Endometriosis affects up to 10% of women of reproductive age, significantly impairing quality of life, affecting work, relationships and education. Deep endometriosis is its most severe form but there is uncertainty as to what is the most effective and efficient treatment. NICE and the European Society for Human Reproduction and Embryology suggest both medical and surgical treatments can be used for deep endometriosis but highlight the lack of evidence to guide practice and the need for a large, multi-centre RCT.
DIAMOND is a major UK multi-centre NIHR HTA funded RCT to compare early planned laparoscopic surgery (with or without adjuvant medical treatment) versus medical management alone in women with deep endometriosis. We aim to recruit 400 women, aged 18-49, with confirmed deep endometriosis, seeking treatment for pain, who are suitable for either surgical or medical management, within BSGE accredited UK endometriosis centres.
Consenting women will be randomised to receive either laparoscopic surgery (with or without adjuvant medical treatment) or hormonal treatment (with or without neuromodulator or analgesics) for 18 months. Surgery will involve division of dense adhesions to separate affected pelvic structures, restore normal anatomy and removal of all endometriotic deposits, including deep nodules. The choice of hormonal medication will be at the discretion of the treating clinician in discussion with the participating woman and local policy.
Patient reported outcomes will be collected by postal/email questionnaire at 6 weeks after receiving surgery/hormonal treatment and at 12 and 18 months after randomisation. Data on further treatment will also be captured at 18 months from a clinic review of medical records.
The primary outcome is the pain domain of the condition-specific Endometriosis Health Profile-30 (EHP-30) and the incremental cost per quality adjusted life years gained, measured at 18 months after randomisation. Secondary outcomes include complications, serious adverse events, satisfaction, pain, further treatment/surgery and reproductive outcomes.
DIAMOND is led by Professors Kevin Cooper (Aberdeen Royal Infirmary) and T Justin Clark (Birmingham Women’s NHS Foundation Trust)
For more information, please see the DIAMONDÂ study website.
Contacts
- Lynda Constable; l.constable@abdn.ac.uk