Ovarian Cyst's Enucleation Spillage Score (OC-ESS)

  • STATUS
    Recruiting
  • End date
    May 12, 2023
  • participants needed
    156
  • sponsor
    University of Campania "Luigi Vanvitelli"
Updated on 3 June 2022

Summary

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.

Details
Condition Ovarian Cysts, Spillage
Treatment ultrasound parameters, intraoperative parameters
Clinical Study IdentifierNCT05376384
SponsorUniversity of Campania "Luigi Vanvitelli"
Last Modified on3 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients >18 years of age
Patients undergoing laparoscopic cystic enucleation
Patients who underwent pelvic ultrasound examination within 30 days prior to surgery
Patients who signed informed consent for the study
ECOG performance status < 2

Exclusion Criteria

Pregnancy status
Patients with cardiological, neurological, or metabolic disorders not treated pharmacologically
ASA III
Patients undergoing laparotomy conversion prior to enucleation
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