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

U

University of Campania "Luigi Vanvitelli"

Status

Enrolling

Conditions

Endometriosis

Study type

Observational

Funder types

Other

Identifiers

NCT06470594
0016489/i

Details and patient eligibility

About

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)

Enrollment

138 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

138 participants in 3 patient groups

Superficial Endometriosis
Description:
Laparoscopic excision of superficial (peritoneal) endometriotic implants
Ovarian Endometriosis
Description:
Laparoscopic excision of ovarian endometrioma/s
Deep Infiltrating Endometriosis (DIE)
Description:
Laparoscopic excision of DIE

Trial contacts and locations

1

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Central trial contact

Gaetano Riemma, MD

Data sourced from clinicaltrials.gov

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