Protocol summary

Summary
Gall stone disease is one of the most frequent gastro-intestinal diseases ends up to surgery. Although laparoscopic cholecystectomy is accepted as treatment of choice in many countries worldwide, but its cost beneficiency and effectiveness in developing countries is controversial and is depended to multiple factors. Role of prophylactic antibiotics in prevention of infection is also controversial. In this study, we included 130 patients with cholelithiases with symptomatic acute /chronic cholecystitis or polyps of gall bladder admitted for surgery in Shohada E Tajrish Hospital between 2006 and 2008. They randomly were treated by either open or laparoscopic cholecystectomy. In each group, patients received cefteriaxon as prophylaxis of infection or isotonic sodium chlorides solution as placebo. In all patients, bile samples during surgery were collected and cultured. We compare patients according to demographic features, body weight ASA score, frequency of empyema, hydrops of gall bladder, cholecystitis, gall stones /polyps at time of admission, mean time of surgery and hospital stay, complications of surgery and infection rate. The aim of this study is to compare the role of surgery method and prophylactic antibiotic in reducing the complications (infection, rupture of gall bladder, spillage of bile /gallstone, need for subhepatic drains), and hospital stay period.

General information

Acronym
IRAC
IRCT registration information
IRCT registration number: IRCT138805012220N1
Registration date: 2009-11-01, 1388/08/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-11-01, 1388/08/10
Registrant information
Name
Mohamad Reza Sobhiyeh
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8001
Email address
mozafar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research,Shahid Beheshti University of Medical Science
Expected recruitment start date
2006-08-11, 1385/05/20
Expected recruitment end date
2008-08-11, 1387/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Infections after laparoscopic and open cholecystectomy; Ceftriaxone versus placebo; a randomized clinical trial
Public title
Infection rate after cholecystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1-aged 20-80, 2- cholelithiasis with acute/chronic cholecystitis [based on three of the following signs; abdominal pain in the upper right quadrant, Murphy’s sign, leucocytosis > 10000/mm³, rectal temperature > 38 °C or < 36.5 °C plus, cholecystolithiasis (stones/sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall) or polyps of gallbladder], 3- admitted in Shohada-e-Tajrish Hospital, Tehran, Iran for cholecystectomy between 2006 and 2008. Exclusion criteria: 1- Pregnant women, 2-patients with jaundice at the time of diagnosis, 3- coagulopathy, 4-coledocholithiasis, 5- portal hypertension, 6- diabetes mellitus, 7- immunosuppressive disorders, 8-previous biliary surgery, 9- biliary pancreatitis, 10- history of antibiotic consumption within one week before surgery, 11-allergic reaction/anaphylaxis to penicillin or cephalosporins, 12- any acute emergency interventions, 13- any contraindications for LC (previous history of abdominal surgery), 14 -conversion from LC to OC, 15- do not agree with conditions of study.
Age
From 20 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
After explanation of surgical methods and study protocol we divided the patients into two groups by a table of random numbers. Group A undergone open cholecystectomy (OC) and group B undergone Laparoscopic Cholecystectomy (LC). Lab tests (CBC/diff, AST, ALT, serum billirubin, ALK-Ph) were checked for all patients before surgery. All surgeries were performed with the same surgery team who were expert in both methods. In each group patients randomly divided into two subgroups: first group received 1 gram Ceftriaxone during induction of anesthesia and the second group received 10 ml of isotonic sodium chlorides solution as placebo.drugs are injected by Anesthesiologist and neither the surgery team,who follow the patients,nor the patient know about the type of drug recieved . None of the patients received extra dosage of antibiotics (AB) during/after surgery. We compare patients according to demographic features, body weight ASA score, frequency of empyema, hydrops of gall bladder, cholecystitis, gall stones /polyps at time of admission, mean time of surgery and hospital stay, complications of surgery and infection rate, in each surgery method and compare the role of prophylactic antibiotic in reducing infection rate.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Shahid Beheshti Blv. Daneshjoo Sqr. Velenjac
City
Tehran
Postal code
1985717443
Approval date
2007-06-04, 1386/03/14
Ethics committee reference number
125

Health conditions studied

1

Description of health condition studied
symptomatic gallstones
ICD-10 code
k80
ICD-10 code description
Cholelithiasis

2

Description of health condition studied
polyps of gallbladder
ICD-10 code
k82
ICD-10 code description
Other diseases of gallbladder

Primary outcomes

1

Description
complications of surgery method
Timepoint
during and one weak after surgery
Method of measurement
history and physical exam

2

Description
Spillage of bile/gallstone
Timepoint
during surgery
Method of measurement
observation

3

Description
need for Subhepatic drain
Timepoint
within one weak after surgery
Method of measurement
cc of secretion

4

Description
Mean operation time
Timepoint
period between begining and end of surgery
Method of measurement
minute

5

Description
bile culture results
Timepoint
one week after surgery
Method of measurement
culture results ,colony formation

6

Description
surgical site infection
Timepoint
within one weak after surgery
Method of measurement
history,physical exam

7

Description
Hospital Stay
Timepoint
period between admition for surgery and discharge
Method of measurement
days

Secondary outcomes

empty

Intervention groups

1

Description
single dose of ceftriaxone, 1 gr. during induction of anesthesia
Category
Prevention

2

Description
single dose of normal saline ,10 cc during induction of anesthesia
Category
Placebo

3

Description
laparoscopic cholecystectomy
Category
Treatment - Surgery

4

Description
open cholecystectomy
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Surgery, Shohada e Tajrish Hospital
Full name of responsible person
Mohamad Mozafar-Mohamad Reza Sobhiyeh, Farinaz Fattahi
Street address
Department of Surgery,Shohada e Tajrish Hospital,Tajrish Square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research,Shahid Beheshti University of Medical Science
Full name of responsible person
Dr.M.Rahmati Rudsari
Street address
Vice-Chancellor for Research,5th floor ,2nd block,Shahid Beheshti University of Medical Science,Velenjak,Tehran
City
Tehran
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,Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad Reza Sobhiyeh
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Department of Surgery, Shohada e Tajrish Hospital,Tajrish Square
City
Tehran
Postal code
1989934148
Phone
+98 21227180009
Fax
+98 21 2272 1144
Email
mreza_sobhiyeh@yahoo.com
Web page address
sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohamad Mozafar
Position
Associated Professor of Vascular Surgery and Trauma, Shahid Beheshti University of Medical Sciences
Other areas of specialty/work
Street address
Department of Surgery, Shohada e Tajrish Hospital,Tajrish Square
City
Tehran
Postal code
1989934148
Phone
+98 21227180009
Fax
+98 21 2272 1144
Email
mozafar@sbmu.ac.ir
Web page address
sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medcal Sciences
Full name of responsible person
Farinaz Fattahi
Position
MD.
Other areas of specialty/work
Street address
Cancer Research Center, Shohada e Tajrish Hospital,Tajrish Square
City
Tehran
Postal code
1989934148
Phone
+98 21227480012
Fax
+98 21227480012
Email
farinaz_fattahi@yahoo.com
Web page address
www.crc.ir

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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