Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes (ESPRIMO-CCR)

June 17, 2024 updated by: Gaetano Riemma, University of Campania "Luigi Vanvitelli"

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Napoli, Italy, 80138
        • Recruiting
        • University of Campania Luigi Vanvitelli
        • Contact:
          • Gaetano Riemma
        • Sub-Investigator:
          • Pasquale De Franciscis, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Women with chronic pelvic pain and/or infertility with a sonographic or MRI ascertained suspicion of endometriosis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neutrophil to lymphocyte ratio
Time Frame: Measured before and after (24 to 72 hours) surgery
Measured before and after (24 to 72 hours) surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Platelet to lymphocyte ratio
Time Frame: Measured before and after (24 to 72 hours) surgery
Measured before and after (24 to 72 hours) surgery
Lymphocyte to monocyte ratio
Time Frame: Measured before and after (24 to 72 hours) surgery
Measured before and after (24 to 72 hours) surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 17, 2024

First Submitted That Met QC Criteria

June 17, 2024

First Posted (Actual)

June 24, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 17, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0016489/i

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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