Protocol for CAMUS Delphi Study

October 14, 2022 updated by: Melbourne Health

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • The Royal Melbourne Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 6 months
Establish criteria for standardised complication reporting in Urology
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melbourne Health

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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