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

NCT ID: NCT06470594

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-29

Study Completion Date

2026-06-30

Brief Summary

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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)

Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Superficial Endometriosis

Laparoscopic excision of superficial (peritoneal) endometriotic implants

No interventions assigned to this group

Ovarian Endometriosis

Laparoscopic excision of ovarian endometrioma/s

No interventions assigned to this group

Deep Infiltrating Endometriosis (DIE)

Laparoscopic excision of DIE

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Riemma

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Campania Luigi Vanvitelli

Napoli, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Gaetano Riemma, MD

Role: CONTACT

0038 0815665599

Facility Contacts

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Gaetano Riemma

Role: primary

Other Identifiers

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0016489/i

Identifier Type: -

Identifier Source: org_study_id

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