ESPriT1
Research type
Research Study
Full title
ESPriT1: The effectiveness of laparoscopic treatment of isolated superficial peritoneal endometriosis for managing chronic pelvic pain in women: a randomised controlled feasibility trial
IRAS ID
265594
Contact name
Andrew Horne
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
1 years, 0 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” 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 recruit up to 90 women from four NHS hospitals in Scotland over a period of 12 months. 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. For this pilot, follow up will be at 3 and 6 months (and obtain permission to continue to follow them up at 12 and 24 months should time and finding permit).
Patients who do not consent to take part in the trial will be asked if we can collect data on their demographics and reasons on why they did not wish to take part.REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0079
Date of REC Opinion
16 Jul 2019
REC opinion
Further Information Favourable Opinion