Vaginal natural orifice transluminal endoscopic surgery vs. single port assess for hysterectomy: a randomized pilot study (VANILLA trial)

Introduction: Vaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy has shown benefit in postoperative pain and operation time compared to laparoscopic hysterectomy in recent studies. However, no prospective studies comparing laparoendoscopic single-site (LESS) and vNOTES hysterectomy have been performed. This study aims to evaluate postoperative pain and safety of vNOTES hysterectomy compared to LESS hysterectomy for benign uterine disease. Methods: This study is a prospective, investigator-initiated randomized controlled pilot trial. A total of 26 patients were randomized and allocated to vNOTES group (n = 13) and LESS group (n = 13). The primary outcome was postoperative abdominal and vaginal pain evaluated 24 h after surgery. Secondary outcomes included the number of additional analgesics administered and the maintenance rate of patient-controlled analgesia (PCA). Results: No differences were shown in baseline characteristics between the two groups. Operation time was longer in the LESS group (median, 55 vs. 75 min; P = 0.027), and there were no differences in estimated blood loss, postoperative hemoglobin level, surgical indications, and hospitalization days. Postoperative abdominal pain intensity did not differ between the two groups, while the vNOTES group showed higher postoperative vaginal pain than the LESS group at 16 and 24 h after surgery (median, 3 vs. 1 and 2 vs. 0, P = 0.007 and P = 0.010, at 16 and 24 h respectively). No differences were shown in the number of additional analgesics and PCA use between the two groups. Conclusions: vNOTES hysterectomy can be safely performed for benign uterine disease requiring hysterectomy. However, vNOTES hysterectomy might be associated with higher postoperative vaginal pain intensity compared to LESS hysterectomy.