title: Hysteropexy in the treatment of uterine prolapse stage 2 or higher: a multicenter randomized controlled non-inferiority trial comparing laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy (LAVA-trial, study protocol).
abstract: BACKGROUND
  Pelvic organ prolapse is a common health problem: the lifetime risk of undergoing surgery for pelvic organ prolapse by the age of 85 years is 19%. Pelvic organ prolapse has significant negative effects on a woman's quality of life. Worldwide, vaginal hysterectomy is the leading treatment method for patients with symptomatic uterovaginal prolapse. Several studies have shown that vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy are safe and effective alternatives in treating uterine descent. To date, it is unclear which of these techniques leads to the best operative result and the highest patient satisfaction. Therefore, we conducted the LAVA trial.
  
  
  METHODS
  The LAVA trial is a randomized controlled multicenter non-inferiority trial. The study compares laparoscopic sacrohysteropexy with vaginal sacrospinous hysteropexy in women with uterine prolapse stage 2 or higher. The primary outcome of this study is surgical success of the apical compartment at 1 and 5 years follow-up. Secondary outcomes are subjective improvement on urogenital symptoms and quality of life (assessed by disease-specific and general quality of life questionnaires), complications following surgery, hospital stay, post-operative recovery, sexual functioning and costs-effectiveness. Evaluation will take place pre-operatively, and 6 weeks, 6 months, 12 months and annually till 60 months after surgery. Validated questionnaires will be used.Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and a non-inferiority margin of 10%, 62 patients are needed in each arm to prove the hypothesis with a 95% confidence interval.
  
  
  CONCLUSIONS
  The LAVA trial is a randomized controlled multicenter non-inferiority trial that will provide evidence whether the efficacy of laparoscopic sacrohysteropexy is non-inferior to vaginal sacrospinous hysteropexy in women with symptomatic uterine prolapse stage 2 or higher.
  
  
  BACKGROUND
  Netherlands Trial Register (NTR): NTR4029.
authors.affiliation: Department of Obstetrics and Gynecology, Isala Zwolle, PO Box 10500, 8000 GK Zwolle, The Netherlands. m.n.van.ijsselmuiden@isala.nl.
authors.forename: Mèlanie N
authors.initials: MN
authors.lastname: van Ĳsselmuiden
authors.forename: Anne-Lotte W M
authors.initials: AL
authors.lastname: Coolen
authors.forename: Renée J
authors.initials: RJ
authors.lastname: Detollenaere
authors.forename: Jan
authors.initials: J
authors.lastname: den Boon
authors.forename: Marlies
authors.initials: M
authors.lastname: Bongers
authors.forename: Geerte
authors.initials: G
authors.lastname: van de Pol
authors.forename: Astrid
authors.initials: A
authors.lastname: Vollebregt
authors.forename: Celine M
authors.initials: CM
authors.lastname: Radder
authors.forename: Jan
authors.initials: J
authors.lastname: Deprest
authors.forename: Hugo W F
authors.initials: HW
authors.lastname: van Eijndhoven
mesh_terms: D005260:Female; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D010535:Laparoscopy / Q000379:methods; D008022:Ligaments / Q000601:surgery*; D009426:Netherlands; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014596:Uterine Prolapse / Q000601:surgery*; D014599:Uterus / Q000601:surgery*; D014621:Vagina / Q000601:surgery*