Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy (H-vNOTES)

November 25, 2021 updated by: University Hospital, Strasbourg, France

Retrospective Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy

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

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de chirurgie gynécologique - Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Olivier GARBIN, MD
        • Sub-Investigator:
          • Tamara DE ROZARIO, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-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

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • Woman who expressed her opposition to participating in the study
  • Surgical procedure associated with hysterectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of postoperative pain in patients who have had a vaginal hysterectomy
Time Frame: Files analysed retrospectively from January 01, 2017 to May 31, 2021 will be examined]
Files analysed retrospectively from January 01, 2017 to May 31, 2021 will be examined]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Olivier GARBIN, MD, Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 8418 (Other Identifier: CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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