ESPriT2 – a multicentre clinical trial to determine whether surgical removal of superficial peritoneal endometriosis improves pain symptoms and quality of life
| ISRCTN | ISRCTN27244948 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27244948 |
| IRAS number | 291525 |
| Secondary identifying numbers | IRAS 291525 |
- Submission date
- 24/02/2021
- Registration date
- 06/04/2021
- Last edited
- 06/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Endometriosis is a chronic, incurable condition that affects about 10% of women of reproductive age. It is defined as a growth of cells similar to the womb lining outside of the womb in the pelvis, and is associated with chronic pelvic pain,excessive period pain, pain with sexual intercourse and difficulties in getting pregnant. If the disease is found only on the lining of the pelvis it is known as “superficial peritoneal endometriosis” and is usually treated during a laparoscopic surgery by cutting out (excision) or burning off (ablation). However, many women do not find improvement in their symptoms after the surgery and can have complications from the procedure. The aim of this study is to determine if removal of the superficial peritoneal endometriosis improves pain symptoms and quality of life, which method of removal (excision or ablation) is more effective or if surgical removal is of no benefit to the patients and can potentially cause harm.
Who can participate?
Women who are attending gynaecology departments with pelvic pain who have not previously had a diagnosis of endometriosis via laparoscopy.
What does the study involve?
Patients who consent to the trial will be randomised during the surgery, if superficial endometriosis is found, to either having the endometriosis removed or not. Follow-up will be at 30 days, 3, 6 months and 12 month post-operatively. We will also carry out a data linkage follow-up of up to 5 years.
What are the possible benefits and risks of participating?
Participants may or may not get a direct benefit from taking part in this trial. This trial will generate information to allow women with suspected endometriosis and gynaecologists to make an informed choice whether to immediately remove endometriosis when a diagnostic laparoscopy identifies superficial peritoneal endometriosis alone. If the trial shows that removal of superficial peritoneal endometriosis does not help, or makes symptoms worse, this would mean that women could choose to not have it removed or avoid a diagnostic laparoscopy altogether. Women could then opt for early pain management with painkillers, hormones and drugs that work on the nerves in the pelvis.
Where is the study run from?
The trial is being run by Professor Andrew Horne's trial management group in the University of Edinburgh, with database and statistical support from Edinburgh Clinical Trials Unit (UK)
When is the study starting and how long is it expected to run for?
January 2021 to June 2026
Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (UK)
Who is the main contact?
Ann Doust (ann.doust@ed.ac.uk or ETMT@ed.ac.uk)
Contact information
Public
Second Floor Simpson Centre for Reproductive Health
University of Edinburgh
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
 ORCID ID |
0000-0001-8726-7186 |
|---|---|
| Phone | 07810643488 |
| ann.doust@ed.ac.uk |
Study information
| Study design | A multi-centre participant-blind parallel-group randomised controlled clinical and cost effectiveness trial with internal pilot |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | https://www.ed.ac.uk/centre-reproductive-health/ESPriT2 (website under construction) |
| Scientific title | 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 |
| Study acronym | ESPriT2 |
| Study hypothesis | Laparoscopic removal of isolated superficial peritoneal endometriosis is more effective than diagnostic laparoscopy to manage endometriosis-associated pain. |
| Ethics approval(s) | Approved 27/01/2021, East of Scotland Research Ethics Service (Tayside Medical Science Centre, Ninewells Hospital, Dundee, DD1 9SY, UK; +44 (0)1382 383848; tay.eosres@nhs.scot), ref: 20/ES/0127 |
| Condition | Women with isolated superficial peritoneal endometriosis |
