NCT02619149

Brief Summary

The benefit from antibiotic prophylaxis in patients undergoing laparoscopic cholecystectomy for acute cholecystitis is insufficiently known. The aim of the present double-blind randomized controlled is to compare piperacilin with placebo in patients undergoing cholecystectomy for acute cholecystitis with anamnesis not exceeding 5 days. Altogether 100 patients are intended to be included. Primary endpoint is biliary contamination. Secondary endpoints are postoperative hospital stay, health-related quality of life, pain perception, postoperative markers of inflammatory response, surgical site infections, infectious complications other than surgical site infections, health economy and relationship between symptom anamnesis and bile contamination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2009

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

8.8 years

First QC Date

November 26, 2015

Last Update Submit

March 5, 2018

Conditions

Cholecystitis, Acute

Outcome Measures

Primary Outcomes (1)

  • Proportion of positive bacterial cultures

    Proportion of patients with bacterial growth in the bile, assessed by culture from the bile assembled perioperatively.

    5 days

Secondary Outcomes (6)

  • Postoperative hospital stay

    5-10 days

  • Health-related quality of life

    One month

  • Postoperative pain as measured by the McGill Pain Questionnaire

    3 days

  • Levels of C-reactive Protein postoperatively

    3 days

  • Surgical site infections

    5-10 days

  • +1 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Piperacillin-tazobactam combination product

Drug: Piperacillin-tazobactam combination product

Control

PLACEBO COMPARATOR

Saline solution

Drug: Saline solution

Interventions

Piperacillin-tazobactam combination productDRUG

Piperacillin-Tazobactam (extended-spectrum, beta-lactamase inhibitor) iv peroperatively as prophylaxis

Also known as: Piperacillin-Tazobactam
Intervention
Saline solutionDRUG

Saline iv as placebo control

Control

Eligibility Criteria

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

You may qualify if:

  • Clinical and radiologic signs of acute cholecystitis
  • First acute symptoms occurring within five days before surgery

You may not qualify if:

  • Anamnesis exceeding five days
  • Any contraindication for laparoscopic surgery
  • Allergy against beta-lactame antibiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Center for Digestive Diseases

Stockholm, 14186, Sweden

Location

Related Publications (1)

  • Jaafar G, Sandblom G, Lundell L, Hammarqvist F. Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial. Langenbecks Arch Surg. 2020 Dec;405(8):1201-1207. doi: 10.1007/s00423-020-01977-x. Epub 2020 Aug 29.

    PMID: 32860109DERIVED

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Piperacillin, Tazobactam Drug CombinationSaline Solution

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

TazobactamPenicillanic AcidPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsCrystalloid SolutionsIsotonic SolutionsSolutions

Study Officials

  • Folke Hammarqvist, Ass Prof

    Karolinska Institutet, CLINTEC, Stockholm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 26, 2015

First Posted

December 2, 2015

Study Start

March 1, 2009

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

SE(1)