Endometriosis is a chronic inflammatory disease that affects approximately 10-15% of women of reproductive age. Symptoms include dysmenorrhoea, chronic pelvic pain, dyspareunia and infertility. Removal of the endometriotic cyst (chocolate cyst) by surgery is a well-established treatment for symptomatic relief. However, recurrence of endometriotic cyst after surgical removal of the cyst is up to 30-50% after ovarian surgery. Oral contraceptive pills for 18-24 months after the surgery is widely used as a postoperative hormonal therapy because it has been shown to reduce the chance of recurrence of the endometriotic cyst, but recurrence is still high even after taking oral contraceptive pills. Letrozole is an aromatase inhibitor. There are some preliminary reports that letrozole can cause shrinkage of endometriotic cysts and improve endometriosis-related pelvic pain by reducing oestrogen level, inflammation and stem cell recruitment that may be important in recurrence of endometriotic cyst. This is a randomized double-blinded placebo-controlled trial. The aim of this study is to assess whether taking letrozole in addition to oral contraceptive pills in the first 6 months after laparoscopic surgery (key-hole surgery) to remove the endometriotic cyst can reduce the risk of recurrence compared to oral contraceptive pills alone. The study also involves laboratory parts from a small portion of the endometriotic cyst specimens (removed during laparoscopy ovarian cystectomy) and endometrial biopsy (if the patient agrees) to assess the role of stem cells in the pathogenesis of endometriotic cysts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
194
Queen Mary Hospital
Hong Kong, Hong Kong
RECRUITINGKwong Wah Hospital
Hong Kong, Hong Kong
NOT_YET_RECRUITINGPamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
NOT_YET_RECRUITINGPrincess Margaret Hospital
Hong Kong, Hong Kong
NOT_YET_RECRUITINGQueen Elizabeth Hospital
Hong Kong, Hong Kong
NOT_YET_RECRUITINGRecurrence of endometrioma
the presence of ovarian cysts with the typical sonographic criteria of endometriomas and a diameter of ≥30 mm after previous complete ovarian cystectomy, to be measured by a transvaginal or transrectal ultrasound transducer
Time frame: 12 months
Endometriosis Health Profile Questionnaire (EHP-30) score
a validated disease-specific health related quality of life patient self-reported scale for endometriosis used to measure the effects that endometriosis can have on the women's lives and the effectiveness of medical and surgical therapies for endometriosis on their quality of life
Time frame: 6 months, 12 months, 24 months
Non-menstrual pelvic pain (chronic pelvic pain, deep dyspareunia) and dysmenorrhoea measured by a 10cm visual analogue pain scale (VAS)
0-100
Time frame: 6 months, 12 months, 24 months
Menstrual regularity
menstrual chart
Time frame: 6 months, 12 months, 24 months
Use of additional analgesics
Time frame: 6 months, 12 months, 24 months
Side effects/ adverse events
Number of women with side effects/ adverse events
Time frame: 6 months, 12 months, 24 months
Need for further surgery for endometriosis
Number of women who required further surgery for endometriosis
Time frame: 6 months, 12 months, 24 months
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