Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day‐care procedure: a randomised controlled trial

Abstract

Objective To compare hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) versus total laparoscopic hysterectomy (TLH) as a day-care procedure.Design Parallel group, 1:1 randomised single-centre single-blinded trial, designed as a non-inferiority study with a margin of 15%.Setting Belgian teaching hospital.Population Women aged 18-70 years scheduled to undergo hysterectomy for benign indications.Methods Randomisation to TLH (control group) or vNOTES (experimental group). Stratification according to uterine volume. Blinding of participants and outcome assessors.Main outcome measures The primary outcome was hysterectomy by the allocated technique. We measured the proportion of women leaving within 12 hours after hysterectomy and the length of hospital stay as secondary outcomes. Results We randomly assigned 70 women to vNOTES (n = 35) or TLH (n = 35). The primary endpoint was always reached in both groups: there were no conversions. We performed a sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the TLH group: the onesided 95% upper limit for the differences in proportions of conversion was estimated as 7.5%, which is below the predefined non-inferiority margin. More women left the hospital within 12 hours after surgery after vNOTES: 77 versus 43%, difference 34% (95% CI 13-56%), P = 0.007. The hospital stay was shorter after vNOTES: 0.8 versus 1.3 days, mean difference À0.5 days, (95% CI À0.98 to À0.02), P = 0.004.Conclusions vNOTES is non-inferior to TLH for successfully performing hysterectomy without conversion. Compared with TLH, vNOTES may allow more women to be treated in a day-care setting.Keywords Core outcome set, day-care surgery, laparoscopic hysterectomy, randomised controlled trial, vNOTES.Tweetable abstract RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery.Please cite this paper as: Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol BWJ, Bosteels JJA. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG 2019;126:105-113.

Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy for uterus weighing ≥ 1kg

“…The vNOTES combined conventional vaginal surgery and single-port laparoscopy as emerging technique, several studies revealed that vNOTES hysterectomy for benign indications could be feasible and safe approach, and had advantages over traditional laparoscopic and vaginal hysterectomy, such as low complications, minimal post-surgical pain, fast recovery and short hospitalization [3,[11][12][13]. Currently, there was no publication about vNOTES hysterectomy in large uterus.…”

Impact of different intraoperative CO2 pressure levels (8 and 15 mmHg) during laparoscopic hysterectomy performed due to benign uterine pathologies on postoperative pain and arterial pCO2: a prospective randomised controlled clinical trial

“…Patients and the study nurses conducting postoperative assessments of all participants and data collection were blinded to treatment group allocation. No formal evaluation of the success of blinding was conducted, as no existing method for the assessment of blinding in clinical trials is regarded as standard …”

Authors’ reply re: Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a daycare procedure: a randomised controlled trial

“…We want to thank Dr Wright and colleagues for their interest in our HALON (hysterectomy by transabdominal laparoscopy or natural orifice transluminal endoscopic surgery) trial , …”

“…The HALON trial was the first published randomised controlled trial (RCT) comparing hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (vNOTES) with total laparoscopic hysterectomy (TLH) . This RCT demonstrated that vNOTES was not inferior to TLH to perform a hysterectomy for benign conditions.…”