Protocol for CAMUS Delphi Study

• Conditions: Complications; Urogenital, Postprocedural
• Interventions: Other: Comprehensive questionnaire

• Registration Number: NCT04976946
• Lead Sponsor: Melbourne Health

Brief Summary

Multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology.

Detailed Description

The CAMUS Delphi Study: A Consensus on Reporting of Complications After Urological Surgeries is a multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology. The initial survey consists of a 12-part questionnaire that will aim to reach consensus on a wide range of contentious issues in Urological surgery using the frameworks of both the established Clavien-Dindo Classification (CDC) and the new CAMUS Classification.

To ensure comprehensive and comparable complication reporting across centres worldwide, a conclusive uniform language for reporting complications must be created and subsequently integrated. Accurate reporting will allow for more precise allocation of resources, improve unit efficiency, and reduce healthcare burden, while providing clinicians with a better understanding of intra- and post-operative morbidity. If a comprehensive, homogenous reporting construct is integrated worldwide, the potential to build and develop a universal database with complications from all centres around the world will surely provide invaluable data to create new guidelines and recommendations, ultimately improving patient counselling and surgical quality of care.

Study Timeline

• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-26
• Study Start: 2021-08-12
• Primary Completion: 2022-08-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-17
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Local and international consultant Urologists, accredited Urology trainees, consultant Anaesthetists and consultant ICU specialists will be invited to complete the survey. Critical care physicians who are primarily Urological anaesthetists or have experience in complication reporting will be targeted.

Exclusion Criteria

• All other specialists that do not meet the inclusion criteria.
• Under 18 years of age.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anaesthetists	Comprehensive questionnaire	Local and international consultant anaesthetists. Critical care physicians who are primarily Urological anaesthetists or have experience in complication reporting will be targeted.
Urologists	Comprehensive questionnaire	Local and international consultant Urologists and accredited Urology trainees.
ICU specialists	Comprehensive questionnaire	Local and international consultant ICU specialists. Critical care physicians who are primarily Urological focused or have experience in complication reporting will be targeted.

Primary Outcome Measures

Name	Time	Method
Standardised complication reporting in Urology	6 months	Establish criteria for standardised complication reporting in Urology

Trial Locations

Locations (1)

The Royal Melbourne Hospital; 🇦🇺 Melbourne, Australia