Evaluating inflammation's role in endometriosis outcomes after surgery
Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes
This study is trying to see how changes in inflammation after endometriosis surgery affect recovery and the chances of getting pregnant for women who have the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT06470594 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess changes in systemic inflammation markers following surgery for superficial, ovarian, or deep endometriosis. It will track patients already scheduled for surgery and evaluate how these inflammation parameters correlate with clinical outcomes, particularly in relation to pelvic pain and reproductive success for women wishing to conceive. The study will measure specific ratios of blood cells before and after surgery to understand their impact on recovery and fertility.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 45 who are scheduled for laparoscopic surgery for endometriosis and can commit to a 12-month postoperative follow-up.
Not a fit: Patients with a history of inflammatory, rheumatologic, or immunologic diseases, or those with certain malignancies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how inflammation affects recovery and reproductive outcomes in women with endometriosis.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated that inflammation can play a significant role in endometriosis outcomes, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Naples
- University of Campania Luigi Vanvitelli — Naples, Italy (Recruiting)
Study contacts
- Study coordinator: Gaetano Riemma, MD
- Email: gaetano.riemma@unicampania.it
- Phone: 0038 0815665599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.