NCT03290339

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

September 18, 2017

Last Update Submit

October 10, 2017

Conditions

Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus

Keywords

one-day surgeryhysterectomyambulatory

Outcome Measures

Primary Outcomes (1)

  • PADSS score

    Day 0 post surgery

Secondary Outcomes (1)

  • patient satisfaction

    Day 1

Interventions

hysterectomyPROCEDURE

laparoscopic hysterectomy and vaginal hysterectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen university hospital

Caen, Calvados, 14033, France

RECRUITING

MeSH Terms

Interventions

Hysterectomy

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • raffaele Fauvet, MD, PhD

    Caen UH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabien CHAILLOT

CONTACT

+33 2 31 06 57 74chaillot-f@chu-caen.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 18, 2017

First Posted

September 21, 2017

Study Start

September 6, 2017

Primary Completion

September 6, 2019

Study Completion

December 6, 2019

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)