Controversies in the Management of Endometrioma

Johnstone, Erica; Link, M

doi:10.1097/grf.0000000000000151

Cited by 8 publications

(2 citation statements)

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“…The best treatment for ovarian endometrioma-related pain symptoms is unknown and this has been prioritised as a knowledge gap by NVOG and the ESHRE Guideline Development Group ( NVOG 2016 ; Dunselman et al, 2014 ). A review from Johnstone and Link et al . (2015) included articles describing the effectiveness of hormonal therapy and surgery in patients with an ovarian endometrioma.…”

Section: Discussionmentioning

confidence: 99%

SOMA-trial: surgery or medication for women with an endometrioma? Study protocol for a randomised controlled trial and cohort study

Barneveld

Veth

Sampat

et al. 2020

Human Reproduction Open

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STUDY QUESTIONS The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an ovarian endometrioma when compared to treatment with medication (analgesia and/or hormones). The primary outcome is defined as successful pain reduction (−30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life, affective symptoms, cost-effectiveness, recurrence rate, need of adjuvant medication after surgery, ovarian reserve, adjuvant surgery and budget impact. WHAT IS KNOWN ALREADY Evidence suggests that both medication and surgical treatment of an ovarian endometrioma are effective in reducing pain and improving quality of life. However, there are no randomised studies that compare surgery to treatment with medication. STUDY DESIGN, SIZE, DURATION This study will be performed in a research network of university and teaching hospitals in the Netherlands. A multicentre randomised controlled trial and parallel prospective cohort study in patients with an ovarian endometrioma, with the exclusion of patients with deep endometriosis, will be conducted. After obtaining informed consent, eligible patients will be randomly allocated to either treatment arm (medication or surgery) by using web-based block randomisation stratified per centre. A successful pain reduction is set at a 30% decrease on the NRS at 6 months after randomisation. Based on a power of 80% and an alpha of 5% and using a continuity correction, a sample size of 69 patients in each treatment arm is needed. Accounting for a drop-out rate of 25% (i.e. loss to follow up), we need to include 92 patients in each treatment arm, i.e. 184 in total. Simultaneously, a cohort study will be performed for eligible patients who are not willing to be randomised because of a distinct preference for one of the two treatment arms. We intend to include 100 women in each treatment arm to enable standardization by inverse probability weighting, which means 200 patients in total. The expected inclusion period is 24 months with a follow-up of 18 months. PARTICIPANTS/MATERIALS, SETTING, METHODS Premenopausal women (age ≥ 18 years) with pain (dysmenorrhoea, pelvic pain or dyspareunia) and an ovarian endometrioma (cyst diameter ≥ 3 cm) who visit the outpatient clinic will make up the study population. Patients with signs of deep endometriosis will be excluded. The primary outcome is successful pain reduction, which is defined as a 30% decrease of pain on the NRS at 6 months after randomisation. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life and affective symptoms, cost-effectiveness (from a healthcare and societal perspective), number of participants needing additional surgery, need of adjuvant medication after surgery, ovarian reserve and recurrence rate of endometriomas. Measurements will be performed at baseline, 6 weeks and 6, 12 and 18 months after randomisation. STUDY FUNDING/COMPETING INTEREST(S) This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-85200-98-91041. The Department of Reproductive Medicine of the Amsterdam UMC location VUmc has received several research and educational grants from Guerbet, Merck KGaA and Ferring not related to the submitted work. B.W.J. Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for ObsEva, Merck KGaA and Guerbet. V. Mijatovic reports grants from Guerbet, grants from Merck and grants from Ferring outside the submitted work. All authors declare that they have no competing interests concerning this publication. TRIAL REGISTRATION NUMBER Dutch Trial Register (NTR 7447, http://www.trialregister.nl). TRIAL REGISTRATION DATE 2 January 2019 DATE OF FIRST PATIENT’S ENROLMENT First inclusion in randomised controlled trial October 4, 2019. First inclusion in cohort May 22, 2019.

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Section: Discussionmentioning

confidence: 99%

SOMA-trial: surgery or medication for women with an endometrioma? Study protocol for a randomised controlled trial and cohort study

Barneveld

Veth

Sampat

et al. 2020

Human Reproduction Open

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“…Hormonal treatment of endometriomas may be associated with cyst size reduction and symptom improvement but is unlikely to impart cyst resolution. [32][33][34][35][36][37] A recent meta-analysis has comprehensively reviewed the effect of medical management on ovarian endometrioma size and concluded that dienogest, oral contraceptive pills, gonadotropin-releasing hormone agonists, norethindrone acetate, and danazol have all been shown to reduce cyst diameter by a mean of 0.6-1.95 cm, with oral contraceptive pills having been studied most extensively and danazol showing the largest mean reduction in cyst size. 38 Medical management alone foregoes the opportunity for histologic diagnosis, and surgery is generally preferred for both diagnosis and treatment.…”

Section: Medical Managementmentioning

confidence: 99%

Pathophysiology and Clinical Implications of Ovarian Endometriomas

Nezhat,

Cathcart,

Nezhat

et al. 2024

Obstetrics &Amp; Gynecology

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Ovarian endometriomas affect many patients with endometriosis and have significant effects on quality of life, fertility, and risk of malignancy. Endometriomas range from small (1–3 cm), densely fibrotic cysts to large (20 cm or greater) cysts with varying degrees of fibrosis. Endometriomas are hypothesized to form from endometriotic invasion or metaplasia of functional cysts or alternatively from ovarian surface endometriosis that bleeds into the ovarian cortex. Different mechanisms of endometrioma formation may help explain the phenotypic variability observed among endometriomas. Laparoscopic surgery is the preferred first-line modality of diagnosis and treatment of endometriomas. Ovarian cystectomy is preferred over cyst ablation or sclerotherapy for enabling pathologic diagnosis, improving symptoms, preventing recurrence, and optimizing fertility outcomes. Cystectomy for small, densely adherent endometriomas is made challenging by dense fibrosis of the cyst capsule obliterating the plane with normal ovarian cortex, whereas cystectomy for large endometriomas can carry unique challenges as a result of adhesions between the cyst and pelvic structures. Preoperative and postoperative hormonal suppression can improve operative outcomes and decrease the risk of endometrioma recurrence. Whether the optimal management, fertility consequences, and malignant potential of endometriomas vary on the basis of size and phenotype remains to be fully explored.

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