Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy

Hysterotomy Clinical Trial

— H-vNOTES  

Official title:

Retrospective Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05150275
• Other study ID #: 8418
• Status: Not yet recruiting
• Start date: December 2021
• Est. completion date: December 2022

Study information

• Verified date: November 2021
• Source: University Hospital, Strasbourg, France
• Contact: Olivier GARBIN, MD
• Phone: 33 3 69 55 34 04
• Email: olivier.garbin[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysterotomy

Locations

Country	Name	City	State
France	Service de chirurgie gynécologique - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]