REGAL trial

Recurrence of endometriosis: GnRH analogues versus laparoscopic surgery (REGAL) trial

Endometriosis is a common, painful condition affecting one in ten women of childbearing age. It occurs when cells like those lining the womb grow outside it, causing internal bleeding, scarring and pain. Key hole surgery (laparoscopy) is commonly used to destroy areas of endometriosis. However, endometriosis returns in up to half of treated women within five years, and there is uncertainty about how best to treat women, particularly those who wish to preserve their fertility. Repeat surgery is invasive, expensive and risky, without guaranteeing a cure. A less invasive treatment is monthly or three-monthly injections with Gonadotrophin Releasing hormone (GnRH) analogues. While effective in reducing pain, this type of hormonal treatment has generally only been used for up to a year because of the risk of side effects (hot flushes and night sweats) and concerns about osteoporosis. However, recent research suggests that giving small doses of hormone replacement therapy (HRT) with GnRH analogues can reduce the risk of side effects. Funded by the National Institute for Health Research (NIHR), this trial will assess the clinical and cost-effectiveness of long-term GnRH analogues with added HRT compared to conservative key hole surgery in women who experience recurrence of pain after surgery but who wish to preserve their fertility.

HERU researchers involved in this research project: Graham Scotland

External collaborators: Saraswat, L. (NHS Grampian & University of Aberdeen); MacLennan, G., Gillies, K. (Health Services Research Unit (HSRU), University of Aberdeen); Bhattacharya, S. (Other Applied Health Sciences, University of Aberdeen).