Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse: modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study)

Pelvic organ prolapse (POP) affects up to 40% of parous women which adversely affects the quality of life. During a life time, 20% of all women will undergo an operation. In general the guidelines advise a vaginal operation in case of uterine descent: hysterectomy with uterosacral ligament plication (VH), sacrospinous hysteropexy (SSH) or a modified Manchester operation (MM). In the last decade, renewed interest in uterus sparing techniques has been observed. Previous studies have shown non-inferiority between SSH and VH. Whether or not SSH and MM are comparable concerning anatomical and functional outcome is still unknown. The practical application of both operations is at least in The Netherlands a known cause of practice pattern variation (PPV). To reveal any difference between both techniques the SAM-study was designed. The SAM-study is a randomized controlled multicentre non-inferiority study which compares SSH and MM. Women with symptomatic POP in any stage, uterine descent and POP-Quantification (POP-Q) point D at ≤ minus 1 cm are eligible. The primary outcome is the composite outcome at two years of absence of prolapse beyond the hymen in any compartment, the absence of bulge symptoms and absence of reoperation for pelvic organ prolapse. Secondary outcomes are hospital parameters, surgery related morbidity/complications, pain perception, further treatments for prolapse or urinary incontinence, POP-Q anatomy in all compartments, quality-of-life, sexual function, and cost-effectiveness. Follow-up takes place at 6 weeks, 12 and 24 months. Additionally at 12 weeks, 6 and 9 months cost-effectiveness will be assessed. Validated questionnaires will be used and gynaecological examination will be performed. Analysis will be performed following the intention-to-treat and per protocol principle. With a non-inferiority margin of 9% and an expected loss to follow-up of 10%, 424 women will be needed to prove non-inferiority with a confidence interval of 95%. This study will evaluate the effectiveness and costs of SSH versus MM in women with primary POP. The evidence will show whether the existing PPV is detrimental and a de-implementation process regarding one of the operations is needed. Dutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered.

Авторы
Schulten S.F. 1, 2, 3 , Enklaar R.A.1, 4 , Kluivers K.B.1 , Van Leijsen S.A.5 , Jansen-van der Weide M.C.6 , Adang E.M.1 , Van Bavel Jeroen8 , Van Dongen Heleen9 , Gerritse M.B.10 , Van Gestel Iris11 , Malmberg G.G.12 , Mouw R.J.13 , Van Rumpt-van de Geest D.A.14 , Spaans W.A.15 , Van der Steen Annemarie16, 17 , Stekelenburg Jelle18 , Tiersma E.S.6 , Verkleij-Hagoort A.C.19 , Vollebregt Astrid20 , Wingen C.B. , Weemhoff Mirjam4 , Van Eijndhoven H.W.2
Журнал
Издательство
BioMed Central
Номер выпуска
1
Язык
Английский
Страницы
1-8
Статус
Опубликовано
Том
19
Год
2019
Организации
  • 1 Radboud university medical center
  • 2 Department of Obstetrics and Gynaecology, Isala Zwolle
  • 3 Department of Obstetrics and Gynaecology
  • 4 Department of Obstetrics and Gynecology, Zuyderland Medical Center
  • 5 Department of Obstetrics and Gynaecology, Máxima Medical Centre Veldhoven, De Run
  • 6 Amsterdam University Medical Centre, University of Amsterdam
  • 7 Department of Obstetrics and Gynaecology Amphia Hospital
  • 8 Department of Obstetrics and Gynaecology Groene Hart Hospital
  • 9 Department of Obstetrics and Gynaecology Gelderse Vallei Hospital
  • 10 Department of Obstetrics and Gynaecology, Viecuri Hospital
  • 11 University Medical Centre Groningen, University of Groningen
  • 12 Department of Obstetrics and Gynaecology, Rijnstate Hospital
  • 13 Department of Obstetrics and Gynaecology, Reinier de Graaf Hospital
  • 14 Maastricht University Medical Centre
  • 15 Department of Obstetrics and Gynaecology, Ziekenhuisgroep Twente
  • 16 Department of obstetrics and Gynaeology, Medisch Spectrum Twente
  • 17 Department of Obstetrics and Gynaecology, Medical Centre Leeuwarden
  • 18 Department of Obstetrics and Gynaecology, st. Antonius hospital
  • 19 Department of Obstetrics and Gynaecology, Spaarne Gasthuis
  • 20 Department of Obstetrics and Gynaecology, Laurentius Hospital
Ключевые слова
sacrospinous hysteropexy; Modified Manchester operation; Uterine descent; pelvic organ prolapse; POP-Q; reconstructive surgery; randomized clinical trial; cost-utility
Дата создания
10.07.2024
Дата изменения
10.07.2024
Постоянная ссылка
https://repository.rudn.ru/ru/records/article/record/152151/
Поделиться

Другие записи

Fadl Helena, Saeedi Maryam, Montgomery Scott, Magnuson Anders, Schwarcz Erik, Berntorp Kerstin, Sengpiel Verena, Storck-Lindholm Elisabeth, Strevens Helena, Wikström Anna-Karin, Brismar-Wendel Sophia, Persson Martina, Jansson Stefan, Ahlsson Fredrik, Ursing Carina, Ryen Linda, Hildén Karin, Simmons David, Petersson Kerstin, Wennerholm Ulla-Britt
BMC Pregnancy and Childbirth. BioMed Central Ltd. Том 19. 2019. С. 1-11