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

J. F. Baekelandt; P. A. De Mulder; I. Le Roy; C. Mathieu; A. Laenen; P. Enzlin; S. Weyers; Ben Willem J. Mol; J. J.A. Bosteels

doi:10.1111/1471-0528.15504

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

J. F. Baekelandt, P. A. De Mulder, I. Le Roy, C. Mathieu, A. Laenen, P. Enzlin, S. Weyers, Ben Willem J. Mol, J. J.A. Bosteels

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

106 Citations (Scopus)

Abstract

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 abstract: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery.

Original language	English
Pages (from-to)	105-113
Number of pages	9
Journal	BJOG: An International Journal of Obstetrics and Gynaecology
Volume	126
Issue number	1
Early online date	11 Dec 2018
DOIs	https://doi.org/10.1111/1471-0528.15504
Publication status	Published - Jan 2019

Bibliographical note

Acknowledgements
We thank all the women who consented to participate in the HALON trial as well as all nurses and residents in training: their enthusiasm and support as co‐researchers in this clinical project was indispensable. We are much indebted to Ms Inge Vervloet (IV), senior nurse at the day‐care unit for writing a standardised nursing protocol. We are very grateful to Ms Sofie and Christel De Wit, management secretaries of the Department of Obstetrics and Gynaecology for their logistical support and help with the randomisation. We acknowledge the efficient assistance by Mr Kris Engels and Mr Johan Peetermans (Actuarial and Budget Department) and Mr Mike Daubie (Research, Development and Quality Promotion Department) of the Belgian National Institute for Health and Disability Insurance for providing us the data of hysterectomies performed in 2016 in Belgium.

Keywords

Core outcome set
day-care surgery
laparoscopic hysterectomy
randomised controlled trial
vNOTES

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Cite this

Baekelandt, J. F., De Mulder, P. A., Le Roy, I., Mathieu, C., Laenen, A., Enzlin, P., Weyers, S., Mol, B. W. J., & Bosteels, J. J. A. (2019). Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. BJOG: An International Journal of Obstetrics and Gynaecology, 126(1), 105-113. https://doi.org/10.1111/1471-0528.15504

Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial. / Baekelandt, J. F.; De Mulder, P. A.; Le Roy, I. et al.
In: BJOG: An International Journal of Obstetrics and Gynaecology, Vol. 126, No. 1, 01.2019, p. 105-113.

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

Baekelandt, JF, De Mulder, PA, Le Roy, I, Mathieu, C, Laenen, A, Enzlin, P, Weyers, S, Mol, BWJ & Bosteels, JJA 2019, 'Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial', BJOG: An International Journal of Obstetrics and Gynaecology, vol. 126, no. 1, pp. 105-113. https://doi.org/10.1111/1471-0528.15504

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abstract = "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 abstract: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery.",

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AU - Le Roy, I.

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AU - Mol, Ben Willem J.

AU - Bosteels, J. J.A.

N1 - Acknowledgements We thank all the women who consented to participate in the HALON trial as well as all nurses and residents in training: their enthusiasm and support as co‐researchers in this clinical project was indispensable. We are much indebted to Ms Inge Vervloet (IV), senior nurse at the day‐care unit for writing a standardised nursing protocol. We are very grateful to Ms Sofie and Christel De Wit, management secretaries of the Department of Obstetrics and Gynaecology for their logistical support and help with the randomisation. We acknowledge the efficient assistance by Mr Kris Engels and Mr Johan Peetermans (Actuarial and Budget Department) and Mr Mike Daubie (Research, Development and Quality Promotion Department) of the Belgian National Institute for Health and Disability Insurance for providing us the data of hysterectomies performed in 2016 in Belgium.

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N2 - 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 abstract: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery.

AB - 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 abstract: RCT: vNOTES is just as good as laparoscopy for successful hysterectomy without conversion but allows more day-care surgery.

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