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EndometriosisPlexUSNCT06041347

Learning Curve for the Visualization of Sacral Plexus on TVS

An observational study of Endometriosis and Nerve Sheath Tumor, run by Semmelweis University at 1 site in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this prospective study was to evaluate the learning curve of TVUS (transvaginal ultrasound) for the visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Endometriosis, Nerve Sheath Tumor, Radiculopathy
What is being tested?
Transvaginal ultrasound
How many people
480 participants
Where
1 siteHungary
Study dates
1 Oct 2023to 31 Dec 2025
Phase
Observational
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants are consecutive patients of the Gynecology and Endometriosis Ambulance of the participating centres.

Who may be able to join

  • Patients with pelvic pain scheduled for TVS

Who cannot join

  • 18 years
  • Women who have never been sexually active
  • (suspected) Pelvic malignancy for example gynecological, intestinal or urological malignancy
  • Premenarche
  • Pregnancy
  • Patients refusal to participate to the study

Trial locations and contacts

1 site in 1 country.

Hungary1 site
  • Gábor Szabó

    Budapest, 1088

Other trials in Hungary

About this study

Official title: Evaluation of the Learning Curve for the Visualization of Sacral Nerve Roots and Sacral Plexus on Gynecological Transvaginal Ultrasound - PlexUS Study

The purpose of this prospective study was to evaluate the learning curve of TVUS (transvaginal ultrasound) for the visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound. The investigators aim to evaluate to evaluate the number needed to gain competence or to review the level of competence.

Read the detailed description

For each patient, the fellows are blinded to the clinical and surgical history. The investigators will be aware that all patients were being evaluated for pelvic pain or endometriosis. The expert sonographer assess the patient and visualized the sacral roots and the sacral plexus first as part of the advanced TVUS examination for endometriosis.

TVUS examination will conducted in six steps eas follows in six successive steps. All women will be asked to empty their bladder prior to examination. TVUS scans will be performed in the lithotomy position in a standardized fashion using a transvaginal probe Step 1: First the probe will inserted into the anterior vaginal fornix. The uterus is examined in the midsagittal view on the longitudinal section to identify the cervix and the uterine cavity. The image is frozen with time displayed on the screen, which was marked as Time 1.

Step 2: The image is unfrozen and at the level of the inner cervical meatus the transducer is rotated 90 degrees counterclockwise to obtain a transverse scan.

Step 3: Then the probe is immediately moved towards the right lateral fornix pointing towards the uterine vessels, which appear as hypoechoic bands. Behind these structures, a thick hyperechoic band - the left uterosacral ligament -appears, starting from the cervix and pointing laterally in a semi horizontal direction. By rotating the probe the uterosacral ligament is then followed from medial to lateral, up to the lateral pelvic wall. The obturator internus muscle covers most of the lateral wall of the pelvis minor, which - in transverse scan - is a hypoechoic thin band just lateral to the uterosacral ligament. On the lateral side of the muscle a continuous bright white band is seen, corresponding to the body of the ischium.

Step 4: Sweeping the probe medially and pushing it superior the hypoechoic obturator internus muscle and the hyperechoic ischium are followed ending at the greater sciatic foramen. At this point transverse and oblique sections of the branches of the anterior division of the internal iliac vessels became visible. Deeper to the vessels the hypoechoic muscle fiber bundles with intervening echogenic perimysium, the piriformis muscle, and a bright white line, the anterior surface of the sacrum are visualized. Between the vessels and the piriformis muscle on conventional gray scale B mode the sacral roots of the sacral plexus (SP) appear in longitudinal section, with a typical "bundle of straw" appearance: hypoechoic bands, with echogenic septae. The hypoechoic areas correspond to nerve fascicles, while the hyperechoic septae correspond to the inner and outer epineurium. In transverse section, the nerves have a "honeycomb" shape echotexture.

