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

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

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

21 Citations (Scopus)
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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
Pages (from-to)1782-1791
Number of pages10
JournalBJOG-An International Journal of Obstetrics and Gynaecology
Volume128
Issue number11
Early online date27 Jul 2021
DOIs
Publication statusPublished - 21 Sept 2021

Data Availability Statement

The data that support the findings of this study are avail-able from the corresponding author upon reasonable request.

Additional supporting information may be found online in the Supporting Information section at the end of the article.

Appendix S1. NOTABLE STUDY: statistical analysis.
Appendix S2. Baseline characteristics of the intention-to-treat population.
Appendix S3. NOTES Adnexectomy for Benign pathol-ogy compared with laparoscopic excision.
Appendix S4. NOTABLE Trial.
Video S1. vNOTES adnexectomy

Keywords

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

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