis
3
Description
Rate of anastomotic stricture
Timepoint
During hospitalization stay
Method of measurement
Imaging findings
4
Description
Peritonitis rate after surgery
Timepoint
Daily examinations and evaluations
Method of measurement
Clinical signs and blood test
5
Description
Duration of improvement of T-tube placement
Timepoint
On the 3, 5, 7 and 14 days after discharge
Method of measurement
Outpatient examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Primary end-to-end anastomosis with T-tube application
Category
Treatment - Surgery
2
Description
Control group: Only primary end-to-end anastomosis
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahnam Askarpour
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3222 2925
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 Badavi, PhD
Street address
Deputy of Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
33012192
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
Hoda Ilkhani Pak
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61329235893
Email
ilkhanipakhoda@gmail.cim
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahnam Askarpour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric surgery
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61322235292
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
Hoda Ilkhani Pak
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Azadegan Ave., Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61329235893
Email
ilkhanipakhoda@gmail.cim
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available