Laparoscopic cholecystectomy surgery component cleaning process is considered contaminated and the use of antibiotics in open surgery is recommended. Method for preventing nosocomial infections, we consider the effect of cefazolin administered in patients scheduled for elective laparoscopic cholecystectomy to assess. The candidates in the low-risk group. Patients aged 74-20 years with the condition of common bile duct stones, obstructive jaundice and acute cholecystitis are enrolled. In this clinical trial, 100 patients were selected, after obtaining informed consent from the patient and the surgeon accidentally by a nurse and without notice in the two groups (50 each) are prescribed and non-prescribed antibiotics. Criteria for surgical site infection: pain, swelling, redness, purulent discharge from the wound, diagnosed by the surgeon. Other infectious complications include intra-abdominal infections, peritonitis or abscess, surgical site after surgery and confirmed paraclinical experiments to be the other most commonly diagnosed as other infectious complications are reported .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013070413865N1
Registration date:2014-04-28, 1393/02/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-28, 1393/02/08
Registrant information
Name
Aliasghar Darzi
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
a.darzi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of reaserch and Technology of Babol University of Medical Sciences
Expected recruitment start date
2013-05-26, 1392/03/05
Expected recruitment end date
2015-03-25, 1394/01/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of antibiotics on infectious complications after laparoscopic surgery for patients with Cholecystitis
Public title
Comparison of the efficacy of antibiotics on infectious complications after laparoscopic surgery for patients with Cholecystitis
Purpose
Supportive
Inclusion/Exclusion criteria
(Inclusion criteria: age less than 75 years; absence of immuned eficiency diseases; lack of endoscopic retrograde cholangiopancreatography in recent weeks; antibiotics a week before laparoscopy; no common bile duct stones; no diagnosis of acute cholecystitis with gallstones (based on clinical findings and clinical); diagnosis of pancreatitis and cholangitis; Exclusion criteria were: age over 75 years; the immune system is compromised; previous endoscopic retrograde cholangiopancreatography in recent weeks (due to antibiotics); antibiotics a week before laparoscopy; Common bile duct stones; acute cholecystitis with gallstones (based on clinical findings and clinical); pancreatitis and cholangitis; in cases where severe bleeding occurs during surgery or in the tear ducts bile and gallbladder due to needing antibiotics after surgery; all cases requiring surgical drains are in place)
Age
From 20 years old to 74 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences-Ganjafrooz Street-Babol-Iran
City
Babol
Postal code
Approval date
2013-05-14, 1392/02/24
Ethics committee reference number
2458
Health conditions studied
1
Description of health condition studied
Chronic cholecystitis
ICD-10 code
K81.1
ICD-10 code description
Chronic cholecystitis
Primary outcomes
1
Description
Surgical Site Infection
Timepoint
Five days after surgery
Method of measurement
Clinical
Secondary outcomes
1
Description
Respiratory Infection
Timepoint
24-72 hours after surgery
Method of measurement
Clinical
2
Description
Fever and Chills
Timepoint
24-72 hours after surgery
Method of measurement
Clinical
Intervention groups
1
Description
Intervention group cefazolin 25 mg / Kg intravenous before transfer to the operating room by the nurse and two doses every 6 hours after surgery, the patient is injected.
Category
Treatment - Surgery
2
Description
Regimen is not recommended for patients in the control group
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences
Full name of responsible person
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Reaserch and Technology of Babol University of Medical Sciences
Full name of responsible person
Dr Aliakbar Moghaddamnia
Street address
Babol University of Medical Sciences- Ganjafrooz Street-Babol-Iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Reaserch and Technology of Babol 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
Babol University of Medical Sciences
Full name of responsible person
Alieh Nikmanesh
Position
Student
Other areas of specialty/work
Street address
Babol University of Medical Sciences- Ganjafrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 1225 6285
Fax
Email
Hidekey-2@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Aliasghar Darzi
Position
General surgery
Other areas of specialty/work
Street address
Babol University of Medical Sciences-Ganj afrooz Street- Babol- Iran
City
Babol
Postal code
Phone
+98 11 1225 6285
Fax
Email
alidarzi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)