Feasibility of Ambulatory Hysterectomy (AMETHYST)

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: Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus
• Intervention / Treatment: Procedure: hysterectomy

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: fabien Chaillot; Phone Number: +33 2 31 06 57 74; Email: chaillot-f@chu-caen.fr

Study Locations

• France
  • Calvados
    • Caen, Calvados, France, 14033
      • Recruiting
      • CAEN university Hospital
      • Contact: fabien Chaillot; Phone Number: +33 2 31 06 57 74; Email: chaillot-f@chu-caen.fr

Participation Criteria

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

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	Day 0 post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction	questionnaire	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Amiens University Hospital
• Investigators: Principal Investigator: raffaele Fauvet, MD, PhD, Caen UH

Study record dates

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: hysterectomy; one-day surgery; ambulatory
• 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