Ovarian Cyst's Enucleation Spillage Score

NCT05376384 | Completed

• 1 other identifier: 0013958/i-
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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

Keywords

ovarian cysts; laparoscopy; cyst enucleation; spillage

Outcome Measures

Primary Outcomes (1)

• Spillage Rate

  Identification of spillage rate during laparoscopic cystic enucleation in patients with the risk factors considered.

  12 months

Study Arms (2)

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; Procedure: intraoperative parameters

Control

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

Diagnostic Test: ultrasound parameters; Procedure: intraoperative parameters

Interventions

ultrasound parameters DIAGNOSTIC_TEST

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

Case; Control

intraoperative parameters PROCEDURE

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

Case; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Università degli Studi della Campania Luigi Vanvitelli

Naples, 80138, Italy

Location

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 17, 2022
• Study Start: May 12, 2022
• Primary Completion: March 31, 2024
• Study Completion: April 1, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)