Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy (HYSTECOE)

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy
• Intervention / Treatment: Procedure: Laparoscopic hysterectomy

Detailed Description

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 (Reich, 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. Thus, when we offer women requiring a two-way hysterectomy first, 84% of them prefer the laparoscopic route to the laparotomy route (Nieboer, 2009). Alongside this surgical advance, an improvement in anesthesy techniques combined with the use of anti-inflammatories and antiemetics made it possible to improve the speed of recovery and therefore the possibility of a departure early, but not premature, from the hospital. In the United States, a study published in 2012 (Schiavone, 2012) reported the hospital stays of more than 128,000 women who underwent a laparoscopic total hysterectomy and reported that 46% of them had been operated on as an outpatient.

Since 2013, more than 200 laparoscopic hysterectomies have been scheduled on an outpatient basis at the Clinique des Cèdres.

The analysis of this retrospective series of approximately 200 patients would provide elements related to the practice of laparoscopic hysterectomy in ambulatory in France.

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• France
  • Cornebarrieu, France
    • Clinique des Cèdres

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic hysterectomy; Patient having undergone a hysterectomy, planned as an outpatient during the pre-operative consultation, by laparoscopic route.	Procedure: Laparoscopic hysterectomy; Patient having undergone a hysterectomy, planned as an outpatient during the pre-operative consultation, by laparoscopic route.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): July 17, 2023

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: GCS RAMSAY SANTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No