CClinicalTrials.gg
Status unknownNCT03290339AMETHYSTUpdated Oct 11, 2017

Feasibility of Ambulatory Hysterectomy

An observational study in Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus, sponsored by University Hospital, Caen. Status unknown at 1 site in France. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-11.

Sponsored by University Hospital, Caen · Observational

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus

Keywords

  • one-day surgery
  • hysterectomy
  • ambulatory
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Interventions

  • Procedurehysterectomy

    laparoscopic hysterectomy and vaginal hysterectomy

05

What researchers measure

Primary outcomes

  1. PADSS score

    Time frame: Day 0 post surgery

Secondary outcomes

  1. patient satisfaction

    questionnaire

    Time frame: Day 1

06

Study locations

1 of 1 sites recruiting
  • Caen university hospital
    Caen, Calvados 14033, France
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03290339
Lead sponsor
University Hospital, Caen
Collaborators
Amiens University Hospital
Responsible party
Raffaele FAUVET (professor, University Hospital, Caen) — Principal investigator
First posted
Sep 21, 2017
Start date
Sep 6, 2017
Primary completion
Sep 6, 2019 (estimated)
Completion
Dec 6, 2019 (estimated)
Last update
Oct 11, 2017

Study contacts

Fabien CHAILLOT
Contact
chaillot-f@chu-caen.fr
+33 2 31 06 57 74
raffaele Fauvet, MD, PhD
principal investigator · Caen UH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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