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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05376384
Other study ID # 0013958/i-
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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