Whitaker Lucy H R, Doust Ann, Stephen Jacqueline, Norrie John, Cooper Kevin, Daniels Jane, Hummelshoj Lone, Cox Emma, Beatty Laura, Chien Patrick, Madhra Mayank, Vincent Katy, Horne Andrew W
MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, EH16 4TJ, UK.
Usher Institute, Edinburgh Clinical Trials Unit, University of Edinburgh NINE Edinburgh BioQuarter, Edinburgh, EH16 4UX, UK.
Pilot Feasibility Stud. 2021 Jan 7;7(1):19. doi: 10.1186/s40814-020-00740-9.
Endometriosis (where endometrial-like tissue is found outside the uterus) affects ~ 176 million women worldwide and can lead to debilitating pelvic pain. Three subtypes of endometriosis exist, with ~ 80% of women having superficial peritoneal endometriosis (SPE). Endometriosis is diagnosed by laparoscopy and, if SPE is found, gynaecologists usually remove it surgically. However, many women get limited pain relief from surgical removal of SPE. We plan to undertake a future large trial where women who have only SPE found at initial laparoscopy are randomly allocated to have surgical removal (excision or ablation) of SPE, or not. Ultimately, we want to determine whether surgical removal improves overall symptoms and quality of life, or whether surgery is of no benefit, exacerbates symptoms, or even causes harm. The primary objective of this feasibility study is to determine what proportion of women with suspected SPE undergoing diagnostic laparoscopy will agree to randomisation. The secondary objectives are to determine if there are differences in key prognostic parameters between eligible women that agree to be randomised and those that decline; how many women having laparoscopy for investigation of chronic pelvic pain are eligible for the trial; the range of treatment effects and variability in outcomes and the most acceptable methods of recruitment, randomisation and assessment tools.
We will recruit up to 90 women with suspected SPE undergoing diagnostic laparoscopy over a 9-month recruitment period in four Scottish hospitals and randomise them 1:1 to either diagnostic laparoscopy alone (with a sham port to achieve blinding of the allocation) or surgical removal of endometriosis. Baseline characteristics, e.g. age, index of social deprivation, ethnicity, and intensity/duration of pain will be collected. Participants will be followed up by online questionnaires assessing pain, physical and emotional function at baseline, 3 months, 6 months and 12 months.
Recruitment to a randomised controlled trial to assess the effectiveness of surgery for endometriosis may be challenging because of preconceived ideas about treatment success amongst patients and clinicians. We have designed this study to assess feasibility of recruitment and to inform the design of our future definitive trial.
ClincicalTrials.gov, NCT04081532 STATUS: Recruiting.
子宫内膜异位症（子宫外发现类似子宫内膜的组织）影响着全球约1.76亿女性，可导致使人衰弱的盆腔疼痛。子宫内膜异位症存在三种亚型，约80%的女性患有浅表性腹膜子宫内膜异位症（SPE）。子宫内膜异位症通过腹腔镜检查诊断，如果发现SPE，妇科医生通常会通过手术切除。然而，许多女性通过手术切除SPE后疼痛缓解有限。我们计划在未来进行一项大型试验，将初次腹腔镜检查仅发现SPE的女性随机分为接受SPE手术切除（切除或消融）组或不接受手术切除组。最终，我们想确定手术切除是否能改善总体症状和生活质量，还是手术并无益处、会加重症状甚至造成伤害。这项可行性研究的主要目的是确定接受诊断性腹腔镜检查的疑似SPE女性中同意随机分组的比例。次要目的是确定同意随机分组的合格女性与拒绝随机分组的合格女性在关键预后参数上是否存在差异；有多少因慢性盆腔疼痛接受腹腔镜检查的女性符合试验条件；治疗效果范围、结果变异性以及最可接受的招募、随机分组和评估工具方法。
我们将在9个月的招募期内，在四家苏格兰医院招募多达90名接受诊断性腹腔镜检查的疑似SPE女性，并将她们按1:1随机分为仅接受诊断性腹腔镜检查（带有假端口以实现分配的盲法）组或子宫内膜异位症手术切除组。将收集基线特征，如年龄、社会剥夺指数、种族以及疼痛强度/持续时间。通过在线问卷对参与者在基线、3个月、6个月和12个月时的疼痛、身体和情绪功能进行随访评估。
由于患者和临床医生对治疗成功存在先入为主的观念，招募一项随机对照试验来评估子宫内膜异位症手术的有效性可能具有挑战性。我们设计了这项研究来评估招募的可行性，并为我们未来的确定性试验设计提供信息。
ClinicalTrials.gov，NCT04081532 状态：招募中。
