Learning Curve for the Visualization of Sacral Plexus on TVS

NCT06041347 | Unknown

• 1 other identifier: Semmelweis University Szabó G
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

Brief 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. The investigators aim to evaluate to evaluate the number needed to gain competence or to review the level of competence.

Conditions

Endometriosis; Nerve Sheath Tumor; Radiculopathy

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (3)

• inter and intraobserver variability

  12 months

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

  12 months

• differences between participating centers.

  12 months

Interventions

Transvaginal ultrasound DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients with pelvic pain scheduled for TVS

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead
• Jagiellonian University: collaborator
• Charles University, Czech Republic: collaborator
• St John of God Hospital, Vienna: collaborator

Study Sites (1)

Gábor Szabó

Budapest, 1088, Hungary

Location

Related Publications (2)

• 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.

  PMID: 36938682 RESULT

• 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.

  PMID: 37058402 RESULT

MeSH Terms

Conditions

Endometriosis; Nerve Sheath Neoplasms; Radiculopathy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Gábor Szabó, PhD

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gábor Szabó, PhD

CONTACT

+36204554710; szabo.gabor6@med.semmelweis-univ.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 18, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)