Optimized Perioperative Antibiotic Prophylaxis in Radical Cystectomy
PAPRAC
1 other identifier
interventional
196
1 country
2
Brief Summary
Cystectomy with urinary diversion (ileal conduit, orthotopic ileal bladder substitute, continent catheterizable pouch) is the best treatment option for patients with muscle-invasive bladder cancer. This intervention is one of the most challenging in urology and has a high rate of postoperative complications including around 30% of postoperative infections. Perioperative antibiotic prophylaxis (PAP) is widely accepted as a crucial preventive measure to reduce the incidence of surgical site infections (SSI). The rationale for PAP is the reduction of the local bacterial load at the site and time of intervention, and therefore a short duration of PAP of 24 to maximal 48 hours is recommended for all clean to clean-contaminated procedures.. Evidence supporting the optimal duration of PAP for radical cystectomy with urinary diversion is lacking. Based on data extrapolated from abdominal surgery, current guidelines recommend short-term PAP (≤24h) for all clean-contaminated procedures including radical cystectomy. However, a recent evaluation revealed a significant inter-hospital variability of PAP and showed that extended use (\>48h) was common in patients undergoing radical cystectomy. Importantly, this study also demonstrated that longer duration of PAP incurred higher costs and was associated with an increased rate of C. difficile colitis. A small, prospective, non-randomized study showed equal efficacy of short-term PAP in preventing postoperative infections in patients undergoing radical cystectomy with ileum conduit compared to extended PAP. Nonetheless, larger randomized clinical trials supporting these findings are lacking. The unwarranted extended use of antibiotics is a major concern as exposure to antibiotics is a driving force for the development of (multi-) resistant bacteria and will lead to an increasing number of difficult-to-treat infections. This has been recognized on both national and international levels and is addressed within antimicrobial stewardship frameworks. This study will compare current practice (\>48h PAP, "extended PAP") with the guideline recommended approach (24h PAP, "short term PAP") in a single-centre, prospective, randomised clinical non-inferiority trial. The primary outcome is the rate of SSI within 90 days post surgery. The aim of the study is to generate currently lacking evidence allowing for an optimised PAP strategy in a challenging surgical setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
September 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 10, 2017
CompletedStudy Start
First participant enrolled
April 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedMay 8, 2024
May 1, 2024
5.9 years
September 27, 2017
May 7, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
Rate of Surgical Site infections (SSI)
Rate of surgical site infections occurring within 90 days post surgery will be calculated for each patient.
90 days
Time to event of SSI
Time to event of SSI (event free survival analysis)
90 days
Rate of Urinary tract infections (UTI)
Rate of urinary tract infections occurring within 90 days post surgery will be calculated for each patient.
90 days
Time to event of UTI
Time to event of UTI (event free survival analysis)
90 days
Secondary Outcomes (4)
Rate and type of Antibiotic associated adverse events (AEs)
30 days
Frequency of multi-drug-resistant bacteria in urinary samples
30 days
Changes in fecal flora
30 days
Antibiotic associated costs
30 days
Study Arms (2)
Short PAP
EXPERIMENTALPerioperative antibiotic prophylaxis will be stopped after 24h
Extended PAP
ACTIVE COMPARATORPerioperative antibiotic prophylaxes will be continued for 48h or more (until all indwelling urinary catheters have been removed)
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent
- Age \>18 years
- Planned radical cystectomy at the Department of Urology, Bern University Hospital
You may not qualify if:
- Contraindications to the classes of drugs under study, e.g. known hypersensitivity or allergy to class of drugs including alternatives described in the protocol or the investigational product,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Infectious Diseases, University Hospital Bern
Bern, 3010, Switzerland
Department of Urology, University Hopspital Bern
Bern, 3010, Switzerland
Related Publications (1)
Thurnheer MC, Schurmann A, Huber M, Marschall J, Wuethrich PY, Burkhard FC. Perioperative Antibiotic Prophylaxis Duration in Patients Undergoing Cystectomy With Urinary Diversion: A Randomized Clinical Trial. JAMA Netw Open. 2024 Oct 1;7(10):e2439382. doi: 10.1001/jamanetworkopen.2024.39382.
PMID: 39422911DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria C Thurnheer, MD
Department of Infectious Diseases, University Hospital Bern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2017
First Posted
October 10, 2017
Study Start
April 9, 2018
Primary Completion
February 28, 2024
Study Completion
February 28, 2024
Last Updated
May 8, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share