ESPriT2
Research type
Research Study
Full title
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: ESPriT2
IRAS ID
291525
Contact name
Andrew Horne
Contact email
Sponsor organisation
University of Edinburgh
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
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.
We plan to randomise 400 women from approximately 70 NHS hospitals in the UK over a period of four years. We will approach women who are attending gynaecology departments with pelvic pain who have not previously had a diagnosis of endometriosis via laparoscopy. We will ask the women to read an information sheet about the trial. 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.REC name
East of Scotland Research Ethics Service REC 1
REC reference
20/ES/0127
Date of REC Opinion
20 Jan 2021
REC opinion
Further Information Favourable Opinion