Antibiotic Prophylaxis in Laparoscopic Cholecystectomy

Cholelithiasis Clinical Trial

Official title:

Ciprofloxacin, Ampicillin-sulbactam and Placebo Prophylaxis in Laparoscopic Cholecystectomy. A Randomized Controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01888822
• Other study ID #: MarPic63
• Status: Terminated
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: June 2017

Study information

• Verified date: March 2020
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The trial aims to assess the value of two-regimen antibiotic prophylaxis versus placebo in elective laparoscopic cholecystectomy.

Description:

All patients enrolled will be submitted to laparoscopic cholecystectomy. The primary aim of the trial will be to assess the role of prophylactic i.v. infusion of ampicillin-sulbactam, ciprofloxacin, and placebo to reduce the rate of surgical site infection.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 138
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• elective laparoscopic cholecystectomy;

• patients suffering from gallbladder stones,chronic cholecystitis, cholesterolosis, or gallbladder polyps.

Exclusion Criteria:

• acute cholecystitis;

• acute cholangitis;

• acute pancreatitis;

• pregnant or lactating women;

• antibiotic allergy;

• antibiotic therapy within 48 hours to 7 days prior to surgery;

• clinically active infection at the moment of surgery;

• evidence of common bile duct stones;

• contraindications for laparoscopic cholecystectomy;

• no other additional procedure;

• indication of obligatory antibiotic prophylaxis because the medical condition was different from biliary disease (immunosuppression, corticoid use, etc).

• patients unable to give informed consent.

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Drug:
• Ciprofloxacin
Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy
• Ampicillin-sulbactam
Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy
• Placebo
Prophylactic placebo infusion before elective laparoscopic cholecystectomy

Locations

Country	Name	City	State
Italy	Sapienza University of Rome- Polo Pontino	Terracina	Latina

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Sanabria A, Dominguez LC, Valdivieso E, Gomez G. Antibiotic prophylaxis for patients undergoing elective laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD005265. doi: 10.1002/14651858.CD005265.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Surgical site infection defined according to the Centre of Disease Control (CDC) classification, recorded as 'yes' or 'no'.	30 days after operation
Secondary	Extra-abdominal infections	Extra-abdominal infections defined according to the CDC classification, recorded as 'yes' or 'no'.	30 days
Secondary	Adverse events.	Adverse events, defined as allergic reactions to antibiotics.	30 days
Secondary	Quality of life	Quality of life measured with the 36-Item Short Form Health Survey	30 days