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The effect of early oral nutrition on decreasing the complications and hospitalization duration following laparoscopic cholecystectomy surgery

Protocol summary

Summary
The main aim of this study is to evaluate the effect of early oral nutrition on decreasing the complications and hospitalization duration following laparoscopic cholecystectomy surgery. The study is a single-centre, randomized interventional clinical trial in which, 100 patients who are candidate for laparoscopic cholecystectomy at Imam Khomeini hospital of Ardabil in 2016-17 are randomly allocated into two equal groups of intervention and control. Inclusion criteria are as follows: persons undergoing laparoscopic cholecystectomy, aged 15 years old or older, consent to the study, and no associated malnutrition. Exclusion criteria are as follows: Age less than 15 years, associated malnutrition, severe associated diseases, and emergent cases. The studied intervention is initiation of post-operative oral nutrition. The oral nutrition is initiated 1 hour after full recovery of patients from anesthesia in the intervention group and after 24 hours of surgery in the control group. The study outcomes are vomiting, nausea, hearing of bowel sound, flatus passing, stools passing, and duration of admission.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017081434660N1
Registration date: 2017-09-04, 1396/06/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-04, 1396/06/13
Registrant information
Name
Masoud Nourani
Name of organization / entity
Ardabil University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 819 3539
Email address
m.nourani@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research, Ardabil medical university, Ardabil
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-07-23, 1396/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of early oral nutrition on decreasing the complications and hospitalization duration following laparoscopic cholecystectomy surgery
Public title
The effect of early oral nutrition on decreasing the complications and hospitalization duration following laparoscopic cholecystectomy surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: persons undergoing laparoscopic cholecystectomy; aged older than 15 years; consent to the study; and no associated malnutrition. Exclusion criteria: Age less than 15 years; associated malnutrition; severe associated diseases; and emergent cases.
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: 100
Randomization (investigator's opinion)
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
Ethic Committee Of Ardabil University Of Medical Sciences
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardabil
Postal code
5615751147
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.ARUMS. REC.1395.133

Health conditions studied

1

Description of health condition studied
laparoscopic cholecystectomy
ICD-10 code
K80.1
ICD-10 code description
Calculus of gallbladder with other cholecystitis

Primary outcomes

1

Description
nausea
Timepoint
every 6 hours until hospital discharge of patients
Method of measurement
Asking from patients

2

Description
vomiting
Timepoint
every 6 hours until hospital discharge of patients
Method of measurement
Asking from patients

3

Description
hearing of bowel sound
Timepoint
Every hour
Method of measurement
Hearing of bowel sound by stetoscope

4

Description
flatus passing
Timepoint
every 1 hour
Method of measurement
Asking from patients

5

Description
stools passing
Timepoint
every 1 hour
Method of measurement
Asking from patients

6

Description
duration of admission
Timepoint
after hospital discharge of patients
Method of measurement
Days of hospitalization

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Initiation of oral nutrition 1 hour after full recovery of patient from anesthesia
Category
Treatment - Other

2

Description
Control group: Initiation of oral nutrition 24 hours after surgery
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ardabil City
Full name of responsible person
Masoud Nourani
Street address
Imam Khomeini Hospital , Ataee St, Ardabil
City
Ardabil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Ardabil University of Medical Sciences
Full name of responsible person
Dr Hadi Piri Dogahe
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardabil
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, Ardabil 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
Ardabil University Of Medical Sciences
Full name of responsible person
Masoud Nourani
Position
Medical student
Other areas of specialty/work
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardabil
Postal code
5619853141
Phone
+45 5512006
Fax
Email
M.Nourani@arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Saeid Sadeghieh Ahari
Position
Associate Professor/ Public Health
Other areas of specialty/work
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardabil
Postal code
5615751147
Phone
+98 45 3352 2083
Fax
Email
S.Sadeghi@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University Of Medical Sciences
Full name of responsible person
Masoud Nourani
Position
Medical Student
Other areas of specialty/work
Street address
Ardabil Complex Univesity, Daneshgah st., Ardabil, Ardabil Province.
City
Ardabil
Postal code
5619853141
Phone
+98 455512006
Fax
Email
M.Nourani@arums.ac.ir
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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