UrolithiasisNCT05293262
Endourological Management of Stones During COVID19
An observational study of Urolithiasis and COVID-19, run by Roxanne Teo at 1 site in Singapore.
Trial summary
Guidelines for endourological procedures during COVID-19 have suggested deferring all elective procedures, while obstructed/ infected stones should undergo urgent decompression. At our centre, screening protocols were implemented with prioritization strategies so that elective care could safely continue at deescalated… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Urolithiasis, COVID-19
- What is being tested?
- Endourological surgery
- Type of treatment
- Surgery or procedure
- How many people
- 158 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Jan 2020to 31 Aug 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with obstructing urolithiasis who underwent decompression of ureteric stents, ureteroscopy or retrograde intrarenal surgery with laser lithotripsy during the period of study in our institution were included in the study
Who may be able to join
- all patient with urolithiasis who underwent endourological interventions during COVID19 pandemic
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Definitive Endourological Interventions for Urolithiasis Management During COVID19- Outcomes From a Cohort Study
Guidelines for endourological procedures during COVID-19 have suggested deferring all elective procedures, while obstructed/ infected stones should undergo urgent decompression.
At our centre, screening protocols were implemented with prioritization strategies so that elective care could safely continue at deescalated rates. COVID or septic patients underwent emergency decompression, while non-COVID and non-septic patients underwent primary ureteroscopy (URS) or retrograde intrarenal surgery (RIRS).
We aim to report our experience with endourological surgery for stone disease during COVID-19.
Read the detailed description
We conducted a retrospective review of a prospectively maintained database of all endourological surgeries for stones in our centre during the first wave of COVID19.
- Conditions
- Urolithiasis, COVID-19
- Being tested
- Endourological surgery
- Keywords
- endourology, pandemic
- Medical subject headings
- Urolithiasis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endourological surgeryProcedure or surgery
Includes ureteral stent insertion, ureteroscopies and retrograde intrarenal surgeies
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent endourological surgery for urolithiasis during COVID19 | Endourological surgery (including ureteral stent insertion, ureteroscopy, retrograde intrarenal surgery) Receives: Procedure: Endourological surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Length of hospital stay
Measured: From admission to discharge from hospital, up to 3 months
Complication rate
Complications as defined by Clavien Dindo classification system
Measured: From admission up to 3 months post operatively
Stone free rate
Measured: At follow up visit in clinic 3 months post procedure
Secondary outcomes (1)
Readmission rate
Measured: From discharge up to three months post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start23 Jan 2020
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roxanne Teo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roxanne Teo, National University Health System, Singapore
- Investigators
- Chin Tiong Heng, Principal investigator, Ng Teng Fong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293262
- Sponsor's protocol ID
- 2020/01298
- Status last verified
- Mar 2022
- First submitted
- 13 Mar 2022
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definitive Endourological Interventions for Urolithiasis Management During COVID19- Outcomes From a Cohort Study
- ClinicalTrials.gov ID
- NCT05293262
- Acronym / sponsor ID
- 2020/01298
- Conditions
- Urolithiasis, COVID-19
- Keywords
- endourology, pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Roxanne TeoUniversity, hospital or other
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 24 Mar 2022 (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.
Guidelines for endourological procedures during COVID-19 have suggested deferring all elective procedures, while obstructed/ infected stones should undergo urgent decompression.
At our centre, screening protocols were implemented with prioritization strategies so that elective care could safely continue at deescalated rates. COVID or septic patients underwent emergency decompression, while non-COVID and non-septic patients underwent primary ureteroscopy (URS) or retrograde intrarenal surgery (RIRS).
We aim to report our experience with endourological surgery for stone disease during COVID-19.
Detailed description
We conducted a retrospective review of a prospectively maintained database of all endourological surgeries for stones in our centre during the first wave of COVID19.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent endourological surgery for urolithiasis during COVID19 | – | Procedure: Endourological surgeryEndourological surgery (including ureteral stent insertion, ureteroscopy, retrograde intrarenal surgery) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with obstructing urolithiasis who underwent decompression of ureteric stents, ureteroscopy or retrograde intrarenal surgery with laser lithotripsy during the period of study in our institution were included in the study
Key inclusion criteria (1 listed)
- all patient with urolithiasis who underwent endourological interventions during COVID19 pandemic
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Endourological surgeryIncludes ureteral stent insertion, ureteroscopies and retrograde intrarenal surgeies | Procedure or surgery | Patients who underwent endourological surgery for urolithiasis during COVID19 |
Primary outcome
Length of hospital stay
Time frame: From admission to discharge from hospital, up to 3 months
Length of hospital stay
Complication rate
Time frame: From admission up to 3 months post operatively
Complications as defined by Clavien Dindo classification system
Stone free rate
Time frame: At follow up visit in clinic 3 months post procedure
1 secondary outcome
Readmission rate
Time frame: From discharge up to three months post operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Chin Tiong Heng principal investigator
Ng Teng Fong General Hospital
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 Urolithiasis and COVID-19, run by Roxanne Teo at 1 site in Singapore.
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 0 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: finished, as of the sponsor's last update on 24 Mar 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 Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of hospital stay (time frame: From admission to discharge from hospital, up to 3 months). The study lists 3 primary outcomes in all. 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 24 Mar 2022.