NCT05659303

Brief Summary

Removal of the uterus, or hysterectomy, is a surgical operation that involves partial or total removal of the uterus. It can be done by vaginally, laparoscopically or laparotomically. Since the first hysterectomy performed by laparoscopy in 1989, this approach has gained popularity to varying degrees depending on the countries. This technique allows a major surgical procedure to be performed by incisions of only a few millimeters, thus reducing parietal pain and visceral in addition to a cosmetic benefit. Since 2013, more than 200 laparoscopic hysterectomies have been scheduled on an outpatient basis at the Clinique des Cèdres (France). The analysis of this retrospective series of approximately 200 patients would provide elements related to the practice of laparoscopic hysterectomy in ambulatory in France.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2023

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

December 13, 2022

Last Update Submit

April 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of performance, on an outpatient basis, of the laparoscopic hysterectomy procedure

    Success rate of performance, on an outpatient basis, of the laparoscopic hysterectomy procedure, on all laparoscopic hysterectomies scheduled on an outpatient basis since 2013 at the Clinique des Cèdres

    1 day

Study Arms (1)

Laparoscopic hysterectomy

Patient having undergone a hysterectomy, planned as an outpatient during the pre-operative consultation, by laparoscopic route.

Procedure: Laparoscopic hysterectomy

Interventions

Patient having undergone a hysterectomy, planned as an outpatient during the pre-operative consultation, by laparoscopic route.

Laparoscopic hysterectomy

Eligibility Criteria

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

Female aged 18 or over having undergone a hysterectomy, planned as an outpatient during the pre-operative consultation, by laparoscopic route with or without adnexectomy, for benign or malignant reasons, at the Clinique des Cèdres since 2013.

You may qualify if:

  • Female aged 18 or over.
  • Patient having undergone a hysterectomy, planned as an outpatient during the pre-operative consultation, by laparoscopic route with or without adnexectomy, for benign or malignant reasons, at the Clinique des Cèdres since 2013.
  • Patient having been informed of the research and not objecting to the use of his data as part of this research

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique des Cèdres

Cornebarrieu, France

Location

Study Design

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

Study Record Dates

First Submitted

December 13, 2022

First Posted

December 21, 2022

Study Start

October 15, 2022

Primary Completion

July 17, 2023

Study Completion

July 17, 2023

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations