Ovarian Cyst's Enucleation Spillage Score

Completed

• Conditions: Ovarian Cysts; Spillage
• Interventions: Diagnostic Test: ultrasound parameters; Procedure: intraoperative parameters

• Registration Number: NCT05376384
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-12
• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-17
• Primary Completion: 2024-03-31
• Status Verified: 2024-04
• Study Completion: 2024-04-01
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 129

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	intraoperative parameters	Patients, over 18 years old, undergoing laparoscopic cystic enucleation surgery with the extraction of the intact operative specimen.
Case	ultrasound parameters	Patients, over 18 years old, undergoing laparoscopic cyst enucleation surgery with an occasional, unanticipated finding of cyst rupture and intraoperative spillage
Case	intraoperative parameters	Patients, over 18 years old, undergoing laparoscopic cyst enucleation surgery with an occasional, unanticipated finding of cyst rupture and intraoperative spillage
Control	ultrasound parameters	Patients, over 18 years old, undergoing laparoscopic cystic enucleation surgery with the extraction of the intact operative specimen.

Primary Outcome Measures

Name	Time	Method
Spillage Rate	12 months	Identification of spillage rate during laparoscopic cystic enucleation in patients with the risk factors considered.

Trial Locations

Locations (1)

Università degli Studi della Campania Luigi Vanvitelli; 🇮🇹 Naples, Italy