NOTES sacrocolpopexy versus sacrospinous ligament fixation for apical pelvic organ prolapse: a pilot, hypothesis-generating, single-centre retrospective comparative cohort study.

BACKGROUND

To compare anatomical, functional, and safety outcomes of vaginal natural orifice transluminal endoscopic surgery (vNOTES) sacrocolpopexy (SCP) and vNOTES sacrospinous ligament fixation (SSLF) for apical pelvic organ prolapse (POP).

METHODS

Single-centre, single-surgeon, retrospective comparative cohort study conducted in accordance with the STROBE statement. Allocation to vNOTES SSLF (n = 24) or vNOTES SCP with a lightweight polypropylene Y-mesh (n = 32) was based on prespecified intra-operative feasibility criteria rather than randomisation. The primary outcome was composite apical anatomical success at 12 months (point C ≤ -5 cm and absence of apical POP-Q stage ≥ II). Secondary outcomes included perioperative parameters, visual analogue scale (VAS) pain scores, Quality-of-Recovery-40 (QoR-40), Prolapse Quality-of-Life (P-QOL), ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form) and PGI-I scores, and complications classified with the Clavien-Dindo and IUGA/ICS Category-Time-Site systems.

RESULTS

Baseline characteristics were balanced. Composite apical success at 12 months was achieved in 22/24 (91.7%) SSLF patients and 30/32 (93.8%) SCP patients (risk difference -2.1 percentage points; 95% CI, -17.6 to +13.5); this interval is compatible with clinically meaningful differences in either direction and does not support an inference of equivalence. Suspension time was shorter with SSLF (40.2 ± 11.8 vs 54.6 ± 12.7 min; p < 0.001), as was total operative time (89.7 ± 15.2 vs 104.9 ± 17.6 min; p = 0.001). Estimated blood loss, VAS pain, QoR-40, P-QOL, ICIQ-UI SF and PGI-I showed no statistically detectable difference. No intra-operative injuries, conversions to laparotomy, or mesh-related events (IUGA/ICS classification) were detected during a median follow-up of 21 months (range 6-36) for SSLF and 20 months (8-35) for SCP.

CONCLUSIONS

In this hypothesis-generating single-surgeon cohort, vNOTES SSLF and vNOTES SCP showed no statistically detectable difference in short- to mid-term anatomical and patient-reported outcomes, with shorter suspension time favouring SSLF.