Step 5: Pushing the transducer superior color Doppler and pulse wave Doppler can be used to differentiate blood vessels from the ureter on the lateral pelvic wall and to identify the branching of the internal iliac artery. From the posterior division rises the superior gluteal artery and from the anterior division originates the inferior gluteal artery. Both of them exiting the pelvis between the ischium and the sacrum. The former runs between the lumbosacral trunk and the ventral ramus of the S1 nerve and leaves the pelvis superior to the piriformis muscle. The inferior gluteal artery passes usually posteriorly between S2 and S3 roots, and leaves the pelvis together with the sciatic nerve, inferior to the piriformis muscle near to the transducer. When the sacral plexus was clearly visualized the image was frozen again and Time 2 was marked. The total time required to complete the visualization of the sacral plexus was calculated as Time 2 minus Time 1.

The diameter of the SP is measured in all patients in a transverse section at the notional intersection of the SP and a vertical line extending from the medial border of the obturator internus muscle. The measurement is taken by placing the caliper on the outer edge of hyperechoic epineurium. The same procedure is then repeated on the contralateral side.

Being tested
Transvaginal ultrasound
Medical subject headings
Endometriosis, Nerve Sheath Neoplasms, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transvaginal ultrasoundDiagnostic test

    Preoperative detection with TVUS of proximity or the involvement of the sacral nerve roots in women diagnosed with deep endometriosis or other benign or malignant pelvic tumors would also contribute to the safety of surgical interventions (e.g laparoscopy, tru-cut biopsy) It aslo provides correct counseling and select the appropriate surgical team and assess the likely operative complexity of the surgery. Until now the diagnosis was based on MRI.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of scans to gain competency for the visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound

    The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate.

    Measured: 12 months

Secondary outcomes (3)
  1. inter and intraobserver variability

    The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate

    Measured: 12 months

  2. differences between sonographers of different level of experience in the field of gynecological TVS.

    The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate

    Measured: 12 months

  3. differences between participating centers.

    The LC-CUSUM test will be used to monitor the performance of sequential interventions. Hereby the Null hypothesis (H0, performance is inadequate) is continuously tested against the alternative hypothesis (H1, performance is adequate). Negative scores for correct interventions and positive scores for incorrect results are calculated as previously reported by Biau et al. (2008a,b). Once the summation score reaches a predefined level (h) the test rejects the null hypothesis in favour of the alternative hypothesis indicating that the performance is adequate. After the literature(Tammaa 2014 and Ong 2020) we have chosen h: 1.25, P0: 0.175 as an unacceptable failure rate, and P1: 0.1, as an acceptable failure rate

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2023
  2. Study start1 Oct 2023 (estimated)
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06041347
Sponsor's protocol ID
Semmelweis University Szabó G
Acronym
PlexUS
Status last verified
Sep 2023
First submitted
5 Sep 2023
Last updated
18 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Szabo G, Madar I, Hudelist G, Aranyi Z, Turtoczki K, Rigo J Jr, Acs N, Liptak L, Fancsovits V, Bokor A. Visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound: feasibility study. Ultrasound Obstet Gynecol. 2023 Aug;62(2):290-299. doi: 10.1002/uog.26204.

    PubMed 36938682
  • Fischerova D, Santos G, Wong L, Yulzari V, Bennett RJ, Dundr P, Burgetova A, Barsa P, Szabo G, Sousa N, Scovazzi U, Cibula D. Imaging in gynecological disease (26): clinical and ultrasound characteristics of benign retroperitoneal pelvic peripheral-nerve-sheath tumors. Ultrasound Obstet Gynecol. 2023 Nov;62(5):727-738. doi: 10.1002/uog.26223.

    PubMed 37058402

Questions about this trial

What is this clinical trial studying?

An observational study of Endometriosis and Nerve Sheath Tumor, run by Semmelweis University at 1 site in Hungary.

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 6 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 18 Sep 2023. 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 Hungary. 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 Gábor Szabó, PhD (+36204554710, szabo.gabor6@med.semmelweis-univ.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of scans to gain competency for the visualization of sacral nerve roots and sacral plexus on gynecological transvaginal ultrasound (time frame: 12 months). 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 NCT06041347, 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 18 Sep 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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