Hysteropexy in the treatment of uterine prolapse stage 2 or higher: laparoscopic sacrohysteropexy versus sacrospinous hysteropexy—a multicentre randomised controlled trial (LAVA trial)

Objective To investigate whether laparoscopic sacrohysteropexy (LSH) is non‐inferior to vaginal sacrospinous hysteropexy (SSHP) in the surgical treatment of uterine prolapse. Design Multicentre randomised controlled, non‐blinded non‐inferiority trial. Setting Five non‐university teaching hospitals i...

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Bibliographic Details
Published in:BJOG : an international journal of obstetrics and gynaecology 2020-09, Vol.127 (10), p.1284-1293
Main Authors: IJsselmuiden, MN, Oudheusden, AMJ, Veen, J, Pol, G, Vollebregt, A, Radder, CM, Housmans, S, Kuijk, SMJ, Deprest, J, Bongers, MY, Eijndhoven, HWF
Format: Article
Language:English
Subjects:
Aged
Apical prolapse
Fecal incontinence
Female
Gynecologic Surgical Procedures - adverse effects
Gynecologic Surgical Procedures - methods
Humans
hysteropexy
laparoscopic
Laparoscopy
Laparoscopy - adverse effects
Laparoscopy - methods
mesh
Middle Aged
Quality of life
Recurrence
Severity of Illness Index
Surgery
Treatment Outcome
uterine prolapse
Uterine Prolapse - classification
Uterine Prolapse - surgery
uterine suspension
Uterus
Vagina
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Summary:Objective To investigate whether laparoscopic sacrohysteropexy (LSH) is non‐inferior to vaginal sacrospinous hysteropexy (SSHP) in the surgical treatment of uterine prolapse. Design Multicentre randomised controlled, non‐blinded non‐inferiority trial. Setting Five non‐university teaching hospitals in the Netherlands, one university hospital in Belgium. Population 126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery. Methods Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse. The predefined inferiority margin was an increase in surgical failure rate of 10%. Main outcome measures Primary outcome was surgical failure, defined as recurrence of uterine prolapse (POP‐Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperatively. Secondary outcomes were anatomical recurrence (any compartment), functional outcome and quality of life. Results Laparoscopic sacrohysteropexy was non‐inferior for surgical failure (n = 1, 1.6%) compared with SSHP (n = 2, 3.3%, difference −1.7%, 95% CI: −7.1 to 3.7) 12 months postoperatively. Overall, anatomical recurrences and quality of life did not differ. More bothersome symptoms of overactive bladder (OAB) and faecal incontinence were reported after LSH. Dyspareunia was more frequently reported after SSHP. Conclusion Laparoscopic sacrohysteropexy was non‐inferior to SSHP for surgical failure of the apical compartment at 12 months’ follow up. Following LSH, bothersome OAB and faecal incontinence were more frequent, but dyspareunia was less frequent. Tweetable Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short‐term outcomes. Tweetable Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short‐term outcomes.
ISSN:1470-0328
1471-0528
DOI:10.1111/1471-0528.16242