Minimally Invasive SurgeryVANOLAHNCT05971875
RCT on 3 Types of Hysterectomy
A study testing vNOTES vs Vaginal Hysterectomy and vNOTES vs Laparoscopic Hysterectomy in people with Minimally Invasive Surgery, run by Dr Jan Baekelandt, MD at 2 sites in 2 countries.
Trial summary
A randomized controlled trial comparing the vaginal, vNOTES ( vaginal natural orifice transluminal surgery) or laparoscopic approach for hysterectomy in women with benign gynaecological disease Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Minimally Invasive Surgery
- What is being tested?
- vNOTES vs Vaginal Hysterectomy and vNOTES vs Laparoscopic Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2024to 1 Jan 2026
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy
Who cannot join
- Women with a stage II+ prolapse in need of a hysterectomy as part of vaginal prolapse repair
- hysterectomy due to suspected endometriosis
- subtotal hysterectomy
- history of rectal surgery
- suspected malignancy
- suspected obliteration of the pouch of Douglas following severe PID or other causes
Show all 10Show fewer
- active lower genital tract infection
- pregnancy
- failure to provide written informed consent prior to surgery
- requirement of in-patient care due to other co-morbidities
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Croatia1 site, 1 recruiting
- Recruiting
Dept of Obstetrics and Gynecology
Zadar
Luka Matak
Sweden1 site, 1 recruiting
- Recruiting
Dept of Obstetrics and Gynecology
Helsingborg, 25438
Andrea Stuart, phD
About this study
Official title: A Multinational Randomized Controlled Trial Including Two Identical Sub Studies Comparing Vaginal Versus vNOTES (Vaginal Natural Orifice Transluminal Surgery) Hysterectomy or Laparoscopic Versus vNOTES Hysterectomy.
A randomized controlled trial comparing the vaginal, vNOTES ( vaginal natural orifice transluminal surgery) or laparoscopic approach for hysterectomy in women with benign gynaecological disease
Read the detailed description
Multi-center pragmatic non-blinded RCT including 1000 women 18-75 years in need of hysterectomy for benign disease; comparing VH vs vNOTES or LH vs vNOTES.
- Conditions
- Minimally Invasive Surgery
- Being tested
- vNOTES vs Vaginal Hysterectomy, vNOTES vs Laparoscopic Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vNOTES vs Vaginal HysterectomyProcedure or surgery
Comparison of vNOTES vs VH
vNOTES vs Laparoscopic HysterectomyProcedure or surgery
Comparison of vNOTES vs LH
| Study group | Role | What they receive |
|---|---|---|
| vNOTES vs Vaginal Hysterectomy | Active comparator | Group A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES Receives: Procedure: vNOTES vs Vaginal Hysterectomy |
| vNOTES vs Laparoscopic Hysterectomy | Active comparator | If VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES Receives: Procedure: vNOTES vs Laparoscopic Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of women leaving the hospital within 12 hours after surgery complications.
Day sugery
Measured: 12 hours
Secondary outcomes (7)
Hospitalization time
Time admitted
Measured: 6 weeks
conversion rates
conversion to different surgival technique
Measured: 12 hours
duration of the surgical procedure
from placement of Foley to last stich
Measured: 12 hours
Intraoperative complications.
Complication
Measured: 12 hours
postoperative complications,
Clavien Dindo
Measured: 6 weeks
re-admission requiring hospitalization
Readminssion
Measured: 6 weeks
Patient Reported Outcome Measures.
Short Female Sexual Function Index.
Measured: 3 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Minimally Invasive SurgeryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Jan Baekelandt, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Jan Baekelandt, MD, Imelda Hospital, Bonheiden
- Investigators
- JAn Baekelandt, Principal investigator, Imeldaziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971875
- Sponsor's protocol ID
- Vanolah
- Acronym
- VANOLAH
- Status last verified
- Mar 2024
- First submitted
- 7 Jul 2023
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lerner V, Ulrich A, Chen CCG, Baekalandt J. Vaginal Natural Orifice Transluminal Endoscopic Surgery in Minimally Invasive Gynecologic Surgery. Obstet Gynecol. 2026 Apr 1;147(4):e66-e90. doi: 10.1097/AOG.0000000000006198. Epub 2026 Mar 6.
