Superficial and Deep Endometriosis: Role of Systemic Inflammation as a Marker of Clinical, Surgical, and Reproductive Outcomes

NCT06470594 | Recruiting

• 1 other identifier: 0016489/i
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Neutrophil to lymphocyte ratio

  Measured before and after (24 to 72 hours) surgery

Secondary Outcomes (2)

• Platelet to lymphocyte ratio

  Measured before and after (24 to 72 hours) surgery

• Lymphocyte to monocyte ratio

  Measured before and after (24 to 72 hours) surgery

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli

Napoli, 80138, Italy

RECRUITING

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Gaetano Riemma, MD

CONTACT

0038 0815665599; gaetano.riemma@unicampania.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: May 29, 2024
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

IT (1)