Ovarian Cyst's Enucleation Spillage Score

Study Overview
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Brief Summary
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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.

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

Conditions
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Ovarian Cysts, Spillage

Intervention / Treatment
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* Diagnostic Test: ultrasound parameters
* Procedure: intraoperative parameters


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>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<br>* Annotation of ultrasonographic features of ovarian cyst. The parts examined are size, laterality, content, margins, and color score.<br>Procedure: intraoperative parameters<br>* Annotation of intraoperative features of ovarian cyst. The characteristics under review are: surgeon experience, previous surgery, adhesions, and uterine manipulator use<br>|
| Control<br>Patients, over 18 years old, undergoing laparoscopic cystic enucleation surgery with the extraction of the intact operative specimen. | Diagnostic Test: ultrasound parameters<br>* Annotation of ultrasonographic features of ovarian cyst. The parts examined are size, laterality, content, margins, and color score.<br>Procedure: intraoperative parameters<br>* Annotation of intraoperative features of ovarian cyst. The characteristics under review are: surgeon experience, previous surgery, adhesions, and uterine manipulator use<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, ovarian cysts, cyst enucleation, spillage