The effects of perioperative treatment by probiotics in decreasing the complications of colorectal surgery
Design
All patients referred to surgery wards of Tabriz University of medical sciences in year 2017 for colorectal surgery are randomized between to intervention (who receives probiotic) and control group (who doesn't receive probiotic) and followed for 30 days after the operation for the complications of surgery.
Settings and conduct
Preoperative bowel preparation is done in both intervention and control group by oral polyethylene glycol, erythromycin and metronidazole and intravenous cefazolin. Cefazolin is continued for 48 hours after the operation or changed by the surgeon opinion due to intraoperative spillage. Intervention group will receive daily Familact capsule as the probiotic drug from 7 days before the operation till a total of 30 days. All patients will be followed for 30 days after the operation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: need for any elective colorectal surgery;surgery is done by an attending surgeon; good nutritional status
Exclusion criteria: no consent to enter the study; small or large bowel obstruction; anticoagulant consumption; ASA class IV; inflammatory bowel disease; history of chemotherapy; transplant recipients; liver cirrhosis; antibiotic consumption in the week before surgery; steroid consumption; diabetes mellitus; pregnancy or breastfeeding; immunodeficiency of any cause
Intervention groups
Intervention group are those patients who receive probiotic drug and the control group is those who don't receive the drug.
Main outcome variables
Age; sex; duration of operation; type of surgery; first time of gas passing; tolerance of oral feeding; total hospital stay; surgical site infection; anastomosis rupture; wound dehiscence; diarrhea; pulmonary infection; urinary tract infection; sepsis; mortality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140203016473N9
Registration date:2018-05-12, 1397/02/22
Registration timing:retrospective
Last update:2018-05-12, 1397/02/22
Update count:0
Registration date
2018-05-12, 1397/02/22
Registrant information
Name
Farzad Kakaei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 1317
Email address
fkakaei@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-20, 1397/06/29
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2018-03-20, 1396/12/29
Trial completion date
empty
Scientific title
The effects of perioperative probiotic treatment on postoperative complications after colorectal surgery-a randomized clinical trial
Public title
The effects of perioperative probiotic treatment after colorectal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Need for any elective colorectal surgery
Nurgery is done by an attending surgeon
Good nutritional status
Exclusion criteria:
No consent to enter the study
Small or large bowel obstruction
Anticoagulant consumption
ASA class IV
Inflammatory bowel disease
History of chemotherapy
Transplant recipients
Liver cirrhosis
Antibiotic consumption in the week before surgery
Steroid consumption
Diabetes mellitus
Pregnancy or breastfeeding
Immunodeficiency of any cause
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomized between two study (who will receive the probiotic) and control (who will not receive the probiotic) groups by the random numbers produced by the website: www.randomizer.org
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 Tabriz University of medical sciences
Street address
Azadi Ave, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.TBZMED.REC.1396.1304
Health conditions studied
1
Description of health condition studied
Malignant diseases of colon
ICD-10 code
C18
ICD-10 code description
Malignant neoplasm of colon
2
Description of health condition studied
Benign diseases of the colon, rectum, anus and anal canal
ICD-10 code
D12
ICD-10 code description
Benign neoplasm of colon, rectum, anus and anal canal
3
Description of health condition studied
Foreign body in colon
ICD-10 code
T18.4XXA
ICD-10 code description
Foreign body in colon, initial encounter
4
Description of health condition studied
Other specified diseases of intestine
ICD-10 code
K63.8
ICD-10 code description
Other specified diseases of intestine
Primary outcomes
1
Description
Anastomosis rupture
Timepoint
Daily till 30 days after the operation
Method of measurement
Physical examination
2
Description
Surgical site infection
Timepoint
Daily till 30 days after the operation
Method of measurement
Physical examination
3
Description
Fascia dehiscence
Timepoint
Daily till 30 days after the operation
Method of measurement
Physical examination
4
Description
Pulmonary infection
Timepoint
Daily till 30 days after the operation
Method of measurement
Chest x-ray if clinically indicated
5
Description
Urinary infection
Timepoint
Daily till 30 days after the operation
Method of measurement
Urinalysis if clinically indicated
6
Description
Total duration of hospital stay
Timepoint
Daily
Method of measurement
Total duration of hospital stay till discharge
7
Description
Mortality
Timepoint
Daily
Method of measurement
Report of death by attending physician
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pre- and postoperative treatment by oral probiotic drug after colorectal surgery
Category
Treatment - Drugs
2
Description
Control group: Routine pre- and postoperative treatment of colorectal surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Mohammadreza Shahrasbi
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614695
Phone
+98 41 3334 7054
Fax
+98 41 3334 1317
Email
Mohammadrezashahrasbi@yahoo.com
Web page address
Http://imamreza.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5169664339
Phone
+98 41 3335 7310
Fax
+98 51 6661 4695
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614695
Phone
+98 41 3334 1317
Email
fkakaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614695
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
Fkakaei@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzad Kakaei
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614695
Phone
+98 413341317
Email
fkakaei@yahoo.com
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