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Ovarian Cyst's Enucleation Spillage Score

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05376384
Acronym
OC-ESS
Enrollment
129
Registered
2022-05-17
Start date
2022-05-12
Completion date
2024-04-01
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cysts, Spillage

Keywords

ovarian cysts, laparoscopy, cyst enucleation, spillage

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.

Interventions

DIAGNOSTIC_TESTultrasound parameters

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

PROCEDUREintraoperative parameters

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

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Spillage Rate12 monthsIdentification of spillage rate during laparoscopic cystic enucleation in patients with the risk factors considered.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026