Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy

Hysterectomy Clinical Trial

— HYSTECOE  

Official title:

Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659303
• Other study ID #: GCS RAMSAY SANTE
• Status: Completed
• Start date: October 15, 2022
• Est. completion date: July 17, 2023

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 17, 2023
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysterectomy

Intervention

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

Locations

Country	Name	City	State
France	Clinique des Cèdres	Cornebarrieu

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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