Protocol summary

Study aim
Evaluation the effect of prophylactic administration of first-generation cephalosporin antibiotics in decreasing the rate of wound infection in laparoscopic cholecystectomy in patients admitted to the Velayat hospital since 2016 to 2018
Design
In a double blind, randomized clinical trial, all patients candidate laparoscopic cholecystectomy at Velayat hospital during 2015-2017 entered to study. Patients are placed randomly (closed packet) in two groups. Before study informed consent form are completed by patients. Inclusion criteria are age<60. Exclusion Criteria are consumption antibiotic in 7 days ago, cholecyst in 6 past month, history of allergy or drug interactions with cephalosporin. In intervention group, 25 mg/kg cefazolin in per intervenes injection before surgery and 2 dose per 8 hours after surgery are prescribed, and control group with not receiving drug. At 24 hours after surgery, with close up wound dressing, they will be discharged in the absence of problems of nutrition, motility and fever. The patient should refer to remove stitches up to two weeks with having unusual pain symptoms, fever and chills, nausea and vomiting. Infection symptoms of surgery site (pain, swelling and redness, retraction purulent leak from incision site) are reported as SSI based on surgeon diagnosis. Peritoneal infection or abscess of Surgery site, respiratory infections and urinal infection are reported as other infectious complication after confirming by surgeon. The visual analogous scale of the pain is assessed at 24, 48 and 72 hours after surgery. Factors of age, sex, history of underlying diseases such as diabetes, high blood pressure, high blood sugar, heart disease, history of smoking, are documented.
Settings and conduct
In a double blind, randomized clinical trial, all patients candidate laparoscopic cholecystectomy at Velayat hospital during 2015-2017 entered to study. Patients are placed randomly (closed packet) in two groups. Before study informed consent form are completed by patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients candidate laparoscopic cholecystectomy; age<60. Exclusion criteria: consumption antibiotic in 7 days ago, cholecyst in 6 past months, Evidence of colaenitis or obstructive jaundice and biliary pancreatitis; systematic Corticosteroid therapy; reduced kidney function and liver failure; history of allergy; disorder in PT and PTT; drug interactions with cephalosporin; Breast feeding or pregnancy; History of biliary tract surgery or endoscopic retrograded cholangiography previous.
Intervention groups
In intervention group, 25 mg/kg cefazolin in per intervenes injection before surgery and 2 dose per 8 hours after surgery are prescribed, and control group with not receiving drug.
Main outcome variables
The visual analogous scale of the pain is assessed at 24, 48 and 72 hours after surgery.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171126037629N1
Registration date: 2018-01-02, 1396/10/12
Registration timing: registered_while_recruiting

Last update: 2018-01-02, 1396/10/12
Update count: 0
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
davoud mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 5800
Email address
d.mohammadi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of prophylactic administration of first-generation cephalosporin antibiotics in decreasing of wound infection in patients candidates laparoscopic cholecystectomy
Public title
Evaluation the effect of prophylactic administration of antibiotics in decreasing of wound infection in patients candidates laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: patients candidate laparoscopic cholecystectomy; age<60.
Exclusion criteria:
Exclusion criteria: consumption antibiotic in 7 days ago cholecyst in 6 past months Evidence of colaenitis or obstructive jaundice and biliary pancreatitis systematic Corticosteroid therapy reduced kidney function and liver failure history of allergy disorder in PT and PTT drug interactions with cephalosporin Breast feeding or pregnancy History of biliary tract surgery or endoscopic retrograded cholangiography previous.
Age
To 60 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 268
More than 1 sample in each individual
Number of samples in each individual: 134
In intervention group, 25 mg/kg cefazolin in per intervenes injection before surgery and 2 dose per 8 hours after surgery are prescribed, and control group with not receiving drug.
Randomization (investigator's opinion)
Randomized
Randomization description
Study is done as randomized, double blind on the individual by closed packet.
Blinding (investigator's opinion)
Double blinded
Blinding description
Study is done as randomized, double blind (investigator and patients) by closed packet ( by assigning the letters A and B to the cards in the envelope and randomly selecting the envelopes by the patients). Before study informed consent form are completed by patients.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of Qazvin university of medical sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Approval date
2017-10-25, 1396/08/03
Ethics committee reference number
IR. QUMS.REC.1396.300

Health conditions studied

1

Description of health condition studied
gallbladder
ICD-10 code
K80.1
ICD-10 code description
Calculus of gallbladder with other cholecystitis

Primary outcomes

1

Description
Post operative pain
Timepoint
The pain is assessed at 24, 48 and 72 hours after surgery.
Method of measurement
The visual analogous scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 25 mg/kg cefazolin in per intervenes injection before surgery and 2 dose per 8 hours after surgery
Category
Treatment - Drugs

2

Description
Control group: Without drug regimen.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Reza Noori Moghadam
Street address
Taavon Blvd.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
rajresearch95@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Reza Noori Moghadam
Street address
Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
rajresearch95@gmail.com
Grant name
Vice chancellor for research, Qazvin University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
50
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
Qazvin University of Medical Sciences
Full name of responsible person
Reza Noori Moghadam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
rajresearch95@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Davood Mohammadi
Position
sub specialist thorax
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
rajresearch95@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Reza Noori Moghadam
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
rajresearch95@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
That is secret according to informed consent.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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