Characteristics associated with composite surgical failure over 5 years of women in a randomized trial of sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral ligament suspension.
sacrospinous hysteropexy with graft
surgical repair
transvaginal mesh hysteropexy
transvaginal prolapse repair
uterosacral ligament suspension
uterovaginal prolapse
vaginal hysterectomy
Journal
American journal of obstetrics and gynecology
ISSN: 1097-6868
Titre abrégé: Am J Obstet Gynecol
Pays: United States
ID NLM: 0370476
Informations de publication
Date de publication:
01 2023
01 2023
Historique:
received:
14
04
2022
revised:
19
07
2022
accepted:
26
07
2022
pmc-release:
01
01
2024
pubmed:
6
8
2022
medline:
28
12
2022
entrez:
5
8
2022
Statut:
ppublish
Résumé
Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the Vaginal hysterectomy with Native Tissue Vault Suspension vs Sacrospinous Hysteropexy with Graft Suspension (Study for Uterine Prolapse Procedures Randomized Trial) trial, sacrospinous hysteropexy with graft (hysteropexy) resulted in a lower composite surgical failure rate than vaginal hysterectomy with uterosacral suspension over 5 years. This study aimed to identify factors associated with the rate of surgical failure over 5 years among women undergoing sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral suspension for uterovaginal prolapse. This planned secondary analysis of a comparative effectiveness trial of 2 transvaginal apical suspensions (NCT01802281) defined surgical failure as either retreatment of prolapse, recurrence of prolapse beyond the hymen, or bothersome prolapse symptoms. Baseline clinical and sociodemographic factors for eligible participants receiving the randomized surgery (N=173) were compared across categories of failure (≤1 year, >1 year, and no failure) with rank-based tests. Factors with adequate prevalence and clinical relevance were assessed for minimally adjusted bivariate associations using piecewise exponential survival models adjusting for randomized apical repair and clinical site. The multivariable model included factors with bivariate P<.2, additional clinically important variables, apical repair, and clinical site. Backward selection determined final retained risk factors (P<.1) with statistical significance evaluated by Bonferroni correction (P<.005). Final factors were assessed for interaction with type of apical repair at P<.1. Association is presented by adjusted hazard ratios and further illustrated by categorization of risk factors. In the final multivariable model, body mass index (increase of 5 kg/m Obesity and duration of prolapse symptoms have been determined as risk factors associated with surgical failure over 5 years from transvaginal prolapse repair, regardless of approach. Providers and patients should consider these modifiable risk factors when discussing treatment plans for bothersome prolapse.
Sections du résumé
BACKGROUND
Among women with symptomatic uterovaginal prolapse undergoing vaginal surgery in the Vaginal hysterectomy with Native Tissue Vault Suspension vs Sacrospinous Hysteropexy with Graft Suspension (Study for Uterine Prolapse Procedures Randomized Trial) trial, sacrospinous hysteropexy with graft (hysteropexy) resulted in a lower composite surgical failure rate than vaginal hysterectomy with uterosacral suspension over 5 years.
OBJECTIVE
This study aimed to identify factors associated with the rate of surgical failure over 5 years among women undergoing sacrospinous hysteropexy with graft vs vaginal hysterectomy with uterosacral suspension for uterovaginal prolapse.
STUDY DESIGN
This planned secondary analysis of a comparative effectiveness trial of 2 transvaginal apical suspensions (NCT01802281) defined surgical failure as either retreatment of prolapse, recurrence of prolapse beyond the hymen, or bothersome prolapse symptoms. Baseline clinical and sociodemographic factors for eligible participants receiving the randomized surgery (N=173) were compared across categories of failure (≤1 year, >1 year, and no failure) with rank-based tests. Factors with adequate prevalence and clinical relevance were assessed for minimally adjusted bivariate associations using piecewise exponential survival models adjusting for randomized apical repair and clinical site. The multivariable model included factors with bivariate P<.2, additional clinically important variables, apical repair, and clinical site. Backward selection determined final retained risk factors (P<.1) with statistical significance evaluated by Bonferroni correction (P<.005). Final factors were assessed for interaction with type of apical repair at P<.1. Association is presented by adjusted hazard ratios and further illustrated by categorization of risk factors.
RESULTS
In the final multivariable model, body mass index (increase of 5 kg/m
CONCLUSION
Obesity and duration of prolapse symptoms have been determined as risk factors associated with surgical failure over 5 years from transvaginal prolapse repair, regardless of approach. Providers and patients should consider these modifiable risk factors when discussing treatment plans for bothersome prolapse.
Identifiants
pubmed: 35931131
pii: S0002-9378(22)00619-6
doi: 10.1016/j.ajog.2022.07.048
pmc: PMC9790026
mid: NIHMS1834810
pii:
doi:
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
63.e1-63.e16Subventions
Organisme : NICHD NIH HHS
ID : U10 HD054215
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD069010
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD069006
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD069010
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD069013
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD041267
Pays : United States
Organisme : NICHD NIH HHS
ID : U01 HD069031
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD069025
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD041261
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD054214
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD041267
Pays : United States
Organisme : NICHD NIH HHS
ID : UG1 HD054214
Pays : United States
Organisme : NICHD NIH HHS
ID : U10 HD069006
Pays : United States
Informations de copyright
Copyright © 2022 Elsevier Inc. All rights reserved.
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