Predicting the Pain Outcome of Surgery for Endometriosis

NCT07313345 | Recruiting

• 1 other identifier: PrePOSE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether the investigators can predict who will get benefit in terms of their pain from surgery for more severe forms of endometriosis. The investigators will use brain imaging to explore this, as it allows meaningful results from a smaller sample of people than if questionnaires alone were relied on.

Conditions

Endometriosis

Keywords

pelvic pain; fMRI; PROMs

Outcome Measures

Primary Outcomes (1)

• Brain response to punctate stimulation of the calf

  BOLD (Blood oxygen level dependent) response measured with fMRI. Analysis will determine whether BOLD response prior to surgery can predict the pain response (at 12 months post-surgery) to surgical treatment of severe endometriosis.

  prior to surgery

Secondary Outcomes (8)

• Brain connectivity at rest

  prior to surgery

• Brain volume

  prior to surgery

• Non-cyclical pelvic pain measured on an 11 point numerical rating scale (NRS)

  prior to surgery and at 12 months post-surgery

• Pain widespreadness

  Prior to surgery

• Neuropathic-like pain

  prior to surgery

Other Outcomes (1)

• Quantitative Sensory Testing (QST) of the lower abdomen and left hand according to the German Neuropathic Pain Network Protocol

  Prior to surgery

Study Arms (1)

PrePOSE cohort

Women aged 18 - 50 years, with stage III or IV endometriosis, reporting pelvic pain of ≥4/10 and planned for surgical treatment of their endometriosis

Procedure: Surgical treatment of endometriosis

Interventions

Surgical treatment of endometriosis PROCEDURE

This is an observational study and thus the surgery performed is part of standard clinical care. The procedure will be at the discretion of the operating surgeon/endometriosis multi-disciplinary team and may include bowel resection, stoma formation, ureteric stenting/reimplantation, salpingectomy, oophorectomy or hysterectomy in addition to excision/ablation of endometriosis lesions. Information about the surgical procedure will be collected, but no planned surgical procedure will be an exclusion.

PrePOSE cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients on the waiting list for surgery for severe endometriosis at the Oxford University Hospitals NHS Trust

You may qualify if:

• willing and able to give informed consent
• aged between 18 and 50 years of age
• female or born female
• diagnosed with stage III or IV endometriosis by scan (MRI or USS) or previous surgery
• surgical treatment of severe endometriosis planned (surgical procedure at discretion of operating surgeon)
• reports pelvic pain of ≥4/10 (measured using a 0 - 10 numerical rating scale asking about the participant's worst pelvic pain associated with their endometriosis)
• reasonably fluent in English
• in the Investigator's opinion, is able and willing to comply with all study requirements
• willing to allow his or her General Practitioner and consultant to be notified of participation in the study

You may not qualify if:

• pregnant, lactating or planning pregnancy during the course of the study
• contraindication to MRI

Sponsors & Collaborators

• Endometriosis UK: collaborator
• University of Oxford: lead

Study Sites (1)

Oxford University Hospitals Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, peritoneal fluid, peritoneum, endometriosis samples (ectopic endometrium and endometrioma)

MeSH Terms

Conditions

Endometriosis; Pelvic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katy Vincent

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katy Vincent, DPhil, FRCOG

CONTACT

00 44 1865 220024; katy.vincent@wrh.ox.ac.uk

Kirralise Hansford, PhD

CONTACT

kirralise.hansford@wrh.ox.ac.uk

Study Design

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

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 31, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of all manuscripts from the study
• Access Criteria: Data will be publicly accessible

Locations

GB (1)