NCT01888822

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

3 years

First QC Date

June 13, 2013

Last Update Submit

March 24, 2020

Conditions

Cholelithiasis

Keywords

Laparoscopic cholecystectomyProphylactic antibiotics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Extra-abdominal infections

    30 days

  • Adverse events.

    30 days

  • Quality of life

    30 days

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Intravenous infusion of 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.

Drug: Placebo

Ampicillin-sulbactam

ACTIVE COMPARATOR

Intravenous infusion of 3gr ampicillin-sulbactam in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.

Drug: Ampicillin-sulbactam

Ciprofloxacin

ACTIVE COMPARATOR

Intravenous infusion of 400 mg ciprofloxacin in 0.9% Sodium Chloride 250 ml during induction of anesthesia and before laparoscopic cholecystectomy.

Drug: Ciprofloxacin

Interventions

CiprofloxacinDRUG

Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy

Ciprofloxacin
Ampicillin-sulbactamDRUG

Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy

Ampicillin-sulbactam
PlaceboDRUG

Prophylactic placebo infusion before elective laparoscopic cholecystectomy

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective laparoscopic cholecystectomy;
  • patients suffering from gallbladder stones,chronic cholecystitis, cholesterolosis, or gallbladder polyps.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sapienza University of Rome- Polo Pontino

Terracina, Latina, 04019, Italy

Location

Related 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;2010(12):CD005265. doi: 10.1002/14651858.CD005265.pub2.

    PMID: 21154360BACKGROUND

MeSH Terms

Conditions

Cholelithiasis

Interventions

Ciprofloxacinsultamicillin

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Erasmo Spaziani, MD, PhD

    University of Roma La Sapienza

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 28, 2013

Study Start

June 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2017

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

IT(1)