Surgery; Maternal, Uterus or Pelvic Organs, Affecting FetusAMETHYSTNCT03290339
Feasibility of Ambulatory Hysterectomy
An observational study of Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus
- What is being tested?
- hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2017to 6 Dec 2019
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women more than 18 and Under 70 years old who undergo hysterectomy by laparoscopy or vaginal procedure in one the two units
Who may be able to join
- women, undergo surgery for hysterectomy by laparoscopy or vaginal procedure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Caen university hospital
Caen, Calvados, 14033
fabien Chaillot, +33 2 31 06 57 74, chaillot-f@chu-caen.fr
About this study
Official title: 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.
- Being tested
- hysterectomy
- Keywords
- one-day surgery, hysterectomy, ambulatory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysterectomyProcedure or surgery
laparoscopic hysterectomy and vaginal hysterectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
PADSS score
Measured: Day 0 post surgery
Secondary outcomes (1)
patient satisfaction
questionnaire
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start6 Sep 2017
- Primary completion6 Sep 2019 (estimated)
- Study completion6 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery; Maternal, Uterus or Pelvic Organs, Affecting FetusStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Amiens University Hospital
- Responsible party
- Principal investigator, Raffaele FAUVET, University Hospital, Caen
- Investigators
- raffaele Fauvet, MD, PhD, Principal investigator, Caen UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290339
- Sponsor's protocol ID
- 2017-A01505-48
- Acronym
- AMETHYST
- Status last verified
- Oct 2017
- First submitted
- 18 Sep 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study About the Feasibility of Ambulatory Hysterectomy: Bicentric Study in Caen UH and Amiens UH
- ClinicalTrials.gov ID
- NCT03290339
- Acronym / sponsor ID
- AMETHYST / 2017-A01505-48
- Keywords
- one-day surgery, hysterectomy, ambulatory
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Amiens University Hospital
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 6 Sep 2019 (estimated)
- Study completion
- 6 Dec 2019 (estimated)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women more than 18 and Under 70 years old who undergo hysterectomy by laparoscopy or vaginal procedure in one the two units
Key inclusion criteria (1 listed)
- women, undergo surgery for hysterectomy by laparoscopy or vaginal procedure
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hysterectomylaparoscopic hysterectomy and vaginal hysterectomy | Procedure or surgery | – |
Primary outcome
PADSS score
Time frame: Day 0 post surgery
1 secondary outcome
patient satisfaction
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
raffaele Fauvet, MD, PhD principal investigator
Caen UH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabien CHAILLOT (+33 2 31 06 57 74, chaillot-f@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PADSS score (time frame: Day 0 post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.