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The effect of nutritional guidelines on the gastrointestinal complications control among patients with open heart surgery

Protocol summary

Study aim
Prevention of gastrointestinal complications among patients after open heart surgery using the nutritional guidelines.
Design
A non-randomized clinical trial with control group, without blinding
Settings and conduct
The location of the study is Baqietollah Hospital. Patients are selected by available sampling method. At first, control group samples are examined for postoperative gastrointestinal complications. After completing the control group sampling, in the same way, patients in the intervention group enter the study and receive intervention. Then they are examined for digestive complications.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 30-75 years old, body mass index less than 30, First time open heart surgery. Non-inclusion criteria: Emergency surgery, previous gastrointestinal problems (such as constipation, diarrhea, chronic abdominal distension, peptic ulcer), Restrictive motor problems, Specific food allergies, long-term mechanical ventilation (greater than 24 hours), Hypotension and the need for hemodynamic support, requiring re-operation
Intervention groups
Intervention group: A nutrition protocol that is developed based on the opinion of the heart surgeon, anesthesiologist, nutritionist and traditional medicine is taught to the patient and their families in two sessions of 1.5 hours. The nutrition protocol is used by the patient from the preoperation time until the discharge. Control group: Control group did not receive intervention.
Main outcome variables
Nausea, vomiting, Abdominal flatulence, Constipation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190422043349N1
Registration date: 2019-08-05, 1398/05/14
Registration timing: registered_while_recruiting

Last update: 2019-08-05, 1398/05/14
Update count: 0
Registration date
2019-08-05, 1398/05/14
Registrant information
Name
zari gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8272 3295
Email address
stu.gholami.zgh@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of nutritional guidelines on the gastrointestinal complications control among patients with open heart surgery
Public title
The role of nutritional protocol on gastrointestinal complications of patients undergoing open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 30-75 years BMI ≤ 30 first-time open heart surgery
Exclusion criteria:
Previous GI problems such as constipation, diarrhea, chronic abdominal distension, peptic ulcer. Presence of food allergies Prolonged mechanical ventilation (longer than 24 hours) Restrictive motor problems Hypotension and the need for hemodynamic support Need surgery again
Age
From 35 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, No. 26, South Sheikh Bahaei St., Mollasadra Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2019-02-12, 1397/11/23
Ethics committee reference number
IR.BMSU.REC.1397.253

Health conditions studied

1

Description of health condition studied
open heart surgery
ICD-10 code
Z95.1
ICD-10 code description
Presence of aortocoronary bypass graft

Primary outcomes

1

Description
Nausea
Timepoint
Immediately after the open heart surgery until the day of discharge
Method of measurement
Gastrointestinal Evaluation Checklist

2

Description
Vomiting
Timepoint
Immediately after the open heart surgery until the day of discharge
Method of measurement
Gastrointestinal Evaluation Checklist

3

Description
Constipation
Timepoint
Immediately after the open heart surgery until the day of discharge
Method of measurement
Gastrointestinal Evaluation Checklist

4

Description
flatulency
Timepoint
Immediately after the open heart surgery until the day of discharge
Method of measurement
Gastrointestinal Evaluation Checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Training of nutrition guideline (approved by ten experts of Baqiyatallah University of Medical Sciences) in two three-hour sessions to the patient, the patient's family and nursing staff. Then performing this guideline by the patient in three steps before surgery, post operative and before discharge.
Category
Treatment - Other

2

Description
Control group: No training was provided
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Zari Gholami
Street address
Baqiyatallah Hospital, Molla sadra Street,Vanak Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
stu.gholami.zgh@bmsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Morteza Khaghanizadeh
Street address
Baqiyatallah University of Medical Sciences, No. 26, South Sheikh Bahaei St, Mollasadra Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Fax
+98 21 8860 0047
Email
stu.gholami.zgh@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Zari Gholami
Position
Masters student of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 5, Third closed alley, Borajali Alley, Imam Hussein Street, Vardavard
City
Tehran
Province
Tehran
Postal code
350502320000
Phone
+98 21 8805 0435
Email
stu.gholami.zgh@bmsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Zari Gholami
Position
Student of nursing mastery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 5, Third closed alley, Borajali Alley, Imam Hussein Street, Vardavard
City
Tehran
Province
Tehran
Postal code
350502320000
Phone
+98 21 8805 0435
Email
stu.gholami.zgh@bmsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Zari Gholami
Position
Master of nursing student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 5, Third closed alley, Borajali Alley, Imam Hussein Street, Vardavard
City
Tehran
Province
Tehran
Postal code
350502320000
Phone
+98 21 8805 0435
Email
stu.gholami.zgh@bmsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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