HysterotomyH-vNOTESNCT05150275
Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy
An observational study of Hysterotomy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
vNOTES is a new surgical approach that has been used for less than 10 years. Several studies compare it to laparoscopy but none compare it to the classic vaginal route. The aim of the research is to analyze postoperative pain Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterotomy
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2021to Dec 2022
- 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 years and older
- Women only
- Adult, Older adult
Study population: Adult woman having undergone a vaginal hysterectomy and by vNOTES at Strasbourg University Hospitals between 01/01/2017 and 05/31/2021
Who may be able to join
- Adult woman (≥18 years old)
- Woman having undergone a vaginal hysterectomy and by vNOTES at Strasbourg University Hospitals between 01/01/2017 and 05/31/2021
- Woman who did not express her opposition to the reuse of her data for the purposes of this research.
Who cannot join
- Woman who expressed her opposition to participating in the study
- Surgical procedure associated with hysterectomy
Trial locations and contacts
1 site in 1 country.
Saïd CHAYER, PhD, HDR contact
France1 site
Service de chirurgie gynécologique - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Olivier GARBIN, MD, 33 3 69 55 34 04, olivier.garbin@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR, said.chayer@chru-strasbourg.fr
About this study
Official title: Retrospective Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy
vNOTES is a new surgical approach that has been used for less than 10 years. Several studies compare it to laparoscopy but none compare it to the classic vaginal route.
The aim of the research is to analyze postoperative pain
- Conditions
- Hysterotomy
- Keywords
- Hysterotomy, vNOTES, Laparoscopy, Vaginal route
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of postoperative pain in patients who have had a vaginal hysterectomy
Measured: Files analysed retrospectively from January 01, 2017 to May 31, 2021 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HysterotomyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier GARBIN, MD, Principal investigator, Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150275
- Sponsor's protocol ID
- 8418
- Acronym
- H-vNOTES
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy
- ClinicalTrials.gov ID
- NCT05150275
- Acronym / sponsor ID
- H-vNOTES / 8418
- Conditions
- Hysterotomy
- Keywords
- Hysterotomy, vNOTES, Laparoscopy, Vaginal route
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 9 Dec 2021 (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.
vNOTES is a new surgical approach that has been used for less than 10 years. Several studies compare it to laparoscopy but none compare it to the classic vaginal route.
The aim of the research is to analyze postoperative pain
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Adult woman having undergone a vaginal hysterectomy and by vNOTES at Strasbourg University Hospitals between 01/01/2017 and 05/31/2021
Key inclusion criteria (3 listed)
- Adult woman (≥18 years old)
- Woman having undergone a vaginal hysterectomy and by vNOTES at Strasbourg University Hospitals between 01/01/2017 and 05/31/2021
- Woman who did not express her opposition to the reuse of her data for the purposes of this research.
Key exclusion criteria (2 listed)
- Woman who expressed her opposition to participating in the study
- Surgical procedure associated with hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analysis of postoperative pain in patients who have had a vaginal hysterectomy
Time frame: Files analysed retrospectively from January 01, 2017 to May 31, 2021 will be examined]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
Related trials for Hysterotomy
RecruitingPhase 3
Effect of Preventive Analgesia by Injection of a Local Anesthetic Before Vaginal Incision for Hysterectomy by vNOTES Approach
Hysterotomy; Affecting Fetus
Not yet recruiting
Exteriorization Versus In Situ Hysterotomy Repair During Cesarean: Effects on Uterine Tone
Postpartum Hemorrhage, Uterine Atony
Recruiting
High vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean
Placenta Accreta Spectrum
Recruiting
Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)
Caesarean Scar Niche
Recruiting
Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
Cesarean Section; Dehiscence, Uterine Bleeding
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.
Saïd CHAYER, PhD, HDR contact
Olivier GARBIN, MD principal investigator
Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg
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 Hysterotomy, run by University Hospital, Strasbourg, France 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 3 inclusion and 2 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 9 Dec 2021. 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 Olivier GARBIN, MD (33 3 69 55 34 04, olivier.garbin@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of postoperative pain in patients who have had a vaginal hysterectomy (time frame: Files analysed retrospectively from January 01, 2017 to May 31, 2021 will be examined]). 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 9 Dec 2021.