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
Sponsor organisation
University of Aberdeen
ISRCTN Number
ISRCTN94462049
Duration of Study in the UK
4 years, 3 months, 30 days
Research summary
Summary of Research
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 endometriosisEach 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.
Summary of Results
Endometriosis is a common condition affecting 1 in 10 women, which 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, endometriosis cells can grow deeper into tissues and organs, such as the bowel, bladder and the vagina causing a painful condition called deep endometriosis.Deep endometriosis 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 endometriosisClinical guidelines state that either hormones (medical management) or surgery can be used but are unable to recommend one over the other in the absence of research directly comparing them. As a result, doctors’ decisions are often based on their personal preferences, resulting in major differences in clinical practice across the National Health Service (NHS).
We planned to complete a large UK-wide study (called DIAMOND) to compare the benefits and risks of these treatments for deep endometriosis, to provide a clear and evidence-based answer to this important question. Unfortunately, we found it very difficult to recruit women into DIAMOND. Most women did not join the study because they wanted surgery rather than medical management. Recruitment began in July 2022 and by October 2023 only 18 women had agreed to join the study. Due to the low number of recruited participants, it was decided to stop DIAMOND early. Unfortunately, this means we won’t be able to gather any meaningful results to decide which treatment is best for deep endometriosis.
We hope the difficulties in DIAMOND help inform future studies of treatments for deep endometriosis.
REC name
West of Scotland REC 4
REC reference
21/WS/0136
Date of REC Opinion
11 Nov 2021
REC opinion
Favourable Opinion