TY - JOUR
T1 - Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse
T2 - modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study)
AU - Schulten, Sascha F. M.
AU - Enklaar, Rosa A.
AU - Kluivers, Kirsten B.
AU - van Leijsen, Sanne A. L.
AU - Jansen-van der Weide, Marijke C.
AU - Adang, Eddy M. M.
AU - van Bavel, Jeroen
AU - van Dongen, Heleen
AU - Gerritse, Maaike B. E.
AU - van Gestel, Iris
AU - Malmberg, G. G. Alec
AU - Mouw, Ronald J. C.
AU - van Rumpt-van de Geest, Deliana A.
AU - Spaans, Wilbert A.
AU - van der Steen, Annemarie
AU - Stekelenburg, Jelle
AU - Tiersma, E. Stella M.
AU - Verkleij-Hagoort, Anneke C.
AU - Vollebregt, Astrid
AU - Wingen, Chantal B. M.
AU - Weemhoff, Mirjam
AU - van Eijndhoven, Hugo W. F.
N1 - Funding Information:
This is an investigator initiated trial, the Radboud university medical center is the sponsor (contact information scientific queries: dr. K.B. Kluivers, department of Obstetrics and Gynaecology, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, tel.: + 31 24 3614728). The study received an unrestricted grant from ZonMw, a Dutch organization for Health Research and Development, project number 80–84300–98-83006. ZonMw has no role in the design of the study, collection, analysis, and interpretation of data or writing of the manuscript.
Publisher Copyright:
© 2019 The Author(s).
PY - 2019/4/2
Y1 - 2019/4/2
N2 - Background: 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.Methods: 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 atDiscussion: 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.
AB - Background: 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.Methods: 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 atDiscussion: 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.
KW - Sacrospinous hysteropexy
KW - Modified Manchester operation
KW - Uterine descent
KW - Pelvic organ prolapse
KW - POP-Q
KW - Reconstructive surgery
KW - Randomized clinical trial
KW - Cost-utility
KW - UTEROSACRAL LIGAMENT SUSPENSION
KW - SURGICAL-TREATMENT
KW - UTERINE DESCENT
KW - HYSTERECTOMY
KW - SURGERY
KW - PREVALENCE
KW - SYMPTOMS
KW - RISK
U2 - 10.1186/s12905-019-0749-7
DO - 10.1186/s12905-019-0749-7
M3 - Article
C2 - 30940171
SN - 1472-6874
VL - 19
JO - BMC Women's Health
JF - BMC Women's Health
IS - 1
M1 - 49
ER -