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Uterosacral ligament thickness: a novel ultrasound measurement for diagnosing endometriosis

Ultrasound assessment of the uterosacral ligaments and diagnostic accuracy for peritoneal endometriosis: A pilot single-centre prospective study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001324808
Enrollment
8
Registered
2021-09-29
Start date
2021-07-12
Completion date
2022-01-31
Last updated
2021-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Endometriosis is a common and chronic condition. Whilst deep forms of the disease (ovarian endometriomas and deep-infiltrating endometriosis) are reliably diagnosed on ultrasound prior to surgery, superficial pelvic disease is not. This pilot study aims to assess a new ultrasound measurement to determine its accuracy in diagnosing superficial endometriosis. Patients scheduled for key-hole surgery will undergo pelvic ultrasound 1-2 months before surgery, then standardised surgical samples of the uterosacral ligaments (fibrous bands originating at the lower uterus) will be analysed. Should this ultrasound measurement be successful, it will improve diagnostics for endometriosis, and guide which patients may benefit most from surgery.

Interventions

All participants will complete a transvaginal ultrasound within 8 weeks prior to the planned laparoscopy (laparoscopy planned independent of the study). The ultrasound will take approximately 15minutes. -- All findings of deep endometriosis will be reported to the managing surgical teams, along with any other sinister pathological concerns. The additional assessment on pelvic ultrasound will include a measurement (in mm) of both USLs. This will be completed in an axial plane at the level of the

All participants will complete a transvaginal ultrasound within 8 weeks prior to the planned laparoscopy (laparoscopy planned independent of the study). The ultrasound will take approximately 15minutes. -- All findings of deep endometriosis will be reported to the managing surgical teams, along with any other sinister pathological concerns. The additional assessment on pelvic ultrasound will include a measurement (in mm) of both USLs. This will be completed in an axial plane at the level of the internal cervical os, 10 mm from the medial insertion of the ligament. The measurement will include the lipomatous layer of the USL in this plane and will exclude the vascular and neural components of the ligament. In addition to this objective measurement, the mobility of the USLs, tenderness of the USLs and tenderness of the pelvic floor muscles will be dichotomised and recorded as yes/no. The USL measurements will not be reported to the managing clinicians. The assessment of the USL is not included in the current ASUM reporting guidelines for pelvic imaging. On the same day as the ultrasound, a 15minute questionnaire will be completed by the participant. All participants will undergo their scheduled laparoscopic pelvic surgery, as was planned irrespective of study involvement. The surgeon will capture standardised clinical pictures, plus additional pictures of visible disease. The surgeon will then take the standardised biopsies of each USL. These biopsies are to be taken at a standardized point (10mm from the medial insertion) and be of a size at least 10mm x 3mmThe surgery will then be completed with excision of other visible disease. The surgeon will complete a 5minute form describing the surgical findings. Histological specimens will be processed in the standard way by two anatomical pathologists.

Sponsors

Mercy Hospital for Women
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

Inclusion Criteria (high-risk cohort): 1. Age 18yrs and older 2. Pre-menopausal 3. Women with pain and/or infertility 4. Women waitlisted for laparoscopy +/- treatment of endometriosis Inclusion Criteria (low-risk cohort): 1. Age 18yrs and older 2. Pre-menopausal 3. Booked for laparoscopy for an indication other than pelvic pain and/or infertility

Exclusion criteria

1. Prior laparoscopy and treatment of endometriosis 2. Post-menopausal 3. Prior hysterectomy 4. Prior imaging evidence of grade III/IV endometriosis 5. Diagnosis on pre-operative ultrasound of endometrioma or deep endometriosis 6. Not consenting to transvaginal pelvic ultrasound 7. Non-english speaking

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026