Feasibility of Ambulatory Hysterectomy (AMETHYST)

October 10, 2017 updated by: Raffaele FAUVET, University Hospital, Caen

Preliminary Study About the Feasibility of Ambulatory Hysterectomy: Bicentric Study in Caen UH and Amiens UH

Hysterectomy is one of the most performed surgery in women. Public authorities wish that one-day surgery become a majority and hysterectomy could be part of it in the future. The aim of this study is to determine the feasibility of ambulatory hysterectomy.

Patients and methods: Investigators will realize an observational descriptive survey based on questionnaires in two surgical gynecology units. Women under 70 years old, who undergo hysterectomy will be included.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Calvados
      • Caen, Calvados, France, 14033
        • Recruiting
        • Caen University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women more than 18 and Under 70 years old who undergo hysterectomy by laparoscopy or vaginal procedure in one the two units

Description

Inclusion Criteria:

  • women, undergo surgery for hysterectomy by laparoscopy or vaginal procedure

Exclusion Criteria:

  • comorbidities included: heart disease, anti-coagulant treatment, anti-aggregant treatment; sleep apnea syndrome, laparotomy laparoconversion if hysterectomy associated with appendectomy and/or, omentectomy and/or, lymph nodes dissection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PADSS score
Time Frame: Day 0 post surgery
Day 0 post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction
Time Frame: Day 1
questionnaire
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

Amiens University Hospital

Investigators

  • Principal Investigator: raffaele Fauvet, MD, PhD, Caen UH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2017

Primary Completion (Anticipated)

September 6, 2019

Study Completion (Anticipated)

December 6, 2019

Study Registration Dates

First Submitted

September 18, 2017

First Submitted That Met QC Criteria

September 20, 2017

First Posted (Actual)

September 21, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 10, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-A01505-48

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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