Laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women: study protocol for a randomised controlled feasibility trial (ESPriT1)

Lucy H R Whitaker, Ann Doust, Jacqueline Stephen, John Norrie, Kevin Cooper, Jane Daniels, Lone Hummelshoj, Emma Cox, Laura Beatty, Patrick Chien, Mayank Madhra, Katy Vincent, Andrew W Horne, Lucy H R Whitaker, Ann Doust, Jacqueline Stephen, John Norrie, Kevin Cooper, Jane Daniels, Lone Hummelshoj, Emma Cox, Laura Beatty, Patrick Chien, Mayank Madhra, Katy Vincent, Andrew W Horne

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: ClincicalTrials.gov, NCT04081532 STATUS: Recruiting.

Keywords: Ablation; Chronic pelvic pain; Excision; Feasibility trial; Placebo; Surgery.

Conflict of interest statement

Andrew Horne receives grant funding from the NIHR, MRC, Chief Scientist’s Office, Wellcome Trust, Wellbeing of Women, Ferring and Roche. He has received honoraria for consultancy for Ferring, Roche Diagnostics, Nordic Pharma and Abbvie. Lone Hummelshoj has received honoraria for advice to AbbVie. The remaining authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow chart for the trial process

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