Protocol summary

Summary
The purpose of this research is to study the effects of the Probiotics in decreasing surgical site infection after colectomy. Eighty patients above 13 years of age and with colorectal cancer, who referred to Razi, Golestan and Emam Khomeini Hospitals during two years of 1390 and 1391, were classified into two groups of "intervention" and "control" by block randomization. The following were excluded from the trial: critically ill patients, patients with central venous catheter, disrupted mucosal barrier, short bowel syndrome, abnormal cardiac valves, prosthetic valves or joints. Those patients of "intervention" group received England-made Balance Capsules; and patients of "control" group received Placebos, both of which were taken 2 doses daily in the period from four days before operation and ten days after. WBC diff, CRP, IL6, and TNF-a in the patients of both groups were checked at the beginning of the observation and 72 hours after operation. And their temperature, pulse rate, respiratory rate, and blood pressure were checked at the beginning of the research and then the first, second, third, tenth and thirtieth day after operation. Likewise, the creation of cellulitis and purulent discharge from operation area in the patients were evaluated at the first, second, third, tenth, and thirtieth day after operation. In addition to the above, mortality, the necessity for admission to ICU and the related duration were evaluated, too.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201304187197N7
Registration date: 2013-05-12, 1392/02/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-12, 1392/02/22
Registrant information
Name
Farid Yousefi
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 5935
Email address
drfayo@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapur University of Medical Sciences
Expected recruitment start date
2012-02-04, 1390/11/15
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of probiotic effect and placebo on reduction of surgical site infection after colectomy
Public title
Evaluation of probiotic effect and placebo on reduction of surgical site infection after colectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Patients older than 13 years old with colorectal cancer that came to Razi, Emam Khomeini and Golestan hospital for colectomy between 1390-1391 Exclusion criteria: 1- critically ill patients 2- patients with central venous catheter 3- disrupted mucosal barrier 4- short bowel syndrome 5- abnormal cardiac valves 6- prosthetic valves 7- prosthetic joints
Age
From 13 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Giving the medicine to the patients was arranged in a double blind method so as to guarantee the minimum of the physician´s personal prejudgment when filling the patients' form and the maximum of the patient´s cooperation. Neither the physician nor the patients had any knowledge about the type of medicine.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahwas Jundishapur University of Medical Sciences
Street address
Vice chancellor for research, Ahwaz Jundishapur University of Medical Sciences
City
Ahwaz
Postal code
Approval date
2012-01-21, 1390/11/01
Ethics committee reference number
5242//د/8/20/پ

Health conditions studied

1

Description of health condition studied
Colorectal cancer
ICD-10 code
c18.9, c19
ICD-10 code description
C18.9 Colon, unspecified, C19 Malignant neoplasm of rectosigmoid junction, C20 Malignant neoplasm of rectum, C21.0 Anus, unspecified

Primary outcomes

1

Description
surgical site infection
Timepoint
beginning of intervention and first, second, third, tenth and thirtieth days after operation
Method of measurement
fever, respiratory rate, pulse rate, pulse rate, cellulitis, dyscharge

Secondary outcomes

1

Description
WBC/diff
Timepoint
beginning of investigation and 72 hours after surgery
Method of measurement
kit

2

Description
IL6
Timepoint
beginning of investigation and 72 hours after surgery
Method of measurement
Bendermed kit

3

Description
TNF-a
Timepoint
beginning of investigation and 72 hours after surgery
Method of measurement
Bendermed kit

4

Description
CRP
Timepoint
beginning of investigation and 72 hours after surgery
Method of measurement
Roch kit

Intervention groups

1

Description
Control group: Placebo was given every 12 hours/ orally from 4 days before through 10 days after operation
Category
Treatment - Drugs

2

Description
Case group: Balance capsule made in England was given every 12 hours/ orally from 4 days before through 10 days after operation
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi, Emam Khomeini and Golestan Hospital
Full name of responsible person
doctor Farzane Behmanesh
Street address
Medical Science Golestan dormitory, Ahwaz, Khoozestan
City
Ahwaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz University of Medical Science
Full name of responsible person
Doctor Mostafa Feqhy
Street address
Jundishapur University, Daneshgah street.
City
Ahwaz
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, Ahwaz University of Medical Science
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
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Doctor Negin Honarvar
Position
Resident
Other areas of specialty/work
Street address
Infectious diseases department, Razi Hospital, Felestin St
City
Ahwaz
Postal code
Phone
+98 61 1221 6840
Fax
Email
dr.nhonarvar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Doctor Farid Yousefi
Position
Assistant professor
Other areas of specialty/work
Street address
Infectious diseases department, Razi Hospital, Felestin St
City
Ahwas
Postal code
Phone
+98 6112
Fax
Email
drfayo@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Doctor Negin Honarvar
Position
Resident
Other areas of specialty/work
Street address
Infectious diseases department, Razi Hospital, Felestin St
City
Ahwaz
Postal code
Phone
+98 61 1221 6840
Fax
Email
dr.nhonarvar@yahoo.com
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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