Adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery versus laparoscopy: results of a first randomised controlled trial (NOTABLE trial)

Objective:
To compare adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) versus laparoscopy.
Design:
Parallel group, 1:1 single-centre single-blinded randomised trial, designed as a non-inferiority study with a margin of 15%.
Setting:
Belgian teaching hospital
Population:
Women regardless of age and parity scheduled to undergo an adnexectomy for an adnexal mass assessed to be benign on ultrasound by applying the IOTA criteria.
Methods:
Randomisation to laparoscopy (control group) or vNOTES (experimental group). Stratification according to adnexal size. Blinding of participants and outcome assessors by sham incisions.
Main Outcome Measures:
The primary outcome measure was adnexectomy by the allocated technique. Secondary outcomes included duration of surgery, pain scores and anlagesics used, and spilling in endobag.
Results:
We randomly assigned 67 participants (34 to the vNOTES group and 33 to the laparoscopy group). The primary endpoint was always reached in both groups: there were no conversions.
A sensitivity analysis for the primary outcome, assuming one conversion in the vNOTES group and no conversions in the laparoscopy group still demonstrated non-inferiority for vNOTES.
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The secondary outcomes demonstrated a shorter duration of surgery, lower pain scores, lower total dose of analgesics and a lower rate of spilling in the endobag for the vNOTES group.
Conclusions:
vNOTES is non-inferior to laparoscopy for a successful adnexectomy without conversion. vNOTES allowed shorter operating times, less postoperative pain and less spilling in an
endobag.