Comparison of the Consequences of Early Oral Nutrition by Late Oral Feeding in Patients with Elective Gastrointestinal Surgery
Design
Clinical trial with control group, with parallel group, randomized
Sample size 200 people
Randomization in sealed envelope
Settings and conduct
In the field of elective gastrointestinal surgery, Qazvin Hospital, Department of Surgery, the patients were randomly divided into two equal groups of recipients of postoperative early nourishment (24 hours) and control group (under late feeding (5 to 7 days after surgery) And examined
Participants/Inclusion and exclusion criteria
patients undergoing elective digestive surgery
Exclusion criteria include certain past medical history such as cirrhosis and roheumatologic disease , taking immonosuppressive drug, malnutrition patient
Intervention groups
Patients were randomly divided into two equal groups of recipients of early-onset nutrition after surgery (24 hours) and control group (under late breastfeeding (5 to 7 days after surgery). In the early feeding group, patients 24 hours after surgery will receive oral fluids, and in the delayed feeding group, a fluid regimen will begin for patients from day 5 after surgery.Patients will be visited every 12 hours during hospitalization and will be evaluated for signs and symptoms of intestinal and abdominal distension, as well as the onset of stool and gastrointestinal symptoms such as nausea and vomiting
Main outcome variables
Anastomotic leaks ; duration of admission ; serum intake ; Incidence of acute edema of the lungs ; infection ; nausea and vomiting ; abdominal pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190529043758N1
Registration date:2019-07-28, 1398/05/06
Registration timing:retrospective
Last update:2019-07-28, 1398/05/06
Update count:0
Registration date
2019-07-28, 1398/05/06
Registrant information
Name
Bahram Shaghaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3379 0620
Email address
bahram.shaghaghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the outcomes of early oral feeding with delayed oral feeding in patients undergoing elective GI surgery
Public title
Comparison early oral feeding with delayed oral feeding in elective GI surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients undergoing elective digestive surgery (including stomach, small intestine, colon).
Exclusion criteria:
certain past medical history such as cirrhosis and rheumatologic disease
taking immunosuppressive drugs
malnutrition patients
Age
From 20 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual, sealed envelope
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 Qazvin University of Medical Sciences
Street address
Qazvin - Shahid Bahonar Blvd. - Qazvin University of Medical Sciences
City
qazvin
Province
Qazvin
Postal code
15315-34199
Approval date
2018-10-17, 1397/07/25
Ethics committee reference number
ir.qums.rec.1397.162
Health conditions studied
1
Description of health condition studied
Jejunojejunostomy
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Loop gastrojejunostomy + Braun jejunojejunostomy
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Ileoileostomy
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Total colectomy
ICD-10 code
ICD-10 code description
5
Description of health condition studied
choldoduodenostomy
ICD-10 code
ICD-10 code description
6
Description of health condition studied
Jejunoileal anastomosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of leaked anastomosis
Timepoint
Daily after operation until discharge
Method of measurement
Physical examination
Secondary outcomes
1
Description
Incidence of acute edema of the lungs
Timepoint
24 hours and 5 days after surgery
Method of measurement
Physical examination
2
Description
Incidence of infection
Timepoint
24 hours and 5 days after surgery
Method of measurement
Physical examination
3
Description
Incidence of nausea and vomiting
Timepoint
24 hours and 5 days after surgery
Method of measurement
Physical examination
4
Description
Incidence of abdominal pain
Timepoint
24 hours and 5 days after surgery
Method of measurement
Physical examination
5
Description
The amount of received serum
Timepoint
24 hours and 5 days after surgery
Method of measurement
Liters
6
Description
The number of hospitalization
Timepoint
24 hours and 5 days after surgery
Method of measurement
date
Intervention groups
1
Description
Intervention group: The oral nutrition begins 24 hours after anastomosis and progresses gradually. (first 24 hours)
Category
Treatment - Surgery
2
Description
Control group: The oral nutrition begins 5 days after anastomosis and progresses gradually. (5 days later)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
velayat hospital
Full name of responsible person
bahram shaghaghi
Street address
Qazvin University of Medical Sciences - Shahid Bahonar Blvd
City
qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
amir peymani
Street address
Qazvin University of Medical Sciences,Shahid Bahonar Blvd
City
qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?