| Autor: |
Enklaar, Rosa A., Schulten, Sascha F. M., van Eijndhoven, Hugo W. F., Weemhoff, Mirjam, van Leijsen, Sanne A. L., van der Weide, Marijke C., van Bavel, Jeroen, Verkleij-Hagoort, Anna C., Adang, Eddy M. M., Kluivers, Kirsten B. |
| Předmět: |
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| Zdroj: |
JAMA: Journal of the American Medical Association; 8/15/2023, Vol. 330 Issue 7, p626-635, 10p |
| Abstrakt: |
Key Points: Question: Is sacrospinous hysteropexy noninferior to the Manchester procedure for treatment of uterine descent that is not beyond the hymen? Findings: This noninferiority randomized clinical trial included 434 patients with uterine descent that did not protrude beyond the hymen. The composite outcome of success after 2 years was lower for sacrospinous hysteropexy compared with the Manchester procedure (ie, did not meet noninferiority criteria). Meaning: In patients with uterine descent that did not protrude beyond the hymen, the lower composite 2-year outcomes are consistent with inferiority of sacrospinous hysteropexy compared with the Manchester procedure. Importance: In many countries, sacrospinous hysteropexy is the most commonly practiced uterus-preserving technique in women undergoing a first operation for pelvic organ prolapse. However, there are no direct comparisons of outcomes after sacrospinous hysteropexy vs an older technique, the Manchester procedure. Objective: To compare success of sacrospinous hysteropexy vs the Manchester procedure for the surgical treatment of uterine descent. Design, Setting, and Participants: Multicenter, noninferiority randomized clinical trial conducted in 26 hospitals in the Netherlands among 434 adult patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen. Interventions: Participants were randomly assigned to undergo sacrospinous hysteropexy (n = 217) or Manchester procedure (n = 217). Main Outcomes and Measures: The primary outcome was a composite outcome of success, defined as absence of pelvic organ prolapse beyond the hymen in any compartment evaluated by a standardized vaginal support quantification system, absence of bothersome bulge symptoms, and absence of prolapse retreatment (pessary or surgery) within 2 years after the operation. The predefined noninferiority margin was 9%. Secondary outcomes were anatomical and patient-reported outcomes, perioperative parameters, and surgery-related complications. Results: Among 393 participants included in the as-randomized analysis (mean age, 61.7 years [SD, 9.1 years]), 151 of 196 (77.0%) in the sacrospinous hysteropexy group and 172 of 197 (87.3%) in the Manchester procedure group achieved the composite outcome of success. Sacrospinous hysteropexy did not meet the noninferiority criterion of −9% for the lower limit of the CI (risk difference, −10.3%; 95% CI, −17.8% to −2.8%; P =.63 for noninferiority). At 2-year follow-up, perioperative outcomes and patient-reported outcomes did not differ between the 2 groups. Conclusions: Based on the composite outcome of surgical success 2 years after primary uterus-sparing pelvic organ prolapse surgery for uterine descent, these results support a finding that sacrospinous hysteropexy is inferior to the Manchester procedure. Trial Registration: TrialRegister.nl Identifier: NTR 6978 This randomized trial assesses the effect of sacrospinous hysteropexy vs Manchester procedure on a composite outcome of surgical success at 2 years among patients undergoing a first surgical treatment for uterine descent that did not protrude beyond the hymen. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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