Ovarian Cyst's Enucleation Spillage Score

NCT ID: NCT05376384

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-12
• Study Completion Date: 2024-04-01

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.

Conditions

Ovarian Cysts; Spillage

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case

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

ultrasound parameters

Intervention Type: DIAGNOSTIC_TEST

Annotation of ultrasonographic features of ovarian cyst. The parts examined are size, laterality, content, margins, and color score.

intraoperative parameters

Intervention Type: PROCEDURE

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.

ultrasound parameters

Intervention Type: DIAGNOSTIC_TEST

Annotation of ultrasonographic features of ovarian cyst. The parts examined are size, laterality, content, margins, and color score.

intraoperative parameters

Intervention Type: PROCEDURE

Annotation of intraoperative features of ovarian cyst. The characteristics under review are: surgeon experience, previous surgery, adhesions, and uterine manipulator use

Interventions

ultrasound parameters

Annotation of ultrasonographic features of ovarian cyst. The parts examined are size, laterality, content, margins, and color score.

Intervention Type: DIAGNOSTIC_TEST

intraoperative parameters

Annotation of intraoperative features of ovarian cyst. The characteristics under review are: surgeon experience, previous surgery, adhesions, and uterine manipulator use

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role: lead

Responsible Party

Carlo Ronsini

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Università degli Studi della Campania Luigi Vanvitelli

Naples, , Italy

Countries

Italy

Other Identifiers

0013958/i-

Identifier Type: -

Identifier Source: org_study_id