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Infection rate after cholecystectomy

Infections after laparoscopic and open cholecystectomy; Ceftriaxone versus placebo; a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138805012220N1
Enrollment
130
Registered
2009-11-01
Start date
2006-08-11
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: symptomatic gallstones. Condition 2: polyps of gallbladder. Cholelithiasis Other diseases of gallbladder

Interventions

Intervention 1: single dose of ceftriaxone, 1 gr. during induction of anesthesia. Intervention 2: single dose of normal saline ,10 cc during induction of anesthesia. Intervention 3: laparoscopic chole
Prevention
Placebo
Treatment - Surgery
single dose of ceftriaxone, 1 gr. during induction of anesthesia
single dose of normal saline ,10 cc during induction of anesthesia
laparoscopic cholecystectomy

Sponsors

Vice-Chancellor for Research,Shahid Beheshti University of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Complications of surgery method. Timepoint: during and one weak after surgery. Method of measurement: history and physical exam.;Spillage of bile/gallstone. Timepoint: during surgery. Method of measurement: observation.;Need for Subhepatic drain. Timepoint: within one weak after surgery. Method of measurement: cc of secretion.;Mean operation time. Timepoint: period between begining and end of surgery. Method of measurement: minute.;Bile culture results. Timepoint: one week after surgery. Method of measurement: culture results ,colony formation.;Surgical site infection. Timepoint: within one weak after surgery. Method of measurement: history,physical exam.;Hospital Stay. Timepoint: period between admition for surgery and discharge. Method of measurement: days.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamad Reza Sobhiyeh

Shahid Beheshti University of Medical Sciences

mreza_sobhiyeh@yahoo.com+98 21227180009

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026