| Intervention | 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 on operating surgeon's preference) or to diagnostic laparoscopy alone. Randomisation is via an on-line database and will take place during laparoscopy once eligibility has been confirmed. Follow-up will be at 30 days, 3, 6 months and 12 month post-operatively. We will also carry out a data linkage follow-up of up to 5 years. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain at 12 months post randomisation as defined by the ‘pain domain’ of the EHP-30 questionnaire |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2021 |
| Overall study end date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Female |
| Target number of participants | 400 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 05/05/2021 |
| Recruitment end date | 28/02/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Foresterhill
Aberdeen
AB25 2ZN
United Kingdom
Crosshouse
Kilmarnock
KA2 0BE
United Kingdom
Kirkcaldy
KY2 5AH
United Kingdom
Stirling Road
Larbet
FK5 5WR
United Kingdom
Dudley Road
Birmingham
B18 7QH
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2TG
United Kingdom
Coity Road
Bridgend
CF31 1RQ
United Kingdom
Casterton Avenue
Burnley
BB10 2PQ
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Chester
CH2 1UL
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Raleigh Heights
Barnstaple
EX31 4JB
United Kingdom
Headley Way
Oxford
OX3 9DU
United Kingdom
Derriford Road
PLYMOUTH
PL6 8DH
United Kingdom
Poole
BH15 2JB
United Kingdom
Cosham
Portsmouth
PO6 3LY
United Kingdom
Moorgate Road
Rotherham
S60 2UD
United Kingdom
Treliske
Truro
TR1 3LJ
United Kingdom
Coxford Road
Southampton
SO16 5YA
United Kingdom
Prittlewell Chase
Westcliff-on-Sea
Southend-on-Sea
SS0 0RY
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
South Shields
NE34 0PL
United Kingdom
Aylesbury
HP218AL
United Kingdom
London
SE1 7EH
United Kingdom
Telford
TF1 6TF
United Kingdom
Gynaecology Unit
Lower Ground Floor
EGA Wing
235 Euston Road
London
NW1 2BU
United Kingdom
Moat Road
Walsall
WS2 9PS
United Kingdom
Twickenham Road
Isleworth
London
TW7 6AF
United Kingdom
Higher Kingston
Yeovil
TA19 0BE
United Kingdom
Sponsor information
University/education
ACCORD offices
QMRI
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 3326 |
|---|---|
| resgov@accord.scot | |
| Website | https://www.accord.scot |
"ROR" |
https://ror.org/01nrxwf90 |
Hospital/treatment centre
ACCORD offices
QMRI
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 3326 |
|---|---|
| resgov@accord.scot | |
| Website | http://www.nhslothian.scot.nhs.uk/Pages/default.aspx |
|
"ROR" |
https://ror.org/03q82t418 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The primary academic outputs of the ESPriT2 study will include an HTA monograph and a high-impact open access peer-reviewed journal publication. The trial launch and its results at completion will be disseminated nationally through the BSGE via its SCOPE newsletter (published every three months), which is sent out to all members. Presentations and reports will be submitted to UK specialist bodies with the responsibility of guiding clinical practice, policies, research priorities, governance and training in matters related to pathways of management of women with endometriosis. This will include the Royal College of Obstetricians and Gynaecologists (RCOG) and BSGE. The results of the trial will be included in updates of the NICE guidelines and relevant Cochrane reviews, which directly influence practice in the UK and worldwide respectively. In addition, there will also be a project webpage to be hosted on the Endometriosis UK, EAI and Endometriosis.org websites and the University of Edinburgh website. Professor Vincent will ensure relevant members of the pain community are updated and a summary of the trial at its launch and its findings will be disseminated in the newsletter of the IASP Abdominal and Pelvic Pain SIG and additionally communicated to the British Pain Society for communication to all their members who may work in pelvic pain clinics. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 22/06/2023 | 23/06/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/11/2024: The recruitment end date was changed from 30/11/2024 to 28/02/2025.
06/02/2024: the following changes were made:
1. The overall study end date was changed from 30/06/2025 to 30/06/2026.
2. The recruitment end date was changed from 30/01/2024 to 30/11/2024.
3. The intention to publish date was changed from 30/07/2025 to 30/07/2026.
01/08/2023: The recruitment start date has been changed from 01/04/2021 to 05/05/2021.
23/06/2023: Publication reference added.
02/03/2021: Trial’s existence confirmed by East of Scotland Research Ethics Service.
