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

doi:10.1111/1471-0528.16838

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 journal › Article › peer-review

25 Citations (Scopus)

5 Downloads (Pure)

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 language	English
Pages (from-to)	1782-1791
Number of pages	10
Journal	BJOG-An International Journal of Obstetrics and Gynaecology
Volume	128
Issue number	11
Early online date	27 Jul 2021
DOIs	https://doi.org/10.1111/1471-0528.16838
Publication status	Published - 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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Baekelandt, J. F., De Mulder, P. A., Le Roy, I., Mathieu, C., Laenen, A., Enzlin, P., Morlion, B., Weyers, S., Mol, B. W. J., & Bosteels, J. J. (2021). Adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery versus laparoscopy: results of a first randomised controlled trial (NOTABLE trial) . BJOG-An International Journal of Obstetrics and Gynaecology, 128(11), 1782-1791. https://doi.org/10.1111/1471-0528.16838

Adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery versus laparoscopy: results of a first randomised controlled trial (NOTABLE trial) . / Baekelandt, Jan Filip (Corresponding Author); De Mulder, Peter A.; Le Roy, Ilse et al.
In: BJOG-An International Journal of Obstetrics and Gynaecology, Vol. 128, No. 11, 21.09.2021, p. 1782-1791.

Research output: Contribution to journal › Article › peer-review

Baekelandt, JF, De Mulder, PA, Le Roy, I, Mathieu, C, Laenen, A, Enzlin, P, Morlion, B, Weyers, S, Mol, BWJ & Bosteels, JJ 2021, 'Adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery versus laparoscopy: results of a first randomised controlled trial (NOTABLE trial) ', BJOG-An International Journal of Obstetrics and Gynaecology, vol. 128, no. 11, pp. 1782-1791. https://doi.org/10.1111/1471-0528.16838

Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P et al. Adnexectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery versus laparoscopy: results of a first randomised controlled trial (NOTABLE trial) . BJOG-An International Journal of Obstetrics and Gynaecology. 2021 Sept 21;128(11):1782-1791. Epub 2021 Jul 27. doi: 10.1111/1471-0528.16838

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

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 hospitalPopulation: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.4The 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 anendobag.",

keywords = "Adnexectomy, salpingo-oophorectomy, vNOTES, laparoscopy, randomised controlled trial",

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

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AU - Baekelandt, Jan Filip

AU - De Mulder, Peter A.

AU - Le Roy, Ilse

AU - Mathieu, Chantal

AU - Laenen, Annouschka

AU - Enzlin, Paul

AU - Morlion, Bart

AU - Weyers, Steven

AU - Mol, Ben W. J.

AU - Bosteels, Jan Ja

PY - 2021/9/21

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N2 - 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 hospitalPopulation: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.4The 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 anendobag.

AB - 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 hospitalPopulation: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.4The 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 anendobag.

KW - Adnexectomy

KW - salpingo-oophorectomy

KW - vNOTES

KW - laparoscopy

KW - randomised controlled trial

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JF - BJOG-An International Journal of Obstetrics and Gynaecology

IS - 11

ER -

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

Abstract

Data Availability Statement

Keywords

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