Protocol for CAMUS Delphi Study

Protocol for CAMUS Delphi Study: A Consensus on Reporting of Complications After Urological Surgeries

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Complications; Urogenital, Postprocedural
• Intervention / Treatment: Other: Comprehensive questionnaire

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 Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

Study Locations

• Australia
  • Melbourne, Australia
    • The Royal Melbourne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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. Must be over the age of 18 years.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Urologists; Local and international consultant Urologists and accredited Urology trainees.	Other: Comprehensive questionnaire; Multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology.
Anaesthetists; Local and international consultant anaesthetists. Critical care physicians who are primarily Urological anaesthetists or have experience in complication reporting will be targeted.	Other: Comprehensive questionnaire; Multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology.
ICU specialists; Local and international consultant ICU specialists. Critical care physicians who are primarily Urological focused or have experience in complication reporting will be targeted.	Other: Comprehensive questionnaire; Multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardised complication reporting in Urology	Establish criteria for standardised complication reporting in Urology	6 months

Collaborators and Investigators

• Sponsor: Melbourne Health
• Investigators: Principal Investigator: Marc A Furrer, MD, Melbourne Health

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2021
• Primary Completion (Actual): August 14, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2020.046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No