Protocol summary

Summary
Objectives: comparing surgical outcomes of early and late oral feeding in children undergoing intestinal anastomosis. Participants and major eligibility criteria: 66 children aged one month to 12 years in the Imam Reza hospital in Kermanshah are undergoing intestinal resection-anastomosis will be studied; Exclusion criteria included underling diseases, septic shock, severe postoperative ileus (abdominal distention with vomiting), a large difference in size between two ends of the bowel during surgery, complicated surgery, anemia and lack of consistency between weight and age. Design and interventions: In this randomized clinical trial, before surgery, patients are randomly assigned to one of the following groups:In the early feeding group, at first day water and serum dextrose and 2 days after surgery, oral intake of milk and other liquids will begin. In late feeding group, at second day total parental nutrition (TPN) will begin and 5 days after surgery, patients will begin a liquid diet. If appropriate tolerated liquid diet, regular diet gradually will begin. Main outcomes: Patients during the hospital stay will be visited every 12 hours. Duration of hospital stay, time to first defecation and complications after surgery (postoperative fever, nausea, vomiting, abdominal jugular, pneumonia, infections and open incision site) and the cost of hospital patients in both groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107066964N1
Registration date: 2012-02-16, 1390/11/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-02-16, 1390/11/27
Registrant information
Name
Bahram Azizi
Name of organization / entity
Kermanshah university of medical sciences and health services
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6309
Email address
dr.ba.azizi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2011-11-06, 1390/08/15
Expected recruitment end date
2012-06-04, 1391/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of the outcomes of early and late oral feeding in intestinal anastomosis surgeries in children
Public title
The comparative study of the outcomes of early and late oral feeding in intestinal anastomosis surgeries in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children ranging from one month to 12 years in the imam Reza hospital undergoing surgery with intestinal resection and anastomosis will be enrolled; Exclusion criteria included underling diseases; septic shock; severe postoperative ileus (abdominal distention with vomiting); a large difference in size between two ends of the bowel during surgery; complicated surgery; anemia and lack of consistency between weight and age.
Age
To 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
N/A
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
Ethic committee Kermanshah University of Medical Sciences
Street address
Build No. 2 of Kermanshah University of Medical Sciences, Shahid Beheshti Blv, Kermanshah
City
Kermanshah
Postal code
Approval date
2011-06-27, 1390/04/06
Ethics committee reference number
پ/7/420/14127

Health conditions studied

1

Description of health condition studied
Intestinal resection and anastomosis
ICD-10 code
K91.9
ICD-10 code description
Postprocedural disorder of digestive system, unspecified

Primary outcomes

1

Description
Onset time of defecation
Timepoint
every 12h in 5 days post-operation
Method of measurement
Every12 h visits

2

Description
nausea and vomiting and post operation complications
Timepoint
every 12h in 5 days post-operation
Method of measurement
every 12 h visits

Secondary outcomes

1

Description
duration of hospitalization
Timepoint
After patients discharge
Method of measurement
Evaluation of patient document

2

Description
costs of hospitalization
Timepoint
After patients discharge
Method of measurement
Evaluation of patient document

Intervention groups

1

Description
In the early feeding group, at first day water and serum dextrose and 2 days after surgery, oral intake of milk and other liquids will begin.
Category
Treatment - Other

2

Description
In late feeding group, at second day total parental nutrition (TPN) will begin and 5 days after surgery, patients will begin a liquid diet. If appropriate tolerated liquid diet, regular diet gradually will begin.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital of Kermanshah
Full name of responsible person
Bahram Azizi
Street address
Imamreza hospital, Parastar Blv, Kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Build No. 2 of Kermanshah University of Medical Sciences, Shahid Beheshti Blv
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Bahram Azizi
Position
Resident of general surgery
Other areas of specialty/work
Street address
No. 16, District 124, Vahdat Blv
City
Kermanshah
Postal code
6714785474
Phone
+98 83 1427 6309
Fax
+98 83 1427 6301
Email
azizi.ba54@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Omid Amanollahi
Position
Pediatric surgeon
Other areas of specialty/work
Street address
No. 44, District 12, Nastaran St, Shahid Jafari Blv
City
Kermanshah
Postal code
Phone
+98 83 1427 6301
Fax
+98 42 76301
Email
Oamanollahi@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Bahram Azizi
Position
Resident of general surgery
Other areas of specialty/work
Street address
No. 16, District 124, Vahdat Blv
City
Kermanshah
Postal code
Phone
+98 83 1427 6309
Fax
+98 83 1427 6301
Email
azizi.ba54@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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