the role of prophylactic antibiotics in wound infection in selective laparoscopic cholecystectomy
Design
This study is a double-blind clinical trial with case-control, and randomized control grouped.
Settings and conduct
Patients with uncomplicated gallbladder stone who come to the Bahonar or Afzalipour Hospital of Kerman, in specified time who are candidates for laparoscopic cholecystectomy. These patients will be randomly divided into B and A groups. Group A patients received cefazolin antibiotics (dose of 1 gram) and group B received 10 cc isotonic normal saline, half an hour before surgery and two postoperative doses of 6 hours will be given intravenously. They Will be checked 24 hours after surgery, and 4 to 7, 10, 15 and 30 days after surgery for wound infection.
Participants/Inclusion and exclusion criteria
Entry criteria: Age less than 75 years; No Immune deficiency disease; No history of Endoscopic Retrograde Cholangiography; Pancreatitis in the last week; Absence of antibiotics in one week prior to laparoscopy;No Common bile ducts stone; Non-detection of acute cholecystitis with gallstone stone; Lack of recognition of pancreatitis and cholangitis;
Exit criteria: Age over 75 years; Impairment of immune system; history of Endoscopic Retrograde Cholangiography; Pancreatitis in the last week; Antibiotic use in one week before laparoscopy; Common bile duct stone; Diagnosis of acute cholecystitis with gallstone; Diagnosis of pancreatitis and cholangitis; In cases of severe bleeding; Or cases of bile duct and gallbladder rupture due to the need for post-operative antibiotics; All cases requiring a drane in the surgical site
Intervention groups
In the case group, prophylactic antibiotics were administered and in the control group placebo were Interventions
Main outcome variables
Surgical site infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180615040107N1
Registration date:2019-02-07, 1397/11/18
Registration timing:retrospective
Last update:2019-02-07, 1397/11/18
Update count:0
Registration date
2019-02-07, 1397/11/18
Registrant information
Name
Amir Behzadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3439 2049
Email address
a.behzadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2018-07-22, 1397/04/31
Trial completion date
2018-08-22, 1397/05/31
Scientific title
The role of prophylactic antibiotics on surgical site infections in elective laparoscopic cholecystectomy in patients with symptomatic gallstone.
Public title
prophylactic antibiotics on surgical site infections in elective laparoscopic cholecystectomy.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with symptomatic gallstone
Patients candidate for elective laparoscopic cholecystectomy
Patient under 75 years old
Exclusion criteria:
Patients who received antibiotics in the few days before surgery
Patients with CBD stone or cholecystitis
Patients with a history of diabetes
Patients with using drugs that affect the immune system
Age
To 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
76
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
By simple randomization in this study, these patients were randomly assigned to two groups A and B with random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating in the study, the principal researcher, physicians and nurses, data analyzers and outcome evaluators, were unaware of the allocation of each patient to the placebo group instead of antibiotics.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.KMU.REC.1397.082
Health conditions studied
1
Description of health condition studied
Surgical site infection
ICD-10 code
T81.4
ICD-10 code description
Infection following a procedure, not elsewhere classified
Primary outcomes
1
Description
Surgical site infection involves redness and swelling of the wound or purulent discharge
Timepoint
24 hours after surgery and 4 to 7, 10 to 15 and 30 days after surgery
Method of measurement
Clinical
Secondary outcomes
1
Description
Respiratory infection
Timepoint
24 to 72 hours after surgery
Method of measurement
Clinical
2
Description
Fever& chills
Timepoint
24 to 72 hours after surgery
Method of measurement
Clinical
Intervention groups
1
Description
Intervention group: In the first group, an antibiotic, cefazolin (one dose of 1 gram), will receive intravenous half an hour before the operation and two doses (1 gram) after surgery for 6 hours.
Category
Treatment - Surgery
2
Description
Control group: In the second group, 10 cc of Isotonic normal saline will be given intravenously half an hour before surgery and two doses after surgery for a period of 6 hours.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar hospital
Full name of responsible person
Bahram Poorseyedi
Street address
Shahid Bahonar hospital, Qaraney St.
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarhospital@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abass Pardakhti
Street address
Kerman, Ibn Sina Avenue, Somayeh Route, Research and Technology Department
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
vcr@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/vcrt
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Determining the frequency of post-operative infection by age, determining the frequency of post-operative infection by sex, determining the frequency of post-operative infection based on the history of smoking. The total potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia and Scientific institutions
Under which criteria data/document could be used
For academic and medical research
From where data/document is obtainable
Amir Behzadi, Email: amirbehzady.ab@gmail.com
What processes are involved for a request to access data/document
With sending the submitted proposal, I will send data within a month