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

Jan Filip Baekelandt, Peter A. De Mulder, Ilse Le Roy, Chantal Mathieu, Annouschka Laenen, Paul Enzlin, Bart Morlion, Steven Weyers, Ben W. J. Mol, Jan Ja Bosteels

Research output: Contribution to journalArticlepeer-review

Abstract

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.
4
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.
Original languageEnglish
JournalBJOG-An International Journal of Obstetrics and Gynaecology
Publication statusAccepted/In press - 11 May 2021

Keywords

  • Adnexectomy
  • salpingo-oophorectomy
  • vNOTES
  • laparoscopy
  • randomised controlled trial

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