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

Ovarian Cyst's Enucleation Spillage Score. An Observational Study of Cyst Characteristics for Spillage During Laparoscopic Enucleation

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Cysts; Spillage
• Intervention / Treatment: Diagnostic test: ultrasound parameters; Procedure: intraoperative parameters

• Study Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80138
    • Università degli studi della Campania Luigi Vanvitelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in the Naples Metropolitan area, southern Italy, where our university hospital is located, suffering from adnexal cystic neoformation for which they need to undergo laparoscopic cystic enucleation surgery. Patients will receive the standard of care regardless of participation in the study, in which they will participate voluntarily and after signing informed consent.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Case; Patients, over 18 years old, undergoing laparoscopic cyst enucleation surgery with an occasional, unanticipated finding of cyst rupture and intraoperative spillage	Diagnostic test: ultrasound parameters; Annotation of ultrasonographic features of ovarian cyst. The parts examined are size, laterality, content, margins, and color score.; Procedure: intraoperative parameters; Annotation of intraoperative features of ovarian cyst. The characteristics under review are: surgeon experience, previous surgery, adhesions, and uterine manipulator use
Control; Patients, over 18 years old, undergoing laparoscopic cystic enucleation surgery with the extraction of the intact operative specimen.	Diagnostic test: ultrasound parameters; Annotation of ultrasonographic features of ovarian cyst. The parts examined are size, laterality, content, margins, and color score.; Procedure: intraoperative parameters; Annotation of intraoperative features of ovarian cyst. The characteristics under review are: surgeon experience, previous surgery, adhesions, and uterine manipulator use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spillage Rate	Identification of spillage rate during laparoscopic cystic enucleation in patients with the risk factors considered.	12 months

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopy; ovarian cysts; cyst enucleation; spillage
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Cysts; Cysts
• Other Study ID Numbers: 0013958/i-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No