D 1205 OULU 2013 D 1205 UNIVERSITY OF OULU P.O.B. 7500 FI-90014 UNIVERSITY OF OULU FINLAND ACTA UNIVERSITATIS OULUENSIS ACTA UNIVERSITATIS OULUENSIS ACTA SERIES EDITORS DMEDICA Sari Ahonkallio ASCIENTIAE RERUM NATURALIUM Sari Ahonkallio Senior Assistant Jorma Arhippainen ENDOMETRIAL THERMAL BHUMANIORA ABLATION University Lecturer Santeri Palviainen CTECHNICA A CHOICE FOR TREATMENT OF HEAVY Docent Hannu Heusala MENSTRUAL BLEEDING DMEDICA Professor Olli Vuolteenaho ESCIENTIAE RERUM SOCIALIUM University Lecturer Hannu Heikkinen FSCRIPTA ACADEMICA Director Sinikka Eskelinen GOECONOMICA Professor Jari Juga EDITOR IN CHIEF Professor Olli Vuolteenaho PUBLICATIONS EDITOR Publications Editor Kirsti Nurkkala UNIVERSITY OF OULU GRADUATE SCHOOL; UNIVERSITY OF OULU, FACULTY OF MEDICINE, ISBN 978-952-62-0142-9 (Paperback) INSTITUTE OF CLINICAL MEDICINE, ISBN 978-952-62-0143-6 (PDF) DEPARTMENT OF OBSTETRICS AND GYNECOLOGY; ISSN 0355-3221 (Print) OULU UNIVERSITY HOSPITAL ISSN 1796-2234 (Online) ACTA UNIVERSITATIS OULUENSIS D Medica 1205 SARI AHONKALLIO ENDOMETRIAL THERMAL ABLATION A choice for treatment of heavy menstrual bleeding Academic dissertation to be presented with the assent of the Doctoral Training Committee of Health and Biosciences of the University of Oulu for public defence in Auditorium 4 of Oulu University Hospital, on 7 June 2013, at 12 noon UNIVERSITY OF OULU, OULU 2013 Copyright © 2013 Acta Univ. Oul. D 1205, 2013 Supervised by Docent Markku Santala Professor Hannu Martikainen Reviewed by Doctor Jyrki Jalkanen Docent Maritta Hippeläinen ISBN 978-952-62-0142-9 (Paperback) ISBN 978-952-62-0143-6 (PDF) ISSN 0355-3221 (Printed) ISSN 1796-2234 (Online) Cover Design Raimo Ahonen JUVENES PRINT TAMPERE 2013 Ahonkallio, Sari, Endometrial thermal ablation. A choice for treatment of heavy menstrual bleeding University of Oulu Graduate School; University of Oulu, Faculty of Medicine, Institute of Clinical Medicine, Department of Obstetrics and Gynecology, P.O. Box 5000, FI-90014 University of Oulu, Finland; Oulu University Hospital, Kajaanintie 50, FI-90220 OYS, Finland Acta Univ. Oul. D 1205, 2013 Oulu, Finland Abstract Heavy menstrual bleeding causes significant health and social problems for up to 30% of women at some point of their lives. Medical treatment is not always sufficient or tolerated by women. Hysterectomy is a definitive solution, but it is a major operation associated with long disability and potential severe complications. Endometrial ablation techniques have been developed to avoid the risks related to hysterectomy. Further evolution of these techniques also offers a possibility of a quick and simple outpatient procedure. This study evaluated the long-term effects of endometrial ablation on heavy menstrual bleeding and later endometrial diagnostics. Another aim was to compare the costs when the procedure was performed in different settings. Finally, the effect of hyaluronic acid gel on intrauterine adhesion formation was assessed. Endometrial ablation had a good long-term effect on heavy menstrual bleeding in a retrospective study of 172 women, and up to 84% avoided hysterectomy during the follow-up time mean of 5 years. Seventy-six per cent of the patients were satisfied with the procedure. Due to the formation of intrauterine adhesions, prior endometrial ablation compromised later diagnostics of endometrium, and outpatient endometrial sampling failed in 23% of 57 women who had undergone endometrial ablation a mean of 6 years earlier, but that did not seem to have clinical importance. In a prospective, randomized and double-blind pilot study of 36 patients, hyaluronic acid gel did not prevent the formation of intrauterine adhesions. In a cost-minimisation analysis based on real resource use, performing endometrial ablation as an outpatient procedure under local anaesthetic instead of a day case procedure performed in the operating theatre under general anaesthetic reduced the costs significantly, from 1,865 to 1,065 euros. In conclusion, the results of this study suggest that endometrial ablation is a good alternative for the treatment of heavy menstrual bleeding, and remarkable cost savings can be achieved by taking the procedure out of the operating theatre. The formation of intrauterine adhesions is common and cannot be prevented with hyaluronic acid gel. Keywords: cost savings, endometrial ablation techniques, menorrhagia, menstruation disturbances, therapy Ahonkallio, Sari, Kohdun limakalvon lämpöhoito. Vaihtoehto runsaiden kuukautisten hoitoon Oulun yliopiston tutkijakoulu; Oulun yliopisto, Lääketieteellinen tiedekunta, Kliinisen lääketieteen laitos, Synnytys ja naistentaudit, PL 5000, 90014 Oulun yliopisto; Oulun yliopistollinen sairaala, Kajaanintie 50, 90220 OYS Acta Univ. Oul. D 1205, 2013 Oulu