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NCT05376384: OC-ESS

Ovarian Cyst's Enucleation Spillage Score

Completed Last updated 17 April 2024
What this trial tests

trial testing ultrasound parameters in Ovarian Cysts in 129 participants. Completed in 1 April 2024.

Timeline
12 May 2022
Primary endpoint
31 March 2024
1 April 2024

Quick facts

Lead sponsorUniversity of Campania Luigi Vanvitelli
StatusCompleted
Study typeOBSERVATIONAL
Enrollment129
Start date12 May 2022
Primary completion31 March 2024
Estimated completion1 April 2024
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Campania Luigi Vanvitelli

Who can join

18 and older, female only, with Ovarian Cysts or Spillage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Cystic enucleation is one of the most common conservative surgeries in gynecology; it is commonly performed by a minimally invasive approach such as laparoscopy. A high percentage of these surgeries (6-88 % of cases) are complicated by the cystic rupture with intra-abdominal spillage of its contents (spillage). This occurrence affects the surgical and prognostic outcome by lengthening the time of surgery, increasing the risk of postoperative infection or granulomatous peritonitis, of possible second manifestation of the pathology (example: endometriosis), and in the case of neoformation of a carcinomatous nature by leading to an increase in the stage of disease, exposing patients to a prognostic disadvantage and the need for adjuvant treatments also avoidable. In addition, the previous spillage may be associated with the adherent syndrome with repercussions on patients' morbidity and fertility. For these reasons, it is crucial to optimize the selection of patients who are candidates for cystic enucleation. The present study aims to evaluate a series of ultrasound, medical history, and surgical-preoperative parameters to develop a predictive score for the risk of spillage during laparoscopic surgery. Prospective Observational Study. The study aims to enroll 156 patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Minimally Invasive Staging of Early-Stage Epithelial Ovarian Cancer versus Open Surgery in Terms of Feasibility and Safety: A Systematic Review and Meta-Analysis.
    Ronsini C, Pasanisi F, Molitierno R, Iavarone I, et al · · 2023 · cited 15× · PMID 37298026 · DOI 10.3390/jcm12113831

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Other trials of ultrasound parameters

Trials testing the same drug.

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Other University of Campania Luigi Vanvitelli trials

Trials by the same sponsor.

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Data sources for this page

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