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

• Published in: BJOG : an international journal of obstetrics and gynaecology Vol. 126; no. 1; pp. 105 - 113
• Main Authors: Baekelandt, JF, De Mulder, PA, Le Roy, I, Mathieu, C, Laenen, A, Enzlin, P, Weyers, S, Mol, BWJ, Bosteels, JJA
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01-01-2019
• Subjects: Adult; Aged; Core outcome set; day‐care surgery; Endoscopy; Evidence-based medicine; Female; Humans; Hysterectomy; Hysterectomy - economics; Hysterectomy - methods; laparoscopic hysterectomy; Laparoscopy; Laparoscopy - economics; Laparoscopy - methods; Length of Stay; Middle Aged; Natural Orifice Endoscopic Surgery - economics; Natural Orifice Endoscopic Surgery - methods; Operative Time; Outcome Assessment, Health Care; Patient Reported Outcome Measures; randomised controlled trial; Sensitivity analysis; Single-Blind Method; Surgery; Uterus; vNOTES; randomised controlled trial; laparoscopic hysterectomy; Core outcome set; day-care surgery; vNOTES
• ISSN: 1470-0328; 1471-0528
• DOI: 10.1111/1471-0528.15504

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 one‐sided 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 −0.5 days, (95% CI −0.98 to −0.02), 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.
Tweetable
RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day‐care surgery.
Tweetable
RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day‐care surgery.
This paper includes Author Insights, a video available at https://vimeo.com/rcog/authorinsights15504.