Intra- and Postoperative Complications in 4565 vNOTES Hysterectomies: International Registry Cohort Study.

Objective: To present the rates of intra- and postoperative complications and conversions in a large cohort of unselected vNOTES hysterectomies, performed by surgeons with different levels of expertise.

Design: International register-based cohort study.

Setting: Hysterectomies in the iNOTESs registry, 2015 to January 2024, performed by 201 surgeons from multiple countries.

Population: 4565 patients undergoing vNOTES hysterectomy.

Methods: Descriptive data are presented in frequencies (n) and percent (%).

Main outcome measure: Intra- and postoperative complications. Conversions.

Results: Intraoperative and postoperative complication rates were 3.2% (n = 144) and 2.5% (n = 115), respectively. Conversions occurred in 1.6% (n = 72), of which 10 (0.2%) to laparotomy, and 82% of the conversions occurred within the first 50 cases of the surgeon's learning curve. The most common intraoperative complication was cystotomy, occurring in 1.3%, and almost half were performed by inexperienced surgeons. Other intraoperative organ injuries occurred in 20 cases (0.44%). Postoperatively, the most common complications were haemorrhage (n = 28), vault complications (n = 26) including 11 infected vault hematomas, cystitis (n = 18) and non-specific infections (n = 14). The vNOTES hysterectomies were performed by 201 surgeons, of which 9.5% had performed more than 50 vNOTES cases, representing 70% of the registered cases in the registry. The remaining 30% of the hysterectomies mainly represent learning curve data from 90% of the included surgeons. The complication rate decreased with increasing surgical experience.

Conclusions: The largest study population of vNOTES hysterectomies is presented, including both learning curve data and data from experienced surgeons, with acceptable rates of intra- and postoperative complications. No implication was found of vNOTES being inferior to other minimally invasive methods.