Conventional vaginal approach vs. transvaginal natural orifice transluminal endoscopic surgery for treating apical prolapse, a randomized controlled study.

OBJECTIVE

Vaginal hysterectomy combined with uterosacral suspension (USLS) is a technique for treating pelvic organ prolapse. Vaginal natural orifice transluminal endoscopic surgery (vNOTES) has been described as an alternative minimal invasive approachfor treating various gynecological and non-gynecological pathologies. The aim was to compare the surgical time between conventional vaginal hysterectomy combined with USLS and vNOTES hysterectomy combined with USLS.

STUDY DESIGN

Multi-center randomized controlled trial performed 2019-2021 at Rambam Health Care Campus (Israel) and Imelda Hospital (Belgium). Thirty women underwent vNOTES procedures and 30 women underwent conventional vaginal procedures. The primary outcome was total surgical time. Secondary outcomes included hysterectomy time, USLS time, intraoperative bleeding, length of hospitalization, pain during the first 24 h postoperative, the need of analgesia, intraoperative and postoperative adverse events, and patient-reported outcomes questionnaires. Parametric statistical methods were used to analyze the data.

RESULTS

Compared to conventional vaginal procedures, vNOTES procedures were shorter in total surgical time (77 vs. 93 min, p = 0.004), hysterectomy time (26 vs 33 min, p < 0.001), and USLS time (20 vs 26 min. p = 0.02). Blood loss was higher in conventional vaginal compared to vNOTES surgery, as reflected by the mean blood loss estimate (143 vs 60 ml. p < 0.001) and the delta-hemoglobin (pre-operation minus the post-operation hemoglobin level (1.8 vs 1.2 ml/dL, p = 0.01). There was no difference between the groups regarding analgesics used, postoperative pain, surgical objective outcomes, and scores on patient-reported outcomes questionnaires. Adverse events were significantly more frequent in the conventional vaginal group than in the vNOTES group (p < 0.001 for intraoperative events and p = 0.05 for events that occurred in the follow-up time interval).

CONCLUSION

vNOTES hysterectomy with USLS has lower surgical times than conventional vaginal hysterectomy with USLS, lower blood loss and less adverse events. Other surgical objective and subjective outcomes were similar between the approaches.