Ovarian Cyst's Enucleation Spillage Score

Ovarian Cysts Clinical Trial

— OC-ESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376384
• Other study ID #: 0013958/i-
• Status: Completed
• Start date: May 12, 2022
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: April 1, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cysts
• Ovarian Cysts

Intervention

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

Locations

Country	Name	City	State
Italy	Università degli Studi della Campania Luigi Vanvitelli	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spillage Rate	Identification of spillage rate during laparoscopic cystic enucleation in patients with the risk factors considered.	12 months