Tiivistelmä Runsaat kuukautiset aiheuttavat merkittävää terveydellistä ja sosiaalista haittaa jopa kolmasosal- le naisista jossain elämänvaiheessa. Lääkehoito ei aina ole riittävä, eivätkä kaikki naiset voi tai halua käyttää sitä. Kohdunpoisto on lopullinen ratkaisu, mutta se on iso leikkaus, johon liittyy pitkä työkyvyttömyys ja vakavien komplikaatioiden riski. Näiden riskien välttämiseksi on kehi- tetty kohdun limakalvon tuhoavia tekniikoita, joista nykyisin eniten käytetty on limakalvon tuhoaminen lämpöhoidon avulla. Nykytekniikoilla toimenpide voidaan myös tehdä helposti ja nopeasti polikliinisesti. Tässä tutkimuksessa arvioitiin kohdun limakalvon lämpöhoidon pitkäaikaisvaikutuksia run- saiden kuukautisten hoidossa ja sen vaikutusta myöhemmin tapahtuvaan kohdun limakalvon diagnostiikkaan. Niin ikään verrattiin päiväkirurgisen ja polikliinisen toimenpiteen kustannuksia. Lopuksi tutkittiin pystytäänkö hyaluronihappogeelin avulla estämään kohdunsisäisten kiinnik- keiden muodostumista. Lämpöhoidolla oli hyvä pitkäaikaisvaikutus runsaisiin kuukautisiin 172 naista käsittäneessä retrospektiivisessä tutkimuksessa, ja kohdunpoistolta välttyi keskimäärin 5 vuoden seuranta- aikana 84 % naisista. 76 % naisista oli tyytyväisiä hoitoon. Lämpöhoidon aiheuttamat kohdunsisäiset kiinnikkeet vaikeuttivat myöhempää kohdun lima- kalvon diagnostiikkaa. Polikliininen imunäytteen otto ei onnistunut 23 %:lla 57 potilaasta, joille oli tehty lämpöhoito keskimäärin 6 vuotta aikaisemmin. Tällä ei kuitenkaan näyttänyt olevan juurikaan kliinistä merkitystä. 36 potilasta käsittäneessä, prospektiivisessa, satunnaistetussa kak- soissokkotutkimuksessa hyaluronihappogeelin avulla ei pystytty estämään kohdunsisäisten kiin- nikkeiden muodostumista. Todelliseen resurssien käyttöön perustuvassa kustannusten minimointianalyysissa todettiin, että tekemällä lämpöhoito polikliinisesti paikallispuudutuksessa leikkaussalissa nukutuksessa tehtävän toimenpiteen sijasta, kustannukset laskevat 1865 eurosta 1065 euroon. Tämän tutkimuksen perusteella kohdun limakalvon lämpöhoito tarjoaa hyvän vaihtoehdon runsaiden kuukautisten hoitoon, ja sen kustannuksia voidaan merkittävästi pienentää tekemällä toimenpide polikliinisesti. Kohdunsisäisten kiinnikkeiden muodostuminen on tavallista, eikä sitä pystytä estämään hyaluronihappogeelin avulla. Asiasanat: kohdun limakalvon lämpöhoito, kohdun limakalvon poistomenetelmät, kustannussäästöt, kuukautishäiriöt, menorrhagia, runsaat kuukautiset To my beloved ones 8 Acknowledgements This work was carried out at the department of Obstetrics and Gynaecology of the University of Oulu during the years 2005–2013. I wish to express my sincere thanks to Professor Juha Tapanainen, M.D., who was Head of the Department of Obstetrics and Gynaecology for most of that time, for his intelligent and constructive support to my work. Whenever I consulted him, I never left his office empty-handed. I have been privileged to work under the supervision of two tutors whose knowledge and personal properties complement each other. This whole work was initially the idea of docent Markku Santala, who has always been my operative idol, and to whom I owe a debt of gratitude for pretty much all of my skills in that field. Professor Hannu Martikainen was the one who initially introduced me to the world of science, although it took several years before I was mature enough to conduct my own study. I have considered myself extremely lucky to have supervisors with whom there has not been one meeting without humour during these years. I owe a special debt of gratitude to Annikki Liakka, M.D., who has always been so friendly and helpful. With her help I finally understood something about histology. My gratitude goes to Professor Hannu Valtonen from the University of Kuopio for his crucial help in economics. Without his help I would have been totally lost in this area. I want to thank Pirkko Pesonen and Riitta Karjalainen, specialist nurses from the Outpatient Clinic of Gynaecology, who took care of the practical arrangements with such great precision. They never lost their nerves and always looked after practical arrangement. I also want to thank the whole staff in the policlinics, operating theatre and gynaecological ward for an enjoyable co- operation on a daily basis. My special thanks go to my delightful colleagues, who are not only co- workers, but also friends with whom I have the privilege to spend time every day and who have supported me through the tougher days. Laughing with them is the spice of my everyday life. Especially I want to thank Liisa Laatio, M.D., Anna Terho, M.D., Kati Ojala, M.D., Päivi Malmström, M.D., and Sanna Koivunen, M.D., for all the deep conversations concerning life and womanhood. 9 I want to give my warmest thanks to my friend