Viewing Study NCT05659303


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Study NCT ID: NCT05659303
Status: COMPLETED
Last Update Posted: 2024-04-18
First Post: 2022-12-13
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Organization:

Study Overview

Official Title: Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy
Status: COMPLETED
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HYSTECOE
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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: