Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions

NCT06988280RecruitingOBSERVATIONAL

Summary

Key Facts

Lead Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

100

Start Date

2025-03-13

Completion Date

2027-12-01

Study Type

OBSERVATIONAL

Official Title

Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions

Interventions

Ultrasound-guided transvaginal aspiration of cystic pelvic lesions.

Conditions

Pelvic AbscessAdnexal CystOvarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Participants eligible for inclusion in this study must meet all of the following criteria:

1. Lesion criteria applicable for therapeutic intervention

   1. Safe accessibility of the lesion (within reach of aspiration needle; visible on ultrasound; transvaginal access; no interposition of bowel or blood vessels)
   2. Lesion types included: cystic lesions (adnexal cysts), pelvic inclusion cysts (pseudocysts), pelvic abscesses
2. Indications

   1. Pain relief in symptomatic cystic lesions with benign appearance.
   2. Symptomatic treatment in probably malignant lesions (only in non-curative setting).

Exclusion Criteria:

1. Patients \<18 years
2. Poor performance status contra-indicating the procedure
3. Vaginal stenosis (severe atrophy - virgo - vaginismus)
4. Purely solid lesions
5. Cystic lesions with a presumed malignant diagnosis and a risk of tumor dissemination in a curative setting
6. Physiological cysts in asymptomatic patients (in case of doubt the patient is reassessed after 3-6 months)

Outcome Measures

Primary Outcomes

Pain on verbal rating scale (0-10)

Pain scores indicated by the patient prior to the procedure, during the procedure, one week after and three months after the procedure.

Time frame: • Pain scores indicated by the patient prior to the procedure, during the procedure, one week after and three months after the procedure (based on a verbal rating scale).

Recurrence of cyst (binary outcome after 12 months)

Clinical and sonographic follow-up of possible recurrence (up till 12 months). Routine assessment will be done after 3 and 12 months

Time frame: 12 months

Secondary Outcomes

General experience during the procedure (based on verbal rating scale 0-10)

General experience during the procedure based on verbal rating scale, assessed after the procedure by an independent examiner.

Time frame: Right after the procedure to 3 days after.

Complications (based on Clavien Dindo classification)

Registration of adverse events, such as Vasovagal reaction, bleeding, infection, excessive pain.

Time frame: Immediately after the procedure to 6 weeks after the procedure.

Locations

University Hospitals Leuven, Leuven, Belgium

Ultrasound-guided Transvaginal Aspiration of Cystic Pelvic Lesions