Ovarian CystsADNOLANCT06964594
A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy
A study testing vNOTES adnexal surgery in people with Ovarian Cysts and Laparoscopic Gynecologic Surgery, run by Region Skane.
Trial summary
The aim with the study is to compare postoperative pain after vNOTES adnexal surgery versus laparoscopic adnexal surgery. Women aged 18 and above with an indication for adnexal surgery for benign gynecological pathology or prophylactic reasons will be able to participate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cysts, Laparoscopic Gynecologic Surgery, vNOTES
- What is being tested?
- vNOTES adnexal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to Dec 2028
- 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
- Participant is willing and able to give informed consent for participation in the trial.
- Female aged 18 years or above.
- Diagnosed with adnexal pathology or subject for prophylactic BSO.
Who cannot join
- Female participant who is pregnant or planning pregnancy during course of the trial.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Patients taking opioids or other painkillers routinely pre-operatively.
- Patients with chronic pelvic pain.
- Patients with surgical contraindication; previous hysterectomy, history of rectal surgery, suspected or confirmed endometriosis, suspected malignancy, suspected obliteration of the pouch of Douglas following severe PID or other causes, active lower genital tract infection, pregnancy.
- Failure to provide written informed consent prior to surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim with the study is to compare postoperative pain after vNOTES adnexal surgery versus laparoscopic adnexal surgery.
Women aged 18 and above with an indication for adnexal surgery for benign gynecological pathology or prophylactic reasons will be able to participate.
Read more
After surgery the participants will answer a questioner, twice a day in seven days, about postoperative pain and how many units of analgesics they used.
Adnexal surgery is one of the most common surgical procedures performed in women and can either be performed to treat pathology as ovarian cysts or prophylactically in case of hereditary genetic alterations.
A laparoscopic technique is currently considered as gold standard for adnexal procedures. The latest advancement in minimally invasive surgery is vNOTES (vaginal natural orifice transluminal endoscopy), in which the entrance to the abdomen is performed by an anterior or more commonly posterior colpotomy rather than via the abdominal wall. The NOTABLE trial was a RCT showing that vNOTES adnexectomy was non-inferior to laparoscopy for successful removal of benign adnexa without conversion (Baekelandt). vNOTES adnexectomy had shorter surgical time, less use of analgesics and lower self-assessed VAS scores the first week post-operatively. The aim with our study is to compare postoperative pain after vNOTES versus laparoscopic adnexal surgery.
- Conditions
- Ovarian Cysts, Laparoscopic Gynecologic Surgery, vNOTES
- Being tested
- vNOTES adnexal surgery
- Keywords
- ADNOLA - A randomized controlled trial study comparing adnexal surgery by vNOTES or laparoscopy
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vNOTES adnexal surgeryProcedure or surgery
New minimalinvasive technique
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Adnexal surgery | Active comparator | Not described Receives: Procedure: vNOTES adnexal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain postoperatively by a VAS-scale
To compare postoperative pain after adnexal surgery performed by vNOTES or laparoscopy
Measured: 7 days postoperative
Secondary outcomes (7)
Painkillers used (amount)
Units of non-opioid analgesics Units of postoperative opioids
Measured: 7 days postoperatively
Perioperatively complications
The incidence of intra-operative complications, i.e. any adverse event before the end of the surgical intervention including injury to the bladder, ureter, bowel, or intrapelvic/intra-abdominal vessels, as a dichotomous outcome.
Measured: Perioperatively
Operation time
Operation time, measured as the time in minutes from the insertion of the bladder catheter to the end of vaginal/abdominal wound closure, as a continuous outcome.
Measured: Perioperatively
Postoperative complications
Postoperative complications: major bleeding or pelvic hematoma requiring transfusion. Infections of the vaginal incision, abdominal wall or wound, urinary tract, chest, or febrile episodes/unspecified infections. Thromboembolism. Postoperative ileus or wound dehiscence. Classified according to the Clavien- Dindo, classification as a dichotomous outcome.
Measured: 6 weeks postoperatively
Readmission
The rates of readmission requiring hospitalization for at least 24 hours for any adverse event causally related to the gynaecological intervention during the first six weeks after surgery, as a dichotomous outcome.
