EndometrioSis PRediction and Assessment of InflammaTion

NCT07114081 | Completed

• 1 other identifier: 22/PR/0483
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to develop a non-invasive predictive algorithm for a diagnosis of endometriosis in a group of symptomatic women attending for their first laparoscopic surgical procedure for symptoms that are suspicious for pelvic endometriosis and to understand the role of peripheral markers of inflammation in enhancing this diagnosis. The main questions it aims to answer are: Can a non-invasive quantitative algorithm ('Endometriosis Diagnostic Index') accurately predict the presence or absence of pelvic endometriosis? Is the peripheral inflammatory environment (for example, presence of inflammatory cytokines and chemokine) different between people with and without endometriosis?

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Endometriosis predictive model

  Multiple logistic regression model of predictive variables

  24 months

Secondary Outcomes (1)

• Markers of inflammation

  24 months

Interventions

Diagnostic laparoscopy DIAGNOSTIC_TEST

Minimal access surgery to determine the presence of characteristic endometriosis lesions on visual inspection of the pelvis

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive female patients age 18-50 undergoing gynaecological laparoscopic surgery at included institutions

You may qualify if:

• Consecutive female patients age 18-50 undergoing laparoscopy with the suspicion of endometriosis (as indicated by any recording in secondary care medical notes of endometriosis being a possible finding at laparoscopy; all those undergoing laparoscopy for sub-fertility (no conception after ≥6 months of trying, excluding confirmed male factor); or pelvic pain symptoms (dysmenorrhea; non-cyclical pelvic pain; dyspareunia; dyschezia) who is not otherwise excluded.

You may not qualify if:

• previous surgically confirmed endometriosis;
• postmenopausal status;
• laparoscopy for acute indication (ectopic; tubo-ovarian abscess; adnexal torsion);
• suspicion of malignancy;
• the sole indication of tubal sterilisation;
• the sole indication of myomectomy;
• pregnant or breastfeeding;
• significant medical co-morbidities including HIV and/or hepatitis B or C infection;
• where gynaecology is not the primary team undertaking surgery;
• unable to have transvaginal ultrasound (TVUSS);
• declines to take part in the study;
• patient unable to understand verbal or written information in English;
• lack of capacity to consent at the point of recruitment;
• known safeguarding issues.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Chelsea and Westminster Hospital NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 11, 2025
• Study Start: July 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: August 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)