Ovarian CystsOC-ESSNCT05376384
Ovarian Cyst's Enucleation Spillage Score
An observational study of Ovarian Cysts and Spillage, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cysts, Spillage
- What is being tested?
- ultrasound parameters and intraoperative parameters
- Type of treatment
- Surgery or procedure
- How many people
- 129 participants
- Where
- 1 siteItaly
- Study dates
- 12 May 2022to 1 Apr 2024
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients in the Naples Metropolitan area, southern Italy, where our university hospital is located, suffering from adnexal cystic neoformation for which they need to undergo laparoscopic cystic enucleation surgery. Patients will receive the standard of care regardless of participation in the study, in which they will participate voluntarily and after signing informed consent.
Who may be able to join
- 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
Who cannot join
- Pregnancy status
- Patients with cardiological, neurological, or metabolic disorders not treated pharmacologically
- ASA III
- Patients undergoing laparotomy conversion prior to enucleation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Università degli Studi della Campania Luigi Vanvitelli
Naples, 80138
About this study
Official title: Ovarian Cyst's Enucleation Spillage Score. An Observational Study of Cyst Characteristics for Spillage During Laparoscopic Enucleation
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.
- Conditions
- Ovarian Cysts, Spillage
- Being tested
- ultrasound parameters, intraoperative parameters
- Keywords
- ovarian cysts, laparoscopy, cyst enucleation, spillage
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound parametersDiagnostic test
Annotation of ultrasonographic features of ovarian cyst. The parts examined are size, laterality, content, margins, and color score.
intraoperative parametersProcedure or surgery
Annotation of intraoperative features of ovarian cyst. The characteristics under review are: surgeon experience, previous surgery, adhesions, and uterine manipulator use
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients, over 18 years old, undergoing laparoscopic cyst enucleation surgery with an occasional, unanticipated finding of cyst rupture and intraoperative spillage Receives: Diagnostic Test: ultrasound parameters; Procedure: intraoperative parameters | |
| Control | Patients, over 18 years old, undergoing laparoscopic cystic enucleation surgery with the extraction of the intact operative specimen. Receives: Diagnostic Test: ultrasound parameters; Procedure: intraoperative parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spillage Rate
Identification of spillage rate during laparoscopic cystic enucleation in patients with the risk factors considered.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start12 May 2022
- Primary completion31 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CystsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Ronsini, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376384
- Sponsor's protocol ID
- 0013958/i-
- Acronym
- OC-ESS
- Status last verified
- Apr 2024
- First submitted
- 12 May 2022
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian Cyst's Enucleation Spillage Score. An Observational Study of Cyst Characteristics for Spillage During Laparoscopic Enucleation
- ClinicalTrials.gov ID
- NCT05376384
- Acronym / sponsor ID
- OC-ESS / 0013958/i-
- Conditions
- Ovarian Cysts, Spillage
- Keywords
- ovarian cysts, laparoscopy, cyst enucleation, spillage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 12 May 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Diagnostic Test: ultrasound parameters, Procedure: intraoperative parametersPatients, over 18 years old, undergoing laparoscopic cyst enucleation surgery with an occasional, unanticipated finding of cyst rupture and intraoperative spillage |
| Control | – | Diagnostic Test: ultrasound parameters, Procedure: intraoperative parametersPatients, over 18 years old, undergoing laparoscopic cystic enucleation surgery with the extraction of the intact operative specimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the Naples Metropolitan area, southern Italy, where our university hospital is located, suffering from adnexal cystic neoformation for which they need to undergo laparoscopic cystic enucleation surgery. Patients will receive the standard of care regardless of participation in the study, in which they will participate voluntarily and after signing informed consent.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy status
- Patients with cardiological, neurological, or metabolic disorders not treated pharmacologically
- ASA III
- Patients undergoing laparotomy conversion prior to enucleation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound parametersAnnotation of ultrasonographic features of ovarian cyst. The parts examined are size, laterality, content, margins, and color score. | Diagnostic test | Case, Control |
| intraoperative parametersAnnotation of intraoperative features of ovarian cyst. The characteristics under review are: surgeon experience, previous surgery, adhesions, and uterine manipulator use | Procedure or surgery | Case, Control |
Primary outcome
Spillage Rate
Time frame: 12 months
Identification of spillage rate during laparoscopic cystic enucleation in patients with the risk factors considered.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cysts and Spillage, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spillage Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.