DIAMOND

• Research type

  Research Study

• Full title

  Deep infiltrating endometriosis: management by medical treatment versus early surgery: DIAMOND

• IRAS ID

  298771

• Contact name

  Kevin Cooper

• Contact email

  kevin.cooper@nhs.scot

• Sponsor organisation

  University of Aberdeen

• ISRCTN Number

  ISRCTN94462049

• Duration of Study in the UK

  4 years, 3 months, 30 days

• Research summary

  Endometriosis affects 1 in 10 women, and can cause severe pain. It happens when cells similar to those lining the womb grow outside the womb, generally on surfaces and organs within the pelvic cavity, causing bleeding, scarring and inflammation. Occasionally, the endometriosis cells can grow deeper into tissues and organs, such as the bowel, bladder and vagina causing a painful condition called deep endometriosis (DE).

  DE is treated in one of two ways:
  • by taking hormones which can shrink areas of existing endometriosis and prevent new areas forming by stopping the growth of abnormal cells
  • by using keyhole (laparoscopic) surgery to remove areas of endometriosis

  Each treatment has benefits and potential drawbacks. Hormones can produce side effects and are not suitable for women who want to get pregnant. They may also not provide sufficient pain relief in some women who may need to have surgery. Keyhole surgery for DE can reduce pain in many, but not all women, but the procedure is complex with a risk of damage to surrounding organs like blood vessels, bowel and the bladder. There is a lack of evidence about which treatment is best, and the DIAMOND study will help answer this question.

  DIAMOND will compare the benefits and risks of surgery versus medical (hormonal) management as treatment for DE. We will invite women with DE to take part in DIAMOND. Women who agree to take part will have an equal chance of getting hormonal medical treatment or surgery, and we will monitor their symptoms for 18 months via questionnaires every 6 months. Women in either group can also receive additional pain relief and if the medical treatment is not working, they can opt to receive surgery.

• REC name

  West of Scotland REC 4

• REC reference

  21/WS/0136

• Date of REC Opinion

  11 Nov 2021

• REC opinion

  Favourable Opinion