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

ConditionEndometriosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Campania Luigi Vanvitelli

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

138 Participants
are grouped into 3 trial groups
Group A: Superficial Endometriosis
Group B: Ovarian Endometriosis
Group C: Deep Infiltrating Endometriosis (DIE)

Trial outcomes

Primary outcomes

1

Neutrophil to lymphocyte ratio

Time frame
Measured before and after (24 to 72 hours) surgery

Secondary outcomes

1

Platelet to lymphocyte ratio

Time frame
Measured before and after (24 to 72 hours) surgery
2

Lymphocyte to monocyte ratio

Time frame
Measured before and after (24 to 72 hours) surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.