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OpenTrials
Completed

NCT Number: NCT05376384

Ovarian Cyst's Enucleation Spillage Score

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Università degli Studi della Campania Luigi Vanvitelli

Naples, 80138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound parameters

Diagnostic Test

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

intraoperative parameters

Procedure

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

Primary outcomes

  1. Spillage Rate

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

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

Acronym: OC-ESS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 17, 2022
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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