The purpose of this study is to compare inpatient outcomes in two types of early and late oral nutrition in surgical intestinal anastomsis cases. The study will be conducted single-blind in 60 patients who are operated for intestinal anastomsis. The patients will be divided into two groups randomly. Inclusion critera for the study would be intestinal anastomosis in elective surgical patients, no associated surgical or medical disease, patient's consent to the study and no associated malnutrition. Exclusion criteria would be age over 75 years or less than 15 years of age, associated malnutrition, severe associated diseases, emergent cases, intestinal obstruction or peritonitis. The studied intervention would be initiation of post-operative oral nutrition. The oral nutrition will be initiated after 24 hours in the first group and after 4 days in the second group. The studied outcomes would be abdominal pain, abdominal distension, vomitting and nausea, duration of admission and early complications including leak & dehisence of anastomosis, mesentric emboli and wound infection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108067238N1
Registration date:2011-09-10, 1390/06/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-10, 1390/06/19
Registrant information
Name
Yaghoub Oroji
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
orojiy@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison hospital outcome of early oral feeding and late oral feeding in elective intestinal anastomosis in surgical cases
Public title
Comparison hospital outcome of early oral feeding and late oral feeding in elective intestinal anastomosis in surgical cases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion critera: intestinal anastomosis in elective surgical patients; no associated surgical or medical disease; patient's consent to the study; no associated malnutrition
Exclusion criteria: age over 75 years or less than 15 years of age; associated malnutrition; severe associated diseases; emergent cases, intestinal obstruction or peritonitis
Age
From 15 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Street address
Golgasht St.
City
Tabriz
Postal code
Approval date
2011-06-28, 1390/04/07
Ethics committee reference number
42755/5
Health conditions studied
1
Description of health condition studied
Need for intestinal anastomosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Distension
Timepoint
First to fifth post-operative days
Method of measurement
History & Physical Examination
Secondary outcomes
1
Description
Abdominal pain
Timepoint
First to fifth post-operative days
Method of measurement
History
2
Description
Vomitting & nausea
Timepoint
First to fifth post-operative days
Method of measurement
History
3
Description
Duration of admission
Timepoint
Days in hospital
Method of measurement
Counting days
4
Description
Early complications
Timepoint
First to fifth post-operative days
Method of measurement
History, physical examination and diagnostic techniques
Intervention groups
1
Description
Initiation of oral nutrition at first 24 hours in first group
Category
Other
2
Description
Initiation of oral nutrition after 4 days in second group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Street address
City
Tabriz
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Street address
City
Tabriz
3
Recruitment center
Name of recruitment center
Amir-al-Momenin Hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tanriz University of Medical Sciences
Full name of responsible person
Dr. A.R. barband
Street address
Sina Hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tanriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. A.R. Barband
Position
General Surgeon
Other areas of specialty/work
Street address
Department of Surgery, Sina Hospital
City
Tabriz
Postal code
Phone
+98 914 113 0525
Fax
Email
alibarband@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. A.R. Barband
Position
General Surgeon
Other areas of specialty/work
Street address
Department of Surgery, Sina Hospital
City
Tabriz
Postal code
Phone
+98 914 113 0525
Fax
Email
alibarband@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Y. Oroji
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Department of General Surgery, Imam Reza Hospital
City
Tabriz
Postal code
51664
Phone
+98 41 1334 1317
Fax
Email
OROJIY@TBZMED.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)