Uterine FibroidsPRE v-NOTESNCT07895953
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
An observational study of Uterine Fibroids and Hysterectomy, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Uterine fibroids are the most common benign tumors in women of reproductive age and are a major indication for hysterectomy. This retrospective, single-center observational study aims to identify factors associated with the success or failure of vaginal natural orifice transluminal endoscopic surgery (v-NOTES)… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids, Hysterectomy, Vaginal Natural Orifice Transluminal Endoscopic Surgery (v-NOTES)
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2026to 20 Mar 2027
- Phase
- Observational
- 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
Study population: Adult women who underwent v-NOTES hysterectomy for a large or very large uterus at Strasbourg University Hospitals between January 1, 2024, and December 31, 2025, and who have not objected to the reuse of their medical data for scientific research. The estimated sample size is approximately 50 patients.
Who may be able to join
- Women aged 18 years or older.
- Patients who underwent v-NOTES hysterectomy for a large uterus at Strasbourg University Hospitals between January 1, 2024, and December 31, 2025. The uterine weight threshold for defining a large uterus remains to be determined (280 g or 500 g).
- Patients who have not objected to the reuse of their data for scientific research.
Who cannot join
- Patients who have objected to the reuse of their data for scientific research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie gynécologique - CMCO - Hôpitaux universitaires de Strasbourg - France
Strasbourg, 67091
Victor Gabriele, MD, 33 3 69 55 34 55, victor.gabriele@chru-strasbourg.fr
Victor Gabriele, MD
About this study
Uterine fibroids are the most common benign tumors in women of reproductive age and are a major indication for hysterectomy. This retrospective, single-center observational study aims to identify factors associated with the success or failure of vaginal natural orifice transluminal endoscopic surgery (v-NOTES) hysterectomy for large and very large uteri.
Approximately 50 adult women who underwent v-NOTES hysterectomy for a large uterus at Strasbourg University Hospitals between January 1, 2024, and December 31, 2025, will be included. Data will be extracted retrospectively from medical records. The primary outcome is successful completion of the v-NOTES procedure without conversion to another surgical approach. Potential predictive factors include body mass index, parity, uterine weight, fibroid location, adenomyosis, vaginal access, previous cesarean deliveries or pelvic surgery, and preoperative medical treatments intended to reduce uterine volume or inflammation.
Secondary outcomes include surgical complications, operative duration, length of hospital stay, and unplanned readmission within 30 days of surgery.
- Conditions
- Uterine Fibroids, Hysterectomy, Vaginal Natural Orifice Transluminal Endoscopic Surgery (v-NOTES)
- Keywords
- v-NOTES hysterectomy, Large uterus, Predictors of surgical success and conversion
- Medical subject headings
- Leiomyoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful completion of v-NOTES hysterectomy without conversion to another surgical approach
Proportion of v-NOTES hysterectomies for large and very large uteri completed without conversion to another surgical approach, based on the operative report. Potential predictors of success or conversion include body mass index, parity, uterine weight, FIGO fibroid location, adenomyosis, preoperative vaginal access assessment, previous cesarean delivery or pelvic surgery, and preoperative medical treatment intended to reduce uterine volume or inflammation.
Measured: During surgery, for procedures performed between January 1, 2024, and December 31, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start20 Mar 2026
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine FibroidsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895953
- Sponsor's protocol ID
- RC26_0096
- Acronym
- PRE v-NOTES
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
- ClinicalTrials.gov ID
- NCT07895953
- Acronym / sponsor ID
- PRE v-NOTES / RC26_0096
- Conditions
- Uterine Fibroids, Hysterectomy, Vaginal Natural Orifice Transluminal Endoscopic Surgery (v-NOTES)
- Keywords
- v-NOTES hysterectomy, Large uterus, Predictors of surgical success and conversion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
Uterine fibroids are the most common benign tumors in women of reproductive age and are a major indication for hysterectomy. This retrospective, single-center observational study aims to identify factors associated with the success or failure of vaginal natural orifice transluminal endoscopic surgery (v-NOTES) hysterectomy for large and very large uteri.
Approximately 50 adult women who underwent v-NOTES hysterectomy for a large uterus at Strasbourg University Hospitals between January 1, 2024, and December 31, 2025, will be included. Data will be extracted retrospectively from medical records. The primary outcome is successful completion of the v-NOTES procedure without conversion to another surgical approach. Potential predictive factors include body mass index, parity, uterine weight, fibroid location, adenomyosis, vaginal access, previous cesarean deliveries or pelvic surgery, and preoperative medical treatments intended to reduce uterine volume or inflammation.
Secondary outcomes include surgical complications, operative duration, length of hospital stay, and unplanned readmission within 30 days of surgery.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women who underwent v-NOTES hysterectomy for a large or very large uterus at Strasbourg University Hospitals between January 1, 2024, and December 31, 2025, and who have not objected to the reuse of their medical data for scientific research. The estimated sample size is approximately 50 patients.
Key inclusion criteria (3 listed)
- Women aged 18 years or older.
- Patients who underwent v-NOTES hysterectomy for a large uterus at Strasbourg University Hospitals between January 1, 2024, and December 31, 2025. The uterine weight threshold for defining a large uterus remains to be determined (280 g or 500 g).
- Patients who have not objected to the reuse of their data for scientific research.
Key exclusion criteria (1 listed)
- Patients who have objected to the reuse of their data for scientific research.
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
Successful completion of v-NOTES hysterectomy without conversion to another surgical approach
Time frame: During surgery, for procedures performed between January 1, 2024, and December 31, 2025
Proportion of v-NOTES hysterectomies for large and very large uteri completed without conversion to another surgical approach, based on the operative report. Potential predictors of success or conversion include body mass index, parity, uterine weight, FIGO fibroid location, adenomyosis, preoperative vaginal access assessment, previous cesarean delivery or pelvic surgery, and preoperative medical treatment intended to reduce uterine volume or inflammation.
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 26 Oct 2026.
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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.
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 Uterine Fibroids and Hysterectomy, 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 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
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 Victor Gabriele, MD (33 3 69 55 34 55, victor.gabriele@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful completion of v-NOTES hysterectomy without conversion to another surgical approach (time frame: During surgery, for procedures performed between January 1, 2024, and December 31, 2025). 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 26 Oct 2026.