Hysterectomy, VaginalvNOTESHCNCT05884658
Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy
A study testing vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomies and laparoscopic hysterectomy in people with Hysterectomy, Vaginal, run by Centre Hospitalier Universitaire de Saint Etienne at 6 sites in France.
Trial summary
In France, there are approximately 62,000 hysterectomies per year, 70% of which are benign. It is the most frequent surgical procedure in gynecology. Hysterectomies are performed via 3 routes: laparotomy, laparoscopy or vaginal route. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy, Vaginal
- What is being tested?
- vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomies and laparoscopic hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesFrance
- Study dates
- 23 Dec 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any woman received in preoperative consultation in the Gynecology-Obstetrics Department for a benign pathology of a uterus estimated to be large requiring a hysterectomy.
- Patient affiliated or entitled to a social security system
- Patients over 18 years of age
- Patients having given their agreement to participate and after signing the consent form
Who cannot join
- Woman refusing to participate in the study (lack of consent)
- Non-French speaking woman (unable to conduct a good quality interview of the pregnant woman)
- Participation in another interventional study.
- Patient subject to a legal protection measure or unable to express her consent
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
HFME - Hospices Civils de Lyon
Bron, 69677
Géry LAMBLIN, gery.lamlin@chu-lyon.fr
Géry LAMBLIN
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Sandrine CAMPAGNE-LOISEAU, PH, scampagne-loiseau@chu-clermontferrand.fr
Sandrine CAMPAGNE-LOISEAU, PH
- Not yet recruiting
Ch Issoire
Issoire, 63500
Aslam MANSOOR, amansoor@ch-issoire.fr
Aslam MANSOOR, PH
- Not yet recruiting
CHU LIMOGES - Hôpital de la mère et de l'Enfant
Limoges, 87042
Tristan GAUTHIER, PhD, (0)5 55 05 61 64 ext. +33, tristan.gauthier@chu-limoges.fr
- Not yet recruiting
CHU Saint-Etienne
Saint-Etienne, 42055
Céline CHAULEUR, PhD, 0477828383, celine.chauleur@chu-st-etienne.fr
Thomas CORSINI
- Not yet recruiting
Clinique Mutualiste de Saint-Etienne
Saint-Etienne, 42100
Quentin REBOUL, MD, quentinreboul@free.fr
Quentin REBOUL, MD
About this study
Official title: vNOTEsHC: Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy: a Randomized Controlled Trial
In France, there are approximately 62,000 hysterectomies per year, 70% of which are benign. It is the most frequent surgical procedure in gynecology.
Hysterectomies are performed via 3 routes: laparotomy, laparoscopy or vaginal route.
Read more
This choice of approach is particularly important in the case of large uteri (50% of uteri > 280g), which increase the risks of laparoconversion and bladder injury (NP3).
The vaginal route reduces the operating time and postoperative pain. Laparoscopy allows a better anatomical view and easier access to the neighbouring organs, which makes it the preferred approach, especially for young surgeons and when the uterus is large. However, the laparoscopic route is associated with an increase in the rate of conversion to laparotomy according to the volume of the uterus, as well as the rate of general per and postoperative complications compared with vaginal hysterectomy for uteri > 280 g. In a meta-analysis comparing laparoscopy and vaginal hysterectomy, the total prevalence of perioperative complications according to the classification of Clavien and Dindo was 27%. For large uteruses, complications by the vaginal route amounted to 15% and those by the laparoscopic route to 37.5%.
The data are not sufficient to give preference to one or other of the approaches, but for benign pathologies, for large uteri (>280 g), the minimally invasive laparoscopic or vaginal approaches are recommended by the CNGOF (grade C).
A new Medical Device (MD), the vNOTES (Vaginal Natural Orifice Transluminal Endoscopy System) offers the advantage of two approaches for pelvic surgery by allowing minimally invasive surgery to be performed by endoscopy through the vagina, offering perfect vision for the assistants and the operator and without scarring. Two randomized trials have shown that vNOTES allows, compared to laparoscopy, to perform adnexectomies and hysterectomies without conversion with less pain, fewer postoperative complications and a shorter hospitalization time.
