ESPriT2 – a multicentre clinical trial to determine whether surgical removal of superficial peritoneal endometriosis improves pain symptoms and quality of life

ESPriT2 - A multi-centre randomised controlled trial to determine the effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN27244948

Enrollment

400

Registered

2021-04-06

Start date

2021-05-05

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with isolated superficial peritoneal endometriosis Urological and Genital Diseases Endometriosis of pelvic peritoneum

Interventions

Participants will be randomised at time of laparoscopy if superficial peritoneal endometriosis only is found. Randomisation will be to either remove the lesions by excision/ablation/both (depending o

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Aged over 16 2. Undergoing laparoscopy for the investigation of chronic pelvic pain 3. In order to be randomised, isolated superficial peritoneal endometriosis (SPE) must be identified at laparoscopy (macroscopically) 4. Able to give informed consent

Exclusion criteria

Exclusion criteria: 1. Previous surgical diagnosis of endometriosis 2. Pregnant 3. Women who have undergone hysterectomy and or bilateral oophorectomy 4. Deep endometriosis on imaging or at time of laparoscopy 5. Ovarian cyst on imaging that is the indication for surgery 6. Ovarian cyst requiring surgical management at time of laparoscopy 7. Dense adhesions that require surgical management at time of laparoscopy 8. Peritoneal ‘pockets’ only noted at laparoscopy 9. Endometrioma observed at the time of laparoscopy

Design outcomes

Primary

Measure	Time frame
Pain at 12 months post randomisation as defined by the ‘pain domain’ of the EHP-30 questionnaire	—

Secondary

Measure	Time frame
1. Time off work and presenteeism defined by the WPAIQ at 12 months 2. Need for hormonal medication for endometriosis related symptoms at 3, 6 and 12 months 3. Need for analgesics for endometriosis related symptoms at 3, 6 and 12 months 4. Pain domain of the EHP-30 at 3 and 6 months 5. Total score of EHP-30 at 3, 6 and 12 months 6. Fatigue symptoms defined by the BFI at 12 months 7. Neuropathic pain symptoms defined by PainDETECT™ at 12 months 8. Urinary symptoms defined by PUF 12 months 9. Irritable bowel symptoms defined by the ROME IV criteria at 12 months 10. Pain catastrophizing defined by PCQ at 12 months 11. Fibromyalgia defined by FS at 12 months 12. Specific patient reported symptoms defined by MYMOP2 13. Post operative pain and analgesic requirements by patient reported diary 14. Length of hospital stay measured using patient records 15. Surgical complications at 30 days measured using patient records 16. Adverse events related to surgery at 30 days measured using patient records 17. Need for further surgery for endometriosis related symptoms at 12 months measured using patient records 18. Pregnancy events at 3, 6 and 12 months Economic Outcomes 19. Quality of life defined by EQ5D-5L at 3, 6, and 12 months 20. General wellbeing defined by ICECAP-A at 3, 6 and 12 months 21. Costs and resource use at 3, 6 and 12 months (primary and secondary care) collected via a telephone call and completion of a data collection form 22. Impacts on employment, caregiving, and other usual activities (e.g. education) collected via a telephone call and completion of a data collection form	—

Measure

Time frame

1. Time off work and presenteeism defined by the WPAIQ at 12 months 2. Need for hormonal medication for endometriosis related symptoms at 3, 6 and 12 months 3. Need for analgesics for endometriosis related symptoms at 3, 6 and 12 months 4. Pain domain of the EHP-30 at 3 and 6 months 5. Total score of EHP-30 at 3, 6 and 12 months 6. Fatigue symptoms defined by the BFI at 12 months 7. Neuropathic pain symptoms defined by PainDETECT™ at 12 months 8. Urinary symptoms defined by PUF 12 months 9. Irritable bowel symptoms defined by the ROME IV criteria at 12 months 10. Pain catastrophizing defined by PCQ at 12 months 11. Fibromyalgia defined by FS at 12 months 12. Specific patient reported symptoms defined by MYMOP2 13. Post operative pain and analgesic requirements by patient reported diary 14. Length of hospital stay measured using patient records 15. Surgical complications at 30 days measured using patient records 16. Adverse events related to surgery at 30 days measured using patient records 17. Need for further surgery for endometriosis related symptoms at 12 months measured using patient records 18. Pregnancy events at 3, 6 and 12 months Economic Outcomes 19. Quality of life defined by EQ5D-5L at 3, 6, and 12 months 20. General wellbeing defined by ICECAP-A at 3, 6 and 12 months 21. Costs and resource use at 3, 6 and 12 months (primary and secondary care) collected via a telephone call and completion of a data collection form 22. Impacts on employment, caregiving, and other usual activities (e.g. education) collected via a telephone call and completion of a data collection form

—

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactAnn Doust

ann.doust@ed.ac.uk07810643488

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026