HysterectomyVLAPNCT05031182
Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.
A study testing Laparoscopy and vNOTES in people with Hysterectomy and Laparoscopy, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy, Laparoscopy, vNOTES
- What is being tested?
- Laparoscopy and vNOTES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Oct 2021to 25 Feb 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult woman eligible for total hysterectomy for benign lesions with or without bilateral adnexectomy.
- Able to give informed consent to participate in research.
- Affiliation to a Social Security scheme.
Who cannot join
- Pregnant or breastfeeding women
- Contraindication to the laparoscopic approach
- Contraindication to first vNOTES, in particular: virginity, history of rectal surgery, rectovaginal endometriosis, high active genital infection
- Indications for another concomitant surgical procedure (other than procedure on the appendix)
- Indication of hysterectomy for malignant lesion.
- Any concomitant pathology deemed incompatible with the study.
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- COVID not cured or SARS-COv2 positivity dating less than 3 days before surgery.
- Adult patient protected, under guardianship or curatorship or legal safeguard
- Refusal of participation.
Trial locations and contacts
2 sites in 1 country.
About this study
During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.
- Conditions
- Hysterectomy, Laparoscopy, vNOTES
- Being tested
- Laparoscopy, vNOTES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
The hysterectomy is performed by laparoscopy as described in the EMC.
vNOTESProcedure or surgery
The hysterectomy is performed by vNOTES as described Dr BAEKELANDT and this team.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy | Placebo comparator | In this Arm, patient will have the traditional hysterectomy by laparoscopy. This is the type of surgery that we realize everyday. Receives: Procedure: Laparoscopy |
| vNOTES | Active comparator | In this Arm, patient will have the hysterectomy by vNOTES (vaginal natural orifices Transluminal surgery). It's the new type of surgery that we want prove the no-inferiority. Receives: Procedure: vNOTES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications per or post Operative
Appearance of a per or post operative complication: bleeding, digestive or urinary sore or infection
Measured: one month after surgery
Secondary outcomes (5)
Measure of pain
Quantification of postoperative pain: 6 hours, 24 hours, day 2, 5, 7, 14 and at one month
Measured: Until one month
Duration of operation
From skin opening to skin or vaginal closure
Measured: one day
Assessment of quality of life
Respond to SF-36 questionnaire to assess and compare quality of life before and after surgery
Measured: Six month
Assessment of satisfaction
Respond to FSFI questionnaire to assess and compare sexuality before and after surgery
Measured: Six month
Duration of work stoppage
Patients will inquire if they needed to prolong the sick leave.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start11 Oct 2021
- Primary completion25 Feb 2025
- Study completion25 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra CURINIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031182
- Sponsor's protocol ID
- RBHP 2021 CURINIER
- Other IDs
- 2021-A01218-33
- Acronym
- VLAP
- Status last verified
- Mar 2025
- First submitted
- 25 Aug 2021
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6.
PubMed 37642285
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.
- ClinicalTrials.gov ID
- NCT05031182
- Acronym / sponsor ID
- VLAP / RBHP 2021 CURINIER
- Conditions
- Hysterectomy, Laparoscopy, vNOTES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 25 Feb 2025 (actual)
- Study completion
- 25 Feb 2025 (actual)
- First posted
- 1 Sep 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.
During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy | Placebo comparator | Procedure: LaparoscopyIn this Arm, patient will have the traditional hysterectomy by laparoscopy. This is the type of surgery that we realize everyday. |
| vNOTES | Active comparator | Procedure: vNOTESIn this Arm, patient will have the hysterectomy by vNOTES (vaginal natural orifices Transluminal surgery). It's the new type of surgery that we want prove the no-inferiority. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult woman eligible for total hysterectomy for benign lesions with or without bilateral adnexectomy.
- Able to give informed consent to participate in research.
- Affiliation to a Social Security scheme.
Key exclusion criteria (9 listed)
- Pregnant or breastfeeding women
- Contraindication to the laparoscopic approach
- Contraindication to first vNOTES, in particular: virginity, history of rectal surgery, rectovaginal endometriosis, high active genital infection
- Indications for another concomitant surgical procedure (other than procedure on the appendix)
- Indication of hysterectomy for malignant lesion.
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 |
|---|---|---|
| LaparoscopyThe hysterectomy is performed by laparoscopy as described in the EMC. | Procedure or surgery | Laparoscopy |
| vNOTESThe hysterectomy is performed by vNOTES as described Dr BAEKELANDT and this team. | Procedure or surgery | vNOTES |
Primary outcome
Complications per or post Operative
Time frame: one month after surgery
Appearance of a per or post operative complication: bleeding, digestive or urinary sore or infection
5 secondary outcomes
Measure of pain
Time frame: Until one month
Duration of operation
Time frame: one day
Assessment of quality of life
Time frame: Six month
Assessment of satisfaction
Time frame: Six month
Duration of work stoppage
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Derived from this study: PubMed 37642285Pickett CM, Seeratan DD, Mol BWJ, Nieboer TE, Johnson N, Bonestroo T, Aarts JW. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD003677. doi: 10.1002/14651858.CD003677.pub6.
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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. This study is not recruiting at the moment.
Sandra CURINIER principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopy and vNOTES in people with Hysterectomy and Laparoscopy, run by University Hospital, Clermont-Ferrand at 2 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications per or post Operative (time frame: one month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05031182, which also lists 1 linked publication.
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 2 Feb 2026.