Introduction and Hypothesis <p>Bilateral sacrospinous ligament fixation (BSSLF) is a well-established procedure for apical prolapse repair, yet surgical approaches and outcomes vary. This study presents the first large-cohort, long-term retrospective evaluation of BSSLF using the sling-like mesh Splentis®. We analyse anterior BSSLF (ABSSLF) outcomes without total hysterectomy and compare them with other surgical approaches used in clinical practice.</p> Methods <p>A total of 391 patients treated with Splentis between 2012 and 2023 at two referral centres were stratified into group A (ABSSLF without total hysterectomy, <i>n</i> = 248) and group B (other approaches including posterior fixation and/or total hysterectomy, <i>n</i> = 143). Outcomes were evaluated at intermediate (1–3&#xa0;years, <i>n</i> = 256) and long-term follow-up (&gt; 3&#xa0;years, <i>n</i> = 135). Primary endpoint was composite cure: Pelvic Organ Prolapse Quantification (POP-Q) point C &lt; 0, absence of bulge symptoms and no retreatment. Secondary endpoints included POP-Q changes, patient-reported symptoms and complications.</p> Results <p>Overall cure was 90.3% (95% CI 86.9–93.0%): group A, 94.3% (95% CI 90.7–96.9%); group B, 83.2% (95% CI 76.1–88.9%). Group A remained stable at long-term follow-up, whereas group B declined by 16.2 percentage points. Omission of concomitant anterior colporrhaphy was associated with higher odds of treatment failure (OR 3.0, 95% CI 1.3–6.8; <i>p</i> = 0.010). Most complications were Clavien–Dindo ≤ II. Mesh-related complications were 4.8% (95% CI 2.5–8.3%) in group A and 5.6% (95% CI 2.4–10.7%) in group B.</p> Conclusions <p>The ABSSLF procedure using Splentis showed high long-term effectiveness when used for hysteropexy or cervicopexy, that is, without prior/concomitant total hysterectomy. Other approaches showed lower yet favourable outcomes, highlighting the versatility of the device and the importance of patient selection.</p>

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A Retrospective Cohort Study of Bilateral Sacrospinous Ligament Fixation Over a Decade of Clinical Experience

  • Enrique Ubertazzi,
  • Maria Victoria Lella Gilabert,
  • Hector Soderini,
  • Joaquin Prieto,
  • Lucas Noferi,
  • Juan Sardi

摘要

Introduction and Hypothesis

Bilateral sacrospinous ligament fixation (BSSLF) is a well-established procedure for apical prolapse repair, yet surgical approaches and outcomes vary. This study presents the first large-cohort, long-term retrospective evaluation of BSSLF using the sling-like mesh Splentis®. We analyse anterior BSSLF (ABSSLF) outcomes without total hysterectomy and compare them with other surgical approaches used in clinical practice.

Methods

A total of 391 patients treated with Splentis between 2012 and 2023 at two referral centres were stratified into group A (ABSSLF without total hysterectomy, n = 248) and group B (other approaches including posterior fixation and/or total hysterectomy, n = 143). Outcomes were evaluated at intermediate (1–3 years, n = 256) and long-term follow-up (> 3 years, n = 135). Primary endpoint was composite cure: Pelvic Organ Prolapse Quantification (POP-Q) point C < 0, absence of bulge symptoms and no retreatment. Secondary endpoints included POP-Q changes, patient-reported symptoms and complications.

Results

Overall cure was 90.3% (95% CI 86.9–93.0%): group A, 94.3% (95% CI 90.7–96.9%); group B, 83.2% (95% CI 76.1–88.9%). Group A remained stable at long-term follow-up, whereas group B declined by 16.2 percentage points. Omission of concomitant anterior colporrhaphy was associated with higher odds of treatment failure (OR 3.0, 95% CI 1.3–6.8; p = 0.010). Most complications were Clavien–Dindo ≤ II. Mesh-related complications were 4.8% (95% CI 2.5–8.3%) in group A and 5.6% (95% CI 2.4–10.7%) in group B.

Conclusions

The ABSSLF procedure using Splentis showed high long-term effectiveness when used for hysteropexy or cervicopexy, that is, without prior/concomitant total hysterectomy. Other approaches showed lower yet favourable outcomes, highlighting the versatility of the device and the importance of patient selection.