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临床试验/NCT07313345
NCT07313345招募中不适用

Predicting the Pain Outcome of Surgery for Endometriosis

University of Oxford1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Brain response to punctate stimulation of the calf

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Brain response to punctate stimulation of the calf

时间窗: prior to surgery

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.

次要结局

  • Brain connectivity at rest(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)
  • Brain volume(prior to surgery)
  • Neuropathic-like pain(prior to surgery)
  • Pain catastrophising(Prior to surgery)
  • Pain self-efficacy(Prior to surgery)
  • Expectation of surgical efficacy(Prior to surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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