Association of Cephalosporin Resistance and Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy

NCT ID: NCT05581017

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

376 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-16

Study Completion Date

2022-10-10

Brief Summary

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Preoperative biliary drainage predisposes the bile to be contaminated with bacteria of the duodenum. These bacteria colonizing the bile are a potential source for surgical site infections after pancreaticoduodenectomy and many international guidelines recommend the use of cephalosporines as microbial prophylaxis before surgery. The aim of this study was to assess the incidence of bacteria in bile, their resistance profiles and association to surgical site infections in relation to timing of surgery after preoperative biliary drainage in order to better guide antibiotic use.

Detailed Description

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Conditions

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Surgical Site Infection Pancreaticoduodenectomy Biliary Tract Infection Bacterial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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No PBD

Patients without preoperative biliary drainage before pancreaticoduodenectomy

No interventions assigned to this group

PBD < 2 months

Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was in 2 months after the drainage.

Preoperative biliary drainage

Intervention Type PROCEDURE

Preoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future.

PBD ≥ 2 months

Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was at 2 months or later after the drainage.

Preoperative biliary drainage

Intervention Type PROCEDURE

Preoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future.

Interventions

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Preoperative biliary drainage

Preoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing pancreaticoduodenectomy between May 23rd 2016 to October 29th 2020

Exclusion Criteria

* Patients without intraoperative biliary culture
* Patients with unknown date of preoperative biliary culture
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Timo Tarvainen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timo O Tarvainen, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterological Surgery, Helsinki University Hospital

Locations

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Helsinki Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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HUS-115-2020-56

Identifier Type: -

Identifier Source: org_study_id

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