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)

Sascha F. M. Schulten*, Rosa A. Enklaar, Kirsten B. Kluivers, Sanne A. L. van Leijsen, Marijke C. Jansen-van der Weide, Eddy M. M. Adang, Jeroen van Bavel, Heleen van Dongen, Maaike B. E. Gerritse, Iris van Gestel, G. G. Alec Malmberg, Ronald J. C. Mouw, Deliana A. van Rumpt-van de Geest, Wilbert A. Spaans, Annemarie van der Steen, Jelle Stekelenburg, E. Stella M. Tiersma, Anneke C. Verkleij-Hagoort, Astrid Vollebregt, Chantal B. M. WingenMirjam Weemhoff, Hugo W. F. van Eijndhoven

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

6 Citations (Web of Science)

Abstract

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 at

Discussion: 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.

Original languageEnglish
Article number49
Number of pages8
JournalBMC Women's Health
Volume19
DOIs
Publication statusPublished - 2 Apr 2019

Keywords

  • Sacrospinous hysteropexy
  • Modified Manchester operation
  • Uterine descent
  • Pelvic organ prolapse
  • POP-Q
  • Reconstructive surgery
  • Randomized clinical trial
  • Cost-utility
  • UTEROSACRAL LIGAMENT SUSPENSION
  • SURGICAL-TREATMENT
  • UTERINE DESCENT
  • HYSTERECTOMY
  • SURGERY
  • PREVALENCE
  • SYMPTOMS
  • RISK

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