Measured: 6 weeks after surgery
Conversion rate
Conversion rates: the proportion of women treated by any other approach than the allocated technique as randomized, as a dichotomous outcome. vNOTES will most likely be converted to LSC and LSC to open surgery
Measured: Perioperatively
Surgeon's experience
Surgeon's experience of comfort and flow measured by a 0 to 10 mm VAS scale
Measured: Perioperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completionDec 2028 (estimated)
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 Ovarian CystsStudies 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
- Model description
- Pragmatic multicentre two-armed superiority randomized controlled trail. No blinding.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Stuart, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964594
- Sponsor's protocol ID
- 2025-00965-01
- Other IDs
- 2025
- Acronym
- ADNOLA
- Status last verified
- Apr 2025
- First submitted
- 1 May 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olsson KS, Baekelandt JF, Kallen K, Matak L, Caretto M, Wassen MMLH, Simoncini T, Stuart A. ADNOLA trial: a study-protocol - a randomised controlled trial study comparing adnexal surgery by vNOTES or laparoscopy. BMJ Open. 2026 May 26;16(5):e112126. doi: 10.1136/bmjopen-2025-112126.
PubMed 42191199
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Study Comparing Adnexal Surgery by vNOTES or Laparoscopy
- ClinicalTrials.gov ID
- NCT06964594
- Acronym / sponsor ID
- ADNOLA / 2025-00965-01
- Conditions
- Ovarian Cysts, Laparoscopic Gynecologic Surgery, vNOTES
- Keywords
- ADNOLA - A randomized controlled trial study comparing adnexal surgery by vNOTES or laparoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 9 May 2025 (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.
The aim with the study is to compare postoperative pain after vNOTES adnexal surgery versus laparoscopic adnexal surgery.
Women aged 18 and above with an indication for adnexal surgery for benign gynecological pathology or prophylactic reasons will be able to participate.
After surgery the participants will answer a questioner, twice a day in seven days, about postoperative pain and how many units of analgesics they used.
Adnexal surgery is one of the most common surgical procedures performed in women and can either be performed to treat pathology as ovarian cysts or prophylactically in case of hereditary genetic alterations.
A laparoscopic technique is currently considered as gold standard for adnexal procedures. The latest advancement in minimally invasive surgery is vNOTES (vaginal natural orifice transluminal endoscopy), in which the entrance to the abdomen is performed by an anterior or more commonly posterior colpotomy rather than via the abdominal wall. The NOTABLE trial was a RCT showing that vNOTES adnexectomy was non-inferior to laparoscopy for successful removal of benign adnexa without conversion (Baekelandt). vNOTES adnexectomy had shorter surgical time, less use of analgesics and lower self-assessed VAS scores the first week post-operatively. The aim with our study is to compare postoperative pain after vNOTES versus laparoscopic adnexal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pragmatic multicentre two-armed superiority randomized controlled trail. No blinding.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Adnexal surgery | Active comparator | Procedure: vNOTES adnexal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the trial.
- Female aged 18 years or above.
- Diagnosed with adnexal pathology or subject for prophylactic BSO.
Key exclusion criteria (7 listed)
- Female participant who is pregnant or planning pregnancy during course of the trial.
- Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
- Patients taking opioids or other painkillers routinely pre-operatively.
- Patients with chronic pelvic pain.
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 adnexal surgeryNew minimalinvasive technique | Procedure or surgery | Laparoscopic Adnexal surgery |
Primary outcome
Pain postoperatively by a VAS-scale
Time frame: 7 days postoperative
To compare postoperative pain after adnexal surgery performed by vNOTES or laparoscopy
7 secondary outcomes
Painkillers used (amount)
Time frame: 7 days postoperatively
Perioperatively complications
Time frame: Perioperatively
Operation time
Time frame: Perioperatively
Postoperative complications
Time frame: 6 weeks postoperatively
Readmission
Time frame: 6 weeks after surgery
Conversion rate
Time frame: Perioperatively
Surgeon's experience
Time frame: Perioperatively
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 9 May 2025.
- Derived from this study: PubMed 42191199Olsson KS, Baekelandt JF, Kallen K, Matak L, Caretto M, Wassen MMLH, Simoncini T, Stuart A. ADNOLA trial: a study-protocol - a randomised controlled trial study comparing adnexal surgery by vNOTES or laparoscopy. BMJ Open. 2026 May 26;16(5):e112126. doi: 10.1136/bmjopen-2025-112126.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing vNOTES adnexal surgery in people with Ovarian Cysts and Laparoscopic Gynecologic Surgery, run by Region Skane.
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 7 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: opening soon, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Andrea E Stuart, M.D Associate Professor (0046736400760, andrea.stuart@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain postoperatively by a VAS-scale (time frame: 7 days postoperative). 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 NCT06964594, 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 9 May 2025.