NCT05150275

Brief Summary

vNOTES is a new surgical approach that has been used for less than 10 years. Several studies compare it to laparoscopy but none compare it to the classic vaginal route. The aim of the research is to analyze postoperative pain

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 9, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

November 25, 2021

Last Update Submit

November 25, 2021

Conditions

Keywords

HysterotomyvNOTESLaparoscopyVaginal route

Outcome Measures

Primary Outcomes (1)

  • Analysis of postoperative pain in patients who have had a vaginal hysterectomy

    Files analysed retrospectively from January 01, 2017 to May 31, 2021 will be examined]

Eligibility Criteria

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

Adult woman having undergone a vaginal hysterectomy and by vNOTES at Strasbourg University Hospitals between 01/01/2017 and 05/31/2021

You may qualify if:

  • Adult woman (≥18 years old)
  • Woman having undergone a vaginal hysterectomy and by vNOTES at Strasbourg University Hospitals between 01/01/2017 and 05/31/2021
  • 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
  • Surgical procedure associated with hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de chirurgie gynécologique - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Study Officials

  • Olivier GARBIN, 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 CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 9, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 9, 2021

Record last verified: 2021-11

Locations