NCT05376384Completed
Ovarian Cyst's Enucleation Spillage Score
Ovarian Cyst's Enucleation Spillage Score. An Observational Study of Cyst Characteristics for Spillage During Laparoscopic Enucleation
Source: ClinicalTrials.gov · Last updated 17 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 129 (actual)
- First submitted
- 12 May 2022
- Start date
- May 2022
- Primary completion date
- Mar 2024
- Lead sponsor
- University of Campania Luigi Vanvitelli
- NCT number
- NCT05376384
What you commit to
- Study type: Observational
- Participants enrolled: 129
- From May 2022 to the primary completion date, Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing laparotomy conversion prior to enucleation
Other illness
- Patients with cardiological, neurological, or metabolic disorders not treated pharmacologically
Other
- Pregnancy status
- ASA III
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.