Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial

Julia F van der Meulen; Marlies Y Bongers; Lisa G van der Zee; Jaklien C Leemans; Ruben G Duijnhoven; Robert A de Leeuw; Lucilla E Overdijk; Celine M Radder; Lucet F van der Voet; Nicol A C Smeets; Huib A A M van Vliet; Wouter J K Hehenkamp; Arentje P Manger; Arianne C Lim; Louisette W Peters; Nicole Horree; Justine M Briët; Jan Willem van der Steeg; Sjors F P J Coppus; Helen S Kok

doi:https://doi.org/10.1371/journal.pmed.1004323

Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial

Julia F van der Meulen, Marlies Y Bongers, Lisa G van der Zee, Jaklien C Leemans, Ruben G Duijnhoven, Robert A de Leeuw, Lucilla E Overdijk, Celine M Radder, Lucet F van der Voet, Nicol A C Smeets, Huib A A M van Vliet, Wouter J K Hehenkamp, Arentje P Manger, Arianne C Lim, Louisette W Peters, Nicole Horree, Justine M Briët, Jan Willem van der Steeg, Sjors F P J Coppus, Helen S Kok

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

Abstract

Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia.

Original language	English
Article number	1004323
Pages (from-to)	e1004323
Journal	PLoS medicine
Volume	20
Issue number	12
DOIs	https://doi.org/10.1371/journal.pmed.1004323
Publication status	Published - 1 Dec 2023

Access to Document

https://doi.org/10.1371/journal.pmed.1004323

Cite this

van der Meulen, J. F., Bongers, M. Y., van der Zee, L. G., Leemans, J. C., Duijnhoven, R. G., de Leeuw, R. A., Overdijk, L. E., Radder, C. M., van der Voet, L. F., Smeets, N. A. C., van Vliet, H. A. A. M., Hehenkamp, W. J. K., Manger, A. P., Lim, A. C., Peters, L. W., Horree, N., Briët, J. M., van der Steeg, J. W., Coppus, S. F. P. J., & Kok, H. S. (2023). Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial. PLoS medicine, 20(12), e1004323. Article 1004323. https://doi.org/10.1371/journal.pmed.1004323

@article{4dca27041537490ca37ff6b3db167393,

title = "Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial",

abstract = "Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia.",

author = "{van der Meulen}, {Julia F} and Bongers, {Marlies Y} and {van der Zee}, {Lisa G} and Leemans, {Jaklien C} and Duijnhoven, {Ruben G} and {de Leeuw}, {Robert A} and Overdijk, {Lucilla E} and Radder, {Celine M} and {van der Voet}, {Lucet F} and Smeets, {Nicol A C} and {van Vliet}, {Huib A A M} and Hehenkamp, {Wouter J K} and Manger, {Arentje P} and Lim, {Arianne C} and Peters, {Louisette W} and Nicole Horree and Bri{\"e}t, {Justine M} and {van der Steeg}, {Jan Willem} and Coppus, {Sjors F P J} and Kok, {Helen S}",

note = "Funding Information: Funding: This study was funded by The Dutch organisation for Health Research and Development (ZonMW -https://www.zonmw.nl/nl/), which is a governmental funding organisation. Grant number 843002603. This grant was awarded to MB, SC, HK, JvdM, CR, LO. Before receiving the grant this study protocol was peer-reviewed by ZonMW. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: Copyright: {\textcopyright} 2023 van der Meulen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License,",

year = "2023",

month = dec,

day = "1",

doi = "https://doi.org/10.1371/journal.pmed.1004323",

language = "English",

volume = "20",

pages = "e1004323",

journal = "PLoS medicine",

issn = "1549-1277",

publisher = "Nature Publishing Group",

number = "12",

}

van der Meulen, JF, Bongers, MY, van der Zee, LG, Leemans, JC, Duijnhoven, RG , de Leeuw, RA, Overdijk, LE, Radder, CM, van der Voet, LF, Smeets, NAC, van Vliet, HAAM, Hehenkamp, WJK, Manger, AP, Lim, AC, Peters, LW, Horree, N, Briët, JM, van der Steeg, JW, Coppus, SFPJ & Kok, HS 2023, 'Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial', PLoS medicine, vol. 20, no. 12, 1004323, pp. e1004323. https://doi.org/10.1371/journal.pmed.1004323

Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial. / van der Meulen, Julia F; Bongers, Marlies Y; van der Zee, Lisa G et al.
In: PLoS medicine, Vol. 20, No. 12, 1004323, 01.12.2023, p. e1004323.

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

TY - JOUR

T1 - Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial)

T2 - A multicenter randomized controlled trial

AU - van der Meulen, Julia F

AU - Bongers, Marlies Y

AU - van der Zee, Lisa G

AU - Leemans, Jaklien C

AU - Duijnhoven, Ruben G

AU - de Leeuw, Robert A

AU - Overdijk, Lucilla E

AU - Radder, Celine M

AU - van der Voet, Lucet F

AU - Smeets, Nicol A C

AU - van Vliet, Huib A A M

AU - Hehenkamp, Wouter J K

AU - Manger, Arentje P

AU - Lim, Arianne C

AU - Peters, Louisette W

AU - Horree, Nicole

AU - Briët, Justine M

AU - van der Steeg, Jan Willem

AU - Coppus, Sjors F P J

AU - Kok, Helen S

N1 - Funding Information: Funding: This study was funded by The Dutch organisation for Health Research and Development (ZonMW -https://www.zonmw.nl/nl/), which is a governmental funding organisation. Grant number 843002603. This grant was awarded to MB, SC, HK, JvdM, CR, LO. Before receiving the grant this study protocol was peer-reviewed by ZonMW. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Publisher Copyright: Copyright: © 2023 van der Meulen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License,

PY - 2023/12/1

Y1 - 2023/12/1

N2 - Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia.

AB - Hysteroscopic resection is the first-choice treatment for symptomatic type 0 and 1 fibroids. Traditionally, this was performed under general anesthesia. Over the last decade, surgical procedures are increasingly being performed in an outpatient setting under procedural sedation and analgesia. However, studies evaluating safety and effectiveness of hysteroscopic myomectomy under procedural sedation are lacking. This study aims to investigate whether hysteroscopic myomectomy under procedural sedation and analgesia with propofol is noninferior to hysteroscopic myomectomy under general anesthesia.

UR - http://www.scopus.com/inward/record.url?scp=85181097852&partnerID=8YFLogxK

U2 - https://doi.org/10.1371/journal.pmed.1004323

DO - https://doi.org/10.1371/journal.pmed.1004323

M3 - Article

C2 - 38153958

SN - 1549-1277

VL - 20

SP - e1004323

JO - PLoS medicine

JF - PLoS medicine

IS - 12

M1 - 1004323

ER -

Procedural sedation and analgesia versus general anesthesia for hysteroscopic myomectomy (PROSECCO trial): A multicenter randomized controlled trial

Abstract

Access to Document

Other files and links

Cite this