PubMed 41785457Baekelandt JF, Stuart A, Wagenius J, Laenen A, Mol BW, Deprest J, Bosteels JJA. VaNoLaH trial: a study protocol-a multinational randomised controlled trial including two identical substudies comparing vaginal versus vNOTES (vaginal natural orifice transluminal surgery) hysterectomy or laparoscopic versus vNOTES hysterectomy. BMJ Open. 2024 Apr 23;14(4):e081979. doi: 10.1136/bmjopen-2023-081979.
PubMed 38658010
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational Randomized Controlled Trial Including Two Identical Sub Studies Comparing Vaginal Versus vNOTES (Vaginal Natural Orifice Transluminal Surgery) Hysterectomy or Laparoscopic Versus vNOTES Hysterectomy.
- ClinicalTrials.gov ID
- NCT05971875
- Acronym / sponsor ID
- VANOLAH / Vanolah
- Conditions
- Minimally Invasive Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dr Jan Baekelandt, MDUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 2 Aug 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.
A randomized controlled trial comparing the vaginal, vNOTES ( vaginal natural orifice transluminal surgery) or laparoscopic approach for hysterectomy in women with benign gynaecological disease
Detailed description
Multi-center pragmatic non-blinded RCT including 1000 women 18-75 years in need of hysterectomy for benign disease; comparing VH vs vNOTES or LH vs vNOTES.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vNOTES vs Vaginal Hysterectomy | Active comparator | Procedure: vNOTES vs Vaginal HysterectomyGroup A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES |
| vNOTES vs Laparoscopic Hysterectomy | Active comparator | Procedure: vNOTES vs Laparoscopic HysterectomyIf VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy
Key exclusion criteria (10 listed)
- Women with a stage II+ prolapse in need of a hysterectomy as part of vaginal prolapse repair
- hysterectomy due to suspected endometriosis
- subtotal hysterectomy
- history of rectal surgery
- suspected malignancy
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 vs Vaginal HysterectomyComparison of vNOTES vs VH | Procedure or surgery | vNOTES vs Vaginal Hysterectomy |
| vNOTES vs Laparoscopic HysterectomyComparison of vNOTES vs LH | Procedure or surgery | vNOTES vs Laparoscopic Hysterectomy |
Primary outcome
proportion of women leaving the hospital within 12 hours after surgery complications.
Time frame: 12 hours
Day sugery
7 secondary outcomes
Hospitalization time
Time frame: 6 weeks
conversion rates
Time frame: 12 hours
duration of the surgical procedure
Time frame: 12 hours
Intraoperative complications.
Time frame: 12 hours
postoperative complications,
Time frame: 6 weeks
re-admission requiring hospitalization
Time frame: 6 weeks
Patient Reported Outcome Measures.
Time frame: 3 months postop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 41785457Lerner V, Ulrich A, Chen CCG, Baekalandt J. Vaginal Natural Orifice Transluminal Endoscopic Surgery in Minimally Invasive Gynecologic Surgery. Obstet Gynecol. 2026 Apr 1;147(4):e66-e90. doi: 10.1097/AOG.0000000000006198. Epub 2026 Mar 6.
- Derived from this study: PubMed 38658010Baekelandt JF, Stuart A, Wagenius J, Laenen A, Mol BW, Deprest J, Bosteels JJA. VaNoLaH trial: a study protocol-a multinational randomised controlled trial including two identical substudies comparing vaginal versus vNOTES (vaginal natural orifice transluminal surgery) hysterectomy or laparoscopic versus vNOTES hysterectomy. BMJ Open. 2024 Apr 23;14(4):e081979. doi: 10.1136/bmjopen-2023-081979.
- 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. This study is not recruiting at the moment.
JAn Baekelandt principal investigator
Imeldaziekenhuis
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vNOTES vs Vaginal Hysterectomy and vNOTES vs Laparoscopic Hysterectomy in people with Minimally Invasive Surgery, run by Dr Jan Baekelandt, MD at 2 sites in 2 countries.
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 10 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 22 Mar 2024. 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 Croatia, Sweden. 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 Jan Baekelandt, Prof (0032499471371, jan.baekelandt@imelda.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of women leaving the hospital within 12 hours after surgery complications. (time frame: 12 hours). 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 NCT05971875, which also lists 2 linked publications.
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 22 Mar 2024.