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Predicting the Pain Outcome of Surgery for Endometriosis

Sponsor: University of Oxford

NCT ID: NCT07313345

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Surgical treatment of endometriosis (procedure)
How long the study runs
Study runs about 32 months (dates as stated)
About the drug or intervention
Surgical treatment of endometriosis — procedure: This is an observational study and thus the surgery performed is part of standard clinical care.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years to 50 Years
Who
Female
Number of participants
100
Started
2025-12
Last checked
2025-12

Plain English Summary

What is this study?

  • • Testing a new treatment for endometriosis
  • • Clinical study - 100 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 50 Years
  • • Diagnosed with endometriosis
  • • Female only

Where?

  • • Oxford - Oxford University Hospitals Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Endometriosis is a chronic gynaecological condition that affects around 10% of women of reproductive age. This condition can cause debilitating pain, infertility, and poor quality of life. Endometriosis is a condition where tissue resembling the womb lining is present outside of the womb and is associated with an inflammatory pelvic environment. Symptoms of endometriosis can consist of pain during periods, chronic (non-cyclical) pelvic pain, pain during sex, pain when urinating, pain when defecating, and fatigue. Current treatments for endometriosis consist of hormonal, anti-inflammatory and / or analgesic medications and surgery, which is usually laparoscopic ("key-hole"). However, surgery does not always result in a reduction in pain for patients with endometriosis, therefore, it is important to try and understand which patients are most likely to benefit from surgery for their pain management. Endometriosis is categorized into 4 stages (I - IV), ranging from small areas of tissue that do not extend deeply (stage I) to deep lesions associated with significant scarring of the pelvis and ovarian cysts (endometriomas). Interestingly, symptoms do not correlate with stage of disease. An NIHR funded clinical trial is currently investigating whether surgical treatment of superficial peritoneal endometriosis is of clinical benefit (ESPriT2) and is expected to report early in 2026 (recruitment and baseline data collection are complete). However, women with more severe forms of the disease are excluded from this trial. Surgery is commonly recommended for those with more extensive disease (stages III and IV), however, the risks of surgery are considerably greater for these patients including risk of bladder and bowel damage (sometimes requiring stoma formation) and a negative impact on future fertility. Therefore it is important to better understand who will benefit from this type of surgery. Rather than performing a full clinical trial, the investigators will use a set of experimental tests that allow pain to be understood in more detail meaning less people need to be included in the study and results will be available sooner. In the present study, patients with pelvic endometriosis at stage III or IV with planned surgical treatment scheduled will be recruited to the project. Participants taking part will provide data at 5 different time points: Time point 1 will consist of several baseline questionnaires, an experimental sensory assessment, and a brain functional magnetic resonance imaging (fMRI) scan. Time point 2 will be the date of their endometriosis surgery, where a questionnaire will be taken, the surgery will be completed, and several biological samples (e.g. blood and small amounts of pelvic fluid and tissue) will be taken. Time points 3 (3 months post-surgery), 4 (6 months post-surgery), and 5 (12 months post-surgery) will consist of completing online questionnaires. All data collected within this project will be used to investigate pain outcome following endometriosis surgery. This research is funded by NIHR BRC.

Endometriosis

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 50 Years
  • Who can join: Female only

What the study is looking for

  • ✓willing and able to give agreement to take part
  • ✓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)

Who cannot take part

  • ✗pregnant, lactating or planning pregnancy during the course of the study
  • ✗safety concern to MRI
See the full criteria
Inclusion Criteria: * 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 Exclusion Criteria: * pregnant, lactating or planning pregnancy during the course of the study * contraindication to MRI

Where Is This Study? (1 UK site)

Oxford University Hospitals Foundation Trust

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Katy Vincent, DPhil, FRCOGPrincipal Investigator
Christian Becker, MDchristian.becker@wrh.ox.ac.uk

How to Get in Touch

Katy Vincent, DPhil, FRCOG

Sponsor contact

CONTACT

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

Kirralise Hansford, PhD

Sponsor contact

CONTACT

kirralise.hansford@wrh.ox.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-12