Complications; Urogenital, PostproceduralNCT04976946
Protocol for CAMUS Delphi Study
An observational study of Complications; Urogenital, Postprocedural, run by Melbourne Health at 1 site in Australia.
Trial summary
Multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Complications; Urogenital, Postprocedural
- What is being tested?
- Comprehensive questionnaire
- How many people
- 750 participants
- Where
- 1 siteAustralia
- Study dates
- 12 Aug 2021to Dec 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- All other specialists that do not meet the inclusion criteria.
- Under 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Comprehensive questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive questionnaireOther
Multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology.
| Study group | Role | What they receive |
|---|---|---|
| Urologists | Local and international consultant Urologists and accredited Urology trainees. Receives: Other: Comprehensive questionnaire | |
| Anaesthetists | Local and international consultant anaesthetists. Critical care physicians who are primarily Urological anaesthetists or have experience in complication reporting will be targeted. Receives: Other: Comprehensive questionnaire | |
| 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. Receives: Other: Comprehensive questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardised complication reporting in Urology
Establish criteria for standardised complication reporting in Urology
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start12 Aug 2021
- Primary completion14 Aug 2022
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Urogenital, PostproceduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Melbourne Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc A Furrer, MD, Principal investigator, Melbourne Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976946
- Sponsor's protocol ID
- 2020.046
- Status last verified
- Oct 2022
- First submitted
- 15 Jul 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for CAMUS Delphi Study: A Consensus on Reporting of Complications After Urological Surgeries
- ClinicalTrials.gov ID
- NCT04976946
- Acronym / sponsor ID
- 2020.046
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Melbourne HealthUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Urologists | – | Other: Comprehensive questionnaireLocal and international consultant Urologists and accredited Urology trainees. |
| Anaesthetists | – | Other: Comprehensive questionnaireLocal and international consultant anaesthetists. Critical care physicians who are primarily Urological anaesthetists or have experience in complication reporting will be targeted. |
| ICU specialists | – | Other: Comprehensive questionnaireLocal and international consultant ICU specialists. Critical care physicians who are primarily Urological focused or have experience in complication reporting will be targeted. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- All other specialists that do not meet the inclusion criteria.
- Under 18 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive questionnaireMulti-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology. | Other | Anaesthetists, ICU specialists, Urologists |
Primary outcome
Standardised complication reporting in Urology
Time frame: 6 months
Establish criteria for standardised complication reporting in Urology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc A Furrer, MD principal investigator
Melbourne Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications; Urogenital, Postprocedural, run by Melbourne Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardised complication reporting in Urology (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.