The first evaluations of vNOTES are encouraging and suggest a new era for pelvic surgery: less postoperative pain, fewer complications and facilitation of ambulatory care. Also the videoscopic assistance of the vNOTES is a pedagogical tool for the vaginal route because the field of vision is no longer limited to the operator alone. However, the vNOTES has only been evaluated by the developers of the tool, in monocentric studies and in small numbers. The hysterectomy study evaluated only 35 patients with vNOTES, half of whom had a uterus of less than 280 g. The benefit of vNOTES for uteri smaller than 280 g is not obvious because of the ease of the surgical procedure and the cost of the "classic" vaginal route. Our study would be the first multicentric and academic study on vNOTES to focus specifically on large volume uteri, the most difficult to operate and prone to postoperative complications.
- Conditions
- Hysterectomy, Vaginal
- Being tested
- vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomies, laparoscopic hysterectomy
- Keywords
- natural orifice transluminal endoscopy system, large uteri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomiesProcedure or surgery
hysterectomy via the vaginal approach by vNOTES (natural vaginal orifice transluminal endoscopic system for hysterectomies)
laparoscopic hysterectomyProcedure or surgery
laparoscopic hysterectomy uses a standardized procedure with or without surgical robot
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic hysterectomy | Active comparator | Laparoscopic Hysterectomy will be performed in a standardized manner with or without surgical robot Receives: Procedure: laparoscopic hysterectomy |
| natural vaginal orifice transluminal endoscopic system for hysterectomies (vNOTES) | Experimental | Vaginal hysterectomy will be performed in a standardized manner using transluminal endoscopic system Receives: Procedure: vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patient with complications
The proportion of patients with at least one pre- and post-operative complication at 6 weeks will be estimated along with its 95% confidence interval in each surgical strategy group.
The primary endpoint is a composite endpoint including the occurrence of intraoperative and postoperative complications within 6 weeks of surgery.
Postoperative complications were Infectious complications, Bleeding complications and All hospital readmissions related to the procedure Postoperative complications will be classified according to the Clavien-Dindo classification
Intraoperative complications will be defined as :
- wounds of nearby organs (bladder, ureters, rectum, colon, small intestine)
- and bleeding defined as bleeding requiring immediate resumption, intraoperative transfusion and/or decreasing the patient's hemoglobin by more than 2 points compared to the last known preoperative blood sample
Measured: From surgery to 6 weeks of surgery
Secondary outcomes (1)
Conversion
Number of patients with conversion during surgery
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start23 Dec 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysterectomy, VaginalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, multicenter, randomized, parallel-group, non-inferiority open superiority study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Céline CHAULEUR, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884658
- Sponsor's protocol ID
- 21PH265
- Other IDs
- 2023-A01013-42
- Acronym
- vNOTESHC
- Status last verified
- Sep 2026
- First submitted
- 4 May 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- vNOTEsHC: Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery Versus or Laparoscopic Hysterectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05884658
- Acronym / sponsor ID
- vNOTESHC / 21PH265
- Conditions
- Hysterectomy, Vaginal
- Keywords
- natural orifice transluminal endoscopy system, large uteri
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Jun 2023 (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.
In France, there are approximately 62,000 hysterectomies per year, 70% of which are benign. It is the most frequent surgical procedure in gynecology.
Hysterectomies are performed via 3 routes: laparotomy, laparoscopy or vaginal route.
This choice of approach is particularly important in the case of large uteri (50% of uteri > 280g), which increase the risks of laparoconversion and bladder injury (NP3).
The vaginal route reduces the operating time and postoperative pain. Laparoscopy allows a better anatomical view and easier access to the neighbouring organs, which makes it the preferred approach, especially for young surgeons and when the uterus is large. However, the laparoscopic route is associated with an increase in the rate of conversion to laparotomy according to the volume of the uterus, as well as the rate of general per and postoperative complications compared with vaginal hysterectomy for uteri > 280 g. In a meta-analysis comparing laparoscopy and vaginal hysterectomy, the total prevalence of perioperative complications according to the classification of Clavien and Dindo was 27%. For large uteruses, complications by the vaginal route amounted to 15% and those by the laparoscopic route to 37.5%.
