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

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Ovarian Cysts; Spillage

Treatments: Diagnostic Test: ultrasound parameters; Procedure: intraoperative parameters

Study type: Observational

Funder types: Other

Identifiers

NCT05376384

0013958/i-

Details and patient eligibility

About

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.

Enrollment: 129 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

129 participants in 2 patient groups

Case

Description:

Patients, over 18 years old, undergoing laparoscopic cyst enucleation surgery with an occasional, unanticipated finding of cyst rupture and intraoperative spillage

Treatment:

Procedure: intraoperative parameters

Diagnostic Test: ultrasound parameters

Control

Description:

Patients, over 18 years old, undergoing laparoscopic cystic enucleation surgery with the extraction of the intact operative specimen.

Treatment:

Procedure: intraoperative parameters

Diagnostic Test: ultrasound parameters