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OpenTrials
Completed

NCT Number: NCT05659303

Evaluation of an Outpatient Protocol in Patients Operated for Laparoscopic Hysterectomy

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Clinique des Cèdres

Cornebarrieu, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic hysterectomy

Procedure

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

Primary outcomes

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

    Time frame: 1 day

    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

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: HYSTECOE

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2022
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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