The purpose of this non-randomized, multicenter trial is to compare reduction of abdominal contents of neonates with Gastroschisis in ward without general anesthesia and in operating room under general anesthesia. A total of 30 neonates born with Gastroschisis will be studied in pediatric centers of Shaheed Beheshti, Tabriz, Mashhad, Qazvin, and Shiraz Medical Universities. For the neonates in the first group, immediately after admission in the centers and initial Supportive treatment, abdominal contents are reduced in the ward without the use of general anesthesia while for the second group the abdominal contents are reduced with conventional technique in the operating room under general anesthesia. Hospitalization period, NICU stay, the need for ventilator and anesthesia, the later need for any surgical procedure, duration of receiving TPN and complete intestinal nutrition will be compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012085342N1
Registration date:2011-04-23, 1390/02/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-23, 1390/02/03
Registrant information
Name
Kamrooz Pouryousef
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
pouryousefk@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In ward reduction compared with traditional reduction under general anesthesia in gastroschisis neonates (short term result)
Public title
Comparison of reduction of abdominal content in the ward with reduction under general anesthesia in the operating room in neonates with gastroschisis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: neonates born with gastroschisis
Exclusion criteria: presence of major anomalies, peritonitis, intestinal atresia
Age
To 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not 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
Tabriz University Of Medical Sciences and Health Services
Street address
Golgasht Ave.
City
Tabriz
Postal code
Approval date
2011-01-30, 1389/11/10
Ethics committee reference number
8957/4/5
Health conditions studied
1
Description of health condition studied
Gastroschisis
ICD-10 code
Q79.3
ICD-10 code description
Gastroschisis
Primary outcomes
1
Description
Duration of receiving TPN
Timepoint
During hospitalization
Method of measurement
Time to beginning of entral feeding, in days
2
Description
Time to onset of entral feeding
Timepoint
During hospitalization
Method of measurement
time to discontinuation of TPN in days
3
Description
Need for further surgical procedure
Timepoint
During hospitalization
Method of measurement
Undergoing any surgical procedure
4
Description
Hospital stay
Timepoint
admission and discharge
Method of measurement
in days
5
Description
NICU stay
Timepoint
Admission in and transfer from neonatal ward
Method of measurement
in days
6
Description
Need for ventilation and its duration
Timepoint
connection to ventilator and Out of ventilator
Method of measurement
in days
7
Description
Need for general anesthesia under reduction
Timepoint
During the intervention
Method of measurement
Receiving general anesthesia
Secondary outcomes
1
Description
Saving in health facilities
Timepoint
During the study
Method of measurement
Reduction the use of facilities
2
Description
Reduce costs
Timepoint
at end of study
Method of measurement
calculation of costs
Intervention groups
1
Description
Control group: Reduction of abdominal contents in the operating room under general anesthesia with conventional technique
Category
Treatment - Surgery
2
Description
Intervention group: Reduction of abdominal contents in the neonatal ward without general anesthesia
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Hospital Of Tabriz
Full name of responsible person
Dr. Saeed Aslanabadi, Associate Professor of Pediatric Surgery
Street address
Sheshglan Ave.
City
Tabriz
2
Recruitment center
Name of recruitment center
Pediatric Education and Treatment Center Of Shahid Beheshti University Of Medical Sciences and Healt
Full name of responsible person
Dr. Ahmad Khalegh Nejad Tabari, Professor of Pediatric Surgery
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Children's Hospital Of Shiraz
Full name of responsible person
Dr. Hamid Forotan, Professor Of Pediatric Surgery
Street address
City
Shiraz
4
Recruitment center
Name of recruitment center
Children's Hospital Of Mashhad
Full name of responsible person
Dr. Mehran Hiradfar, Associate Professor of Pediatric Surgery
Street address
City
Mashhad
5
Recruitment center
Name of recruitment center
Children's Hospital Of Gazvin
Full name of responsible person
Dr. Saeed Tarlan- Associate Professor Of Pediatric Surgery
Street address
City
Gazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz Medical University Of scienes and Health Services
Full name of responsible person
Miss Magami
Street address
Research Center of Medicine Faculty, Golgasht Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz Medical University Of scienes and Health Services
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
Tabriz University Of Medical Sciences and Health Services
Full name of responsible person
Dr. Kamrooz Pouryousef
Position
Rezident Of General Surgery
Other areas of specialty/work
Street address
General Surgery Groap, Imam Reza Hospital -Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
pouryousefk@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Full name of responsible person
Dr. Kamrooz Pouryousef
Position
Resident Of General Surgery
Other areas of specialty/work
Street address
Imam Reza Hospital ,Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
pouryousefk@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Kamrooz Pouryousef
Position
Resident Of General Surgery
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
pouryousefk@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)