Gynecologic CancerURINANCT05150262
Urinary Procedures Performed by Gynecologists, Results and Learning Curves.
An observational study of Gynecologic Cancer and Endometriosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Urinary procedures such as placing a JJ catheter, performing a psoic bladder, a Bricker technique or even a partial cystectomy are relatively frequent procedures in the context of the surgical management of gynecological cancer or endometriosis in order to obtain maximum reduction in oncology, or to overcome all… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Endometriosis
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2021to 30 Jul 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult woman with gynecological cancer or endometriosis, having undergone surgery between 01/01/2010 and 04/30/2021 at Strasbourg University Hospital
Who may be able to join
- Adult woman (≥18 years old)
- Woman with gynecological cancer or endometriosis, having undergone surgery between 01/01/2010 and 04/30/2021 at Strasbourg University Hospital
- With the performance of urological procedures during the operation performed by a surgical team composed of a gynecological surgeon
- Woman who did not express her opposition to the reuse of her data for the purposes of this research.
Who cannot join
- Woman who expressed her opposition to participating in the study
- Surgery performed by a team of surgeons not composed exclusively of gynecologists
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site, 1 recruiting
- Recruiting
Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Lise LECOINTRE, MD, 33 3 88 11 67 68, lise.lecointre@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Urinary procedures such as placing a JJ catheter, performing a psoic bladder, a Bricker technique or even a partial cystectomy are relatively frequent procedures in the context of the surgical management of gynecological cancer or endometriosis in order to obtain maximum reduction in oncology, or to overcome all endometriotic lesions when they affect the urinary tract. However, gynecological surgeons are not always trained in these specific procedures, the learning of which is crucial in the optimal management of these patients.
The aim of the research is to describe the surgical experience in terms of urinary actions (JJ catheter placement, psoic bladder, Bricker technique, cystectomy) over the past 10 years and determine a learning curve for a surgical team made up of only gynecological surgeons
- Conditions
- Gynecologic Cancer, Endometriosis
- Keywords
- Gynecologic Cancer, Endometriosis
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the surgical experience in terms of urinary procedures (JJ catheter placement, psoic bladder, Bricker's technique, cystectomy) over the past 10 years
Measured: Files analysed retrospectively from January 01, 2010 to April 30, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Nov 2021
- Primary completionJul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise LECOINTRE, MD, Principal investigator, Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150262
- Sponsor's protocol ID
- 8417
- Acronym
- URINA
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Procedures Performed by Gynecologists, Results and Learning Curves.
- ClinicalTrials.gov ID
- NCT05150262
- Acronym / sponsor ID
- URINA / 8417
- Conditions
- Gynecologic Cancer, Endometriosis
- Keywords
- Gynecologic Cancer, Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 9 Dec 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.
Urinary procedures such as placing a JJ catheter, performing a psoic bladder, a Bricker technique or even a partial cystectomy are relatively frequent procedures in the context of the surgical management of gynecological cancer or endometriosis in order to obtain maximum reduction in oncology, or to overcome all endometriotic lesions when they affect the urinary tract. However, gynecological surgeons are not always trained in these specific procedures, the learning of which is crucial in the optimal management of these patients.
The aim of the research is to describe the surgical experience in terms of urinary actions (JJ catheter placement, psoic bladder, Bricker technique, cystectomy) over the past 10 years and determine a learning curve for a surgical team made up of only gynecological surgeons
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult woman with gynecological cancer or endometriosis, having undergone surgery between 01/01/2010 and 04/30/2021 at Strasbourg University Hospital
Key inclusion criteria (4 listed)
- Adult woman (≥18 years old)
- Woman with gynecological cancer or endometriosis, having undergone surgery between 01/01/2010 and 04/30/2021 at Strasbourg University Hospital
- With the performance of urological procedures during the operation performed by a surgical team composed of a gynecological surgeon
- Woman who did not express her opposition to the reuse of her data for the purposes of this research.
Key exclusion criteria (2 listed)
- Woman who expressed her opposition to participating in the study
- Surgery performed by a team of surgeons not composed exclusively of gynecologists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe the surgical experience in terms of urinary procedures (JJ catheter placement, psoic bladder, Bricker's technique, cystectomy) over the past 10 years
Time frame: Files analysed retrospectively from January 01, 2010 to April 30, 2021 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
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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.
Saïd CHAYER, PhD, HDR contact
Lise LECOINTRE, MD principal investigator
Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
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 Gynecologic Cancer and Endometriosis, run by University Hospital, Strasbourg, France at 1 site in France.
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 4 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 9 Dec 2021. 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 France. 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?
Contact Lise LECOINTRE, MD (33 3 88 11 67 68, lise.lecointre@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the surgical experience in terms of urinary procedures (JJ catheter placement, psoic bladder, Bricker's technique, cystectomy) over the past 10 years (time frame: Files analysed retrospectively from January 01, 2010 to April 30, 2021 will be examined]). 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 9 Dec 2021.