Protocol summary

Summary
Target: Comparison of the effect of semi sitting and supine position effect on serum levels of inflammatory factors after appendectomy in Dezful large hospital and Imam Ali(AS) Hospital of Andimeshk in 2014. Inclusion criteria: All patients with the diagnosis of acute appendicitis underwent appendectomy based on the history, physical examination and paraclinic findings, and absence of underlying disease that causes high inflammatory factors before surgery. Exclusion criteria: Patients with diabetes, patients who had normal appendix. In this study, 120 patients by blocked randomization will be put into four groups (each group consisted of 30 people). The first intervention group patients after surgery in the supine position will receive three doses of antibiotics, In the second group of patients after surgery in the supine position will receive one dose of antibiotics, The third group of patients after surgery with three doses of antibiotics will have a semi-upright position and Four patients in the intervention group after surgery with a dose of antibiotics will have a semi-upright position. Then all of them will be evaluated 2 hours before, and 2 and 24 hours after surgery for inflammatory markers (CRP, ESR, leukocytes, and neutrophils) using blood samples, as well as temperature. The expected outcome of the study are the average amount of WBC, ESR, CRP, neutrophil and temperatures in the four groups at 24 hours after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014102819733N1
Registration date: 2015-11-28, 1394/09/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-11-28, 1394/09/07
Registrant information
Name
Mohammad Maniey
Name of organization / entity
Dezful University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 4323 0999
Email address
maniey.m@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Dezful University of Medical Sciences
Expected recruitment start date
2016-02-14, 1394/11/25
Expected recruitment end date
2016-10-31, 1395/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of semi sitting and supine position on serum levels of inflammatory factors in patients after appendectomy
Public title
Effect of semi sitting position on inflammatory factors after appendectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria : All patients on the basis of history and physical examination and laboratory findings; the diagnosis of acute appendicitis underwent appendectomy be; People aged 10 to 50 years; Not addicted to drugs; there is no underlying disease that is caused by elevated inflammatory markers before surgery; Consent to participate in the study and blood; having full consciousness baseline; If the body's inflammatory factors in sample 2 hours before and 2 hours after surgery are higher than normal. Exclusion Criteria : Diabetes; cancer; patients who had normal appendicitis; Patients with a history of previous infections and antibiotic use during the past week, a history of allergy to cephalosporins; Patients receiving immunosuppressive such as corticosteroids and cytotoxic drugs or taking anti-inflammatory drugs; Patients release from the hospital earlier than 24 hours.
Age
From 10 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Ethics committee of Dezful University of Medical Sciences
Street address
Next The Police Department, Azadegan Boulevard, Dezful
City
Dezful
Postal code
6461653476
Approval date
2015-07-29, 1394/05/07
Ethics committee reference number
IR.DUMS.REC.1394.10

Health conditions studied

1

Description of health condition studied
Acute Appendicitis
ICD-10 code
K35
ICD-10 code description
Acute Appendicitis

Primary outcomes

1

Description
CRP
Timepoint
2 Hours Before; 2 And 24 Hours After Intervention (reposition)
Method of measurement
Blood Samples, Immuno-agglutination Assay

2

Description
ESR
Timepoint
2 Hours Before; 2 And 24 Hours After Intervention (reposition)
Method of measurement
Blood Samples, Green Blot Method

3

Description
Leukocytes
Timepoint
2 Hours Before; 2 And 24 Hours After Intervention (reposition)
Method of measurement
Blood Samples, Cell Count Method

4

Description
Neutrophils
Timepoint
2 Hours Before; 2 And 24 Hours After Intervention (reposition)
Method of measurement
Blood Samples, Cell Count Method

5

Description
Temperature
Timepoint
2 Hours Before; 2 And 24 Hours After Intervention (reposition)
Method of measurement
Mercury Thermometer

Secondary outcomes

empty

Intervention groups

1

Description
1)The first intervention group patients after surgery in the supine position and will receive three doses of antibiotics as directed by physician and 2 Hours, 2 and 24 hours after surgery for inflammatory markers CRP, ESR, leukocytes, neutrophils will be evaluated using blood samples, as well as temperature.
Category
Prevention

2

Description
2)In the second intervention group patients after surgery in the supine position and will receive one dose of antibiotics as directed by their physician and 2 Hours, 2 and 24 hours after surgery for inflammatory markers CRP, ESR, leukocytes, neutrophils will be evaluated using blood samples, as well as temperature.
Category
Prevention

3

Description
3)In the third study, patients received three doses of antibiotics after surgery, according to the doctor and have a semi-upright position and 2 Hours, 2 and 24 hours after surgery for inflammatory markers CRP, ESR, leukocytes, neutrophils will be evaluated using blood samples, as well as temperature.
Category
Prevention

4

Description
4)In the fourth study, patients after surgery with a dose of antibiotics will have a semi-upright position and 2 Hours, 2 and 24 hours after surgery for inflammatory markers CRP, ESR, leukocytes, neutrophils will be evaluated using blood samples, as well as temperature.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dezful Large Hospital
Full name of responsible person
Mohammad Maniey
Street address
Dezful Large Hospital, In Front of Armored Corps 292, Beginning of The Dezful-Andimeshk Road, Dezful
City
Dezful

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Dezful University of Medical Sciences
Full name of responsible person
Fereydoun Niroozad
Street address
Dezful University of Medical Sciences, Next The Police Department, Azadegan Boulevard, Dezful
City
Dezful
Grant name
معاونت پژوهشی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Dezful 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
Dezful University of Medical Sciences
Full name of responsible person
Mohammad Maniey
Position
MSc in Nursing
Other areas of specialty/work
Street address
Next The Police Department, Azadgan Alley, Dezful
City
Dezful
Postal code
Phone
+98 64 1626 9041
Fax
Email
maniey.m@dums.ac.ir; ymadmoli@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Yaghoob Madmoli
Position
Nursing Student
Other areas of specialty/work
Street address
Martyr Khodadady Alley, Number Eight, Masjed Soleyman
City
Masjed Soleyman
Postal code
6491853954
Phone
+98 61 4323 0999
Fax
Email
nursenanda1390@gmail.com; ymadmoli@gmail.com
Web page address
www.nursenanda.blogfa.com

Person responsible for updating data

Contact
Name of organization / entity
Dezful University of Medical Sciences
Full name of responsible person
Yaghoob Madmoli
Position
Nursing Student
Other areas of specialty/work
Street address
Martyr Khodadady Alley, Number Eight, Masjed Soleyman
City
Masjed Soleyman
Postal code
6491853954
Phone
+98 61 4323 0999
Fax
Email
nursenanda1390@gmailcom; ymadmoli@gmail.com
Web page address
www.nursenanda.blogfa.com

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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