Trial reportBMC women's health2014
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).
Trial report in BMC women's health, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 16 citations in OpenAlex.
- The Influence of Successful Apical Defect Repair in Laparoscopic Sacrocolpopexy on Quality of Sexual Life.International urogynecology journal · 2026Article
- Sacrospinous hysteropexy versus vaginal hysterectomy with uterosacral ligament suspension in women with uterine prolapse stage 2 or higher: observational follow-up of a multicentre randomised trial.BMJ (Clinical research ed.) · 2019Observational
- Robotic or laparoscopic sacrohysteropexy versus open sacrohysteropexy for uterus preservation in pelvic organ prolapse.International urogynecology journal · 2016Article
- Comparison of the Quality of Life and Female Sexual Function Following Laparoscopic Pectopexy and Laparoscopic Sacrohysteropexy in Apical Prolapse Patients.Gynecology and minimally invasive therapyArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPelvic 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.
methodsThe 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. DISCUSSION: 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.
trial registrationNetherlands Trial Register (NTR): NTR4029.
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