NCT05150262

Brief 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 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

8 months

First QC Date

November 25, 2021

Last Update Submit

November 25, 2021

Conditions

Keywords

Gynecologic CancerEndometriosis

Outcome Measures

Primary Outcomes (1)

  • Describe the surgical experience in terms of urinary procedures (JJ catheter placement, psoic bladder, Bricker's technique, cystectomy) over the past 10 years

    Files analysed retrospectively from January 01, 2010 to April 30, 2021 will be examined]

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult woman with gynecological cancer or endometriosis, having undergone surgery between 01/01/2010 and 04/30/2021 at Strasbourg University Hospital

You may qualify if:

  • 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.

You may not qualify if:

  • Woman who expressed her opposition to participating in the study
  • Surgery performed by a team of surgeons not composed exclusively of gynecologists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Lise LECOINTRE, MD

    Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Saïd CHAYER, PhD, HDR

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 9, 2021

Study Start

November 1, 2021

Primary Completion

July 1, 2022

Study Completion

July 30, 2022

Last Updated

December 9, 2021

Record last verified: 2021-11

Locations