The data are not sufficient to give preference to one or other of the approaches, but for benign pathologies, for large uteri (>280 g), the minimally invasive laparoscopic or vaginal approaches are recommended by the CNGOF (grade C).
A new Medical Device (MD), the vNOTES (Vaginal Natural Orifice Transluminal Endoscopy System) offers the advantage of two approaches for pelvic surgery by allowing minimally invasive surgery to be performed by endoscopy through the vagina, offering perfect vision for the assistants and the operator and without scarring. Two randomized trials have shown that vNOTES allows, compared to laparoscopy, to perform adnexectomies and hysterectomies without conversion with less pain, fewer postoperative complications and a shorter hospitalization time.
The first evaluations of vNOTES are encouraging and suggest a new era for pelvic surgery: less postoperative pain, fewer complications and facilitation of ambulatory care. Also the videoscopic assistance of the vNOTES is a pedagogical tool for the vaginal route because the field of vision is no longer limited to the operator alone. However, the vNOTES has only been evaluated by the developers of the tool, in monocentric studies and in small numbers. The hysterectomy study evaluated only 35 patients with vNOTES, half of whom had a uterus of less than 280 g. The benefit of vNOTES for uteri smaller than 280 g is not obvious because of the ease of the surgical procedure and the cost of the "classic" vaginal route. Our study would be the first multicentric and academic study on vNOTES to focus specifically on large volume uteri, the most difficult to operate and prone to postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, multicenter, randomized, parallel-group, non-inferiority open superiority study
| Arm | Type | Receives |
|---|---|---|
| laparoscopic hysterectomy | Active comparator | Procedure: laparoscopic hysterectomyLaparoscopic Hysterectomy will be performed in a standardized manner with or without surgical robot |
| natural vaginal orifice transluminal endoscopic system for hysterectomies (vNOTES) | Experimental | Procedure: vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomiesVaginal hysterectomy will be performed in a standardized manner using transluminal endoscopic system |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any woman received in preoperative consultation in the Gynecology-Obstetrics Department for a benign pathology of a uterus estimated to be large requiring a hysterectomy.
- Patient affiliated or entitled to a social security system
- Patients over 18 years of age
- Patients having given their agreement to participate and after signing the consent form
Key exclusion criteria (4 listed)
- Woman refusing to participate in the study (lack of consent)
- Non-French speaking woman (unable to conduct a good quality interview of the pregnant woman)
- Participation in another interventional study.
- Patient subject to a legal protection measure or unable to express her consent
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 |
|---|---|---|
| vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomieshysterectomy via the vaginal approach by vNOTES (natural vaginal orifice transluminal endoscopic system for hysterectomies) | Procedure or surgery | natural vaginal orifice transluminal endoscopic system for hysterectomies (vNOTES) |
| laparoscopic hysterectomylaparoscopic hysterectomy uses a standardized procedure with or without surgical robot | Procedure or surgery | laparoscopic hysterectomy |
Primary outcome
Proportion of patient with complications
Time frame: From surgery to 6 weeks of surgery
The proportion of patients with at least one pre- and post-operative complication at 6 weeks will be estimated along with its 95% confidence interval in each surgical strategy group. The primary endpoint is a composite endpoint including the occurrence of intraoperative and postoperative complications within 6 weeks of surgery. Postoperative complications were Infectious complications, Bleeding complications and All hospital readmissions related to the procedure Postoperative complications will be classified according to the Clavien-Dindo classification Intraoperative complications will be defined as : * wounds of nearby organs (bladder, ureters, rectum, colon, small intestine) * and bleeding defined as bleeding requiring immediate resumption, intraoperative transfusion and/or decreasing the patient's hemoglobin by more than 2 points compared to the last known preoperative blood sample
1 secondary outcome
Conversion
Time frame: During surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Céline CHAULEUR, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vNOTES : natural vaginal orifice transluminal endoscopic system for hysterectomies and laparoscopic hysterectomy in people with Hysterectomy, Vaginal, run by Centre Hospitalier Universitaire de Saint Etienne at 6 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline CHAULEUR, PhD (0477828383 ext. +33, celine.chauleur@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patient with complications (time frame: From surgery to 6 weeks of 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 30 Sep 2026.