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.
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 Registration: Netherlands Trial Register (NTR): NTR4029.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4254385 | PMC |
| http://dx.doi.org/10.1186/1472-6874-14-112 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Composite Failure Associated With Sacrohysteropexy and Sacrocolpopexy With Supracervical Hysterectomy for Advanced Pelvic Organ Prolapse.
Neurourol Urodyn
December 2024
Department of Orthopedics, Hokusuikai Kinen Hospital, Ibaraki, Japan.
Objectives: Failures and complications associated with treatments comprising laparoscopic sacrohysteropexy (SHP) for advanced pelvic organ prolapse (POP) are unclear. We compared failure rates associated with SHP and laparoscopic supracervical hysterectomy (SCH)/sacrocolpopexy (SCP) for advanced POP to determine whether they differed.
Methods: Clinical data of patients who underwent SHP (n = 52) and SCH/SCP (n = 209) were retrospectively examined.
Evaluation of the effectiveness of laparoscopic pectopexy in advanced stage apical prolapse.
Eur J Obstet Gynecol Reprod Biol
December 2024
Department of Obstetrics and Gynecology, Kocaeli University, School of Medicine, Kocaeli, Turkey.
Objective: We aimed to investigate the effectiveness of the laparoscopic pectopexy procedure in women who want to preserve their uterus for stage III or IV apical prolapse.
Study Design: 132 women who underwent laparoscopic pectopexy due to stage III or IV apical pelvic organ prolapse (POP) were included in this study. Demographic data of the patients, duration of surgery, blood loss, hospitalisation, intraoperative and postoperative complications, recurrence rate were searched from the hospital file archive.
Long-term follow-up after laparoscopic reparation of pelvic organ prolapses in a large teaching gynecological center.
Eur J Obstet Gynecol Reprod Biol
December 2024
Department of Obstetrics, Gynecology and Assisted Reproduction, Hospital Universitari Dexeus, Barcelona, Spain.
Objective: To provide a description of laparoscopic approach to correct pelvic organ prolapses and evaluate the risk factors associated with the prolapse recurrence.
Study Design: We retrospectively analyzed 418 patients with symptomatic pelvic organ prolapse who underwent a laparoscopic reparation at our university center from 2010 to 2020. Prolapses were assessed by Baden-Walker system (stage I-IV).
Laparoscopic sacrocolpopexy with concurrent hysterectomy or uterine preservation: A metanalysis and systematic review.
Int J Gynaecol Obstet
September 2024
Medical Area Department (DAME), in Department of Medicine (DMED), University of Udine, Udine, Italy.
Background: Literature is lacking strong evidence about comparisons of efficacy and quality of life-related outcomes between laparoscopic total and/or supracervical hysterectomy (LTH/LSCH) with laparoscopic sacrocolpopexy (LSC) and minimally invasive sacrohysteropexy (LSH).
Objective: To summarize and compare available data on this topic providing a useful clinical tool in the treatment decision process.
Search Strategy: We performed a systematic research of PubMed (MEDLINE), Web of Science, and Gooogle Scholar.
Laparoscopic Sacrohysteropexy for the Management of Uterovaginal Prolapse: a Pilot, Single-Center Experience from Saudi Arabia.
Int J Womens Health
September 2024
Department of Obstetrics and Gynecology, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia.
Background: Laparoscopic sacrohysteropexy is an emerging uterine-preserving strategy for management of uterovaginal prolapse (UVP). The literature on laparoscopic sacrohysteropexy for management of UVP is very scarce from Saudi Arabia. This research examined the feasibility, clinical utility, and safety of laparoscopic sacrohysteropexy in a Saudi setting.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!