EndometriosisESPRIMO-CCRNCT06470594
Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes
An observational study of Endometriosis, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Primary aim of this study is to evaluate the change in systemic inflammation parameters after surgery for superficial, ovarian or deep endometriosis. Secondary objectives focus on correlating these parameters to clinical outcomes, in patients with pelvic pain, and reproductive outcomes, in women desiring offspring. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- How many people
- 138 participants
- Where
- 1 siteItaly
- Study dates
- 29 May 2024to Jun 2026
- 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 to 45 years
- Women only
- Adult
Study population: Women with chronic pelvic pain and/or infertility with a sonographic or MRI ascertained suspicion of endometriosis.
Who may be able to join
- Age between 18 and 45 years.
- Postoperative follow-up of at least 12 months;
- Signature of informed consent regarding laparoscopic surgical treatment.
- Signature of informed consent to the processing of personal data duly documented by medical records.
Who cannot join
- Failure to sign informed consent for laparoscopic surgical treatment
- Histologic diagnosis of borderline tumor and/or ovarian carcinoma and/or mucinous cystadenoma and/or germ cell tumor or other malignancy of the genital tract
- postoperative follow-up of less than 12 months;
- documented history of inflammatory, rheumatologic, or immunologic disease; and
- failure to provide informed consent for personal data processing.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Campania Luigi Vanvitelli
Naples, 80138
Gaetano Riemma
Pasquale De Franciscis, MD PhD
About this study
Primary aim of this study is to evaluate the change in systemic inflammation parameters after surgery for superficial, ovarian or deep endometriosis. Secondary objectives focus on correlating these parameters to clinical outcomes, in patients with pelvic pain, and reproductive outcomes, in women desiring offspring.
Participants already scheduled for surgery as part of their endometriosis care will be followed regarding the abovementioned outcomes after calculation of pre and postsurgical systemic inflammation markers (neutrophil to lymphocyte ratio; platelet to lymphocyte ratio and lymphocyte to monocyte ratio)
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Superficial Endometriosis | Laparoscopic excision of superficial (peritoneal) endometriotic implants | |
| Ovarian Endometriosis | Laparoscopic excision of ovarian endometrioma/s | |
| Deep Infiltrating Endometriosis (DIE) | Laparoscopic excision of DIE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil to lymphocyte ratio
Measured: Measured before and after (24 to 72 hours) surgery
Secondary outcomes (2)
Platelet to lymphocyte ratio
Measured: Measured before and after (24 to 72 hours) surgery
Lymphocyte to monocyte ratio
Measured: Measured before and after (24 to 72 hours) surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start29 May 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Riemma, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470594
- Sponsor's protocol ID
- 0016489/i
- Acronym
- ESPRIMO-CCR
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes
- ClinicalTrials.gov ID
- NCT06470594
- Acronym / sponsor ID
- ESPRIMO-CCR / 0016489/i
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 24 Jun 2024 (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.
Primary aim of this study is to evaluate the change in systemic inflammation parameters after surgery for superficial, ovarian or deep endometriosis. Secondary objectives focus on correlating these parameters to clinical outcomes, in patients with pelvic pain, and reproductive outcomes, in women desiring offspring.
Participants already scheduled for surgery as part of their endometriosis care will be followed regarding the abovementioned outcomes after calculation of pre and postsurgical systemic inflammation markers (neutrophil to lymphocyte ratio; platelet to lymphocyte ratio and lymphocyte to monocyte ratio)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Superficial Endometriosis | – | –Laparoscopic excision of superficial (peritoneal) endometriotic implants |
| Ovarian Endometriosis | – | –Laparoscopic excision of ovarian endometrioma/s |
| Deep Infiltrating Endometriosis (DIE) | – | –Laparoscopic excision of DIE |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women with chronic pelvic pain and/or infertility with a sonographic or MRI ascertained suspicion of endometriosis.
Key inclusion criteria (4 listed)
- Age between 18 and 45 years.
- Postoperative follow-up of at least 12 months;
- Signature of informed consent regarding laparoscopic surgical treatment.
- Signature of informed consent to the processing of personal data duly documented by medical records.
Key exclusion criteria (5 listed)
- Failure to sign informed consent for laparoscopic surgical treatment
- Histologic diagnosis of borderline tumor and/or ovarian carcinoma and/or mucinous cystadenoma and/or germ cell tumor or other malignancy of the genital tract
- postoperative follow-up of less than 12 months;
- documented history of inflammatory, rheumatologic, or immunologic disease; and
- failure to provide informed consent for personal data processing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neutrophil to lymphocyte ratio
Time frame: Measured before and after (24 to 72 hours) surgery
2 secondary outcomes
Platelet to lymphocyte ratio
Time frame: Measured before and after (24 to 72 hours) surgery
Lymphocyte to monocyte ratio
Time frame: Measured before and after (24 to 72 hours) surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
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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.
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 Endometriosis, 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 24 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gaetano Riemma, MD (0038 0815665599, gaetano.riemma@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil to lymphocyte ratio (time frame: Measured before and after (24 to 72 hours) surgery). 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 24 Jun 2024.