Evaluation early vs delay staring nutrition after colon resection and anastomosis
Design
50 patients will be selected randomly into two groups from patients undergoing colon resection and anatomists. This is singled blind clinical trial.
Settings and conduct
Patients in control group will be fasted for 4-5 days and afterward liquid diet will be started and gradually changed to normal diet.
in case of negative signs or symptoms of intolerance (Lack of illus) to diet it will be started with normal diet after 48 hours. Patients will be discharged at day 4.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Colon resection and anastomosis
Exclusion criteria: diabeties, immunosuppression and corticosteroid, , hypothyroidism,history of radiotherapy, previous colostomy.
Intervention groups
Early oral feeding will be started after 24 hours in the main group and in case of negative signs or symptoms of intolerance (Lack of illus) to diet it will be started with normal diet after 48 hours. Patients will be discharged at day 4.
Main outcome variables
Nausea and Vomiting
Defecation
Illus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111211008375N15
Registration date:2018-05-31, 1397/03/10
Registration timing:registered_while_recruiting
Last update:2018-05-31, 1397/03/10
Update count:0
Registration date
2018-05-31, 1397/03/10
Registrant information
Name
Seyed Amirkazem Vejdan
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3222 2300
Email address
vejdan_sa@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
2018-04-04, 1397/01/15
Actual recruitment end date
2018-07-06, 1397/04/15
Trial completion date
empty
Scientific title
Evaluation early versus delayed oral feeding on patients undergoing elective colon resection
Public title
Evaluation early versus delayed oral feeding on patients undergoing elective colon resection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing colon resection and anastomosis
Exclusion criteria:
diabetic patient
Patients with immunosuppressive and corticosteroid users
Patients with Psychiatric Problems
Hypothyroid patients
Patients who have undergone another anasomoses besides anastomosis of the colon
Patients undergoing total collectomy
Patients with a history of radiotherapy
Patients who have colostomy been protected
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be performed using balanced block randomization ratio 1:1 by personal unit.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study was administered as a single blinded study to prevent bias for the participants.since there was not any other surgeons in the study center there was no possibility for constructing to double blindness.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee ofbirjand university of medical science.
Street address
Ghaffari St
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2017-02-12, 1395/11/24
Ethics committee reference number
Ir.bums.REC.1396.284
Health conditions studied
1
Description of health condition studied
Early and late feeding
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
nausea and vomiting
Timepoint
Every 4 hours until clearance
Method of measurement
the information gathered from the patients
2
Description
defecation
Timepoint
The patients first defecation after surgery
Method of measurement
The information gathered from the patients
3
Description
illeus
Timepoint
Every 4 hours until clearance
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Early oral feeding will be started after 24 hours in the main group and in case of negative signs or symptoms of intolerance (Lack of illus) to diet it will be started with normal diet after 48 hours. Patients will be discharged at day 4.
Category
Treatment - Other
2
Description
Patients will be fasted for 4-5 days and afterward liquid diet will be started and gradually changed to normal diet. in case of negative signs or symptoms of intolerance (Lack of illus) to diet it will be started with normal diet after 48 hours. Patients will be discharged at day 4.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Seyyed AmirKazem Vejdan
Street address
Taleghani street
City
Birjand
Province
South Khorasan
Postal code
9714811151
Phone
+98 56 3222 2300
Email
vejdan_sa@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tuba Kazemy
Street address
Ghaffari Street , Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3244 0388
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
دانشگاه علوم پزشکی بیرجند
Position
Specialist in general surgery, Associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Imam Reza hospital
City
Birjand
Province
South Khorasan
Postal code
9714811151
Phone
+98 56 3222 2300
Email
vejdan_sa@bums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Amir Kazem Vejdan
Position
Specialist in general surgery, Associate professor