The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial: PROSECCO trial, a study protocol

BMC Women's Health

Lucilla E. Overdijk¹  Judith E. Bosmans²  Helen S. Kok³  Huib A. A. M. van Vliet⁴  Lucet F. van der Voet⁵  Arentje P. Manger⁶  Nicole Horrée⁷  Jan Willem van der Steeg⁸  Wilbert A. Spaans⁹  Marlies Y. Bongers^1,10  Julia F. van der Meulen^1,10  Sjors F. P. J. Coppus^1,10  Erica A. Bakkum^1,11  Celine M. Radder^1,12  Wouter J. K. Hehenkamp^1,13  Justine M. Briët^1,14  Nicol A. C. Smeets^1,15  José M. C. Maessen^1,16  Katrien Oude Rengerink^1,17 

[1] Department of Anaesthesiology, Academic Medical Centre;Department of Health Sciences, Section of Health Economics & Health Technology Assessment, VU Medical Centre;Department of Obstetrics & Gynaecology, Alrijne Ziekenhuis;Department of Obstetrics & Gynaecology, Catharina Ziekenhuis;Department of Obstetrics & Gynaecology, Deventer Ziekenhuis;Department of Obstetrics & Gynaecology, Diakonessenhuis;Department of Obstetrics & Gynaecology, Flevoziekenhuis;Department of Obstetrics & Gynaecology, Jeroen Bosch Ziekenhuis;Department of Obstetrics & Gynaecology, MUMC;Department of Obstetrics & Gynaecology, Máxima Medical Centre;Department of Obstetrics & Gynaecology, Onze Lieve Vrouwe Gasthuis Oost;Department of Obstetrics & Gynaecology, Onze Lieve Vrouwe Gasthuis West;Department of Obstetrics & Gynaecology, VU Medical Centre;Department of Obstetrics & Gynaecology, Ziekenhuisgroep Twente;Department of Obstetrics & Gynaecology, Zuyderland Medical Centre;Department of Quality and Safety, MUMC;Julius Center of Health Sciences and Primary Care, UMC Utrecht;

关键词: Submucosal fibroids;    Hysteroscopic myomectomy;    Procedural sedation and analgesia;    General anaesthesia;   

DOI  :  10.1186/s12905-019-0742-1

来源: DOAJ

【 摘 要 】

Abstract Background In women with abnormal uterine bleeding, fibroids are a frequent finding. In case of heavy menstrual bleeding and presence of submucosal type 0–1 fibroids, hysteroscopic resection is the treatment of first choice, as removal of these fibroids is highly effective. Hysteroscopic myomectomy is currently usually performed in the operating theatre. A considerable reduction in costs and a higher patient satisfaction are expected when procedural sedation and analgesia with propofol (PSA) in an outpatient setting is applied. However, both safety and effectiveness – including the necessity for re-intervention due to incomplete resection – have not yet been evaluated. Methods This study is a multicentre randomised controlled trial with a non-inferiority design and will be performed in the Netherlands. Women > 18 years with a maximum of 3 symptomatic type 0 or 1 submucosal fibroids with a maximum diameter of 3.5 cm are eligible to participate in the trial. After informed consent, 205 women will be randomised to either hysteroscopic myomectomy using procedural sedation and analgesia with propofol in an outpatient setting or hysteroscopic myomectomy using general anaesthesia in a clinical setting in the operating theatre. Primary outcome will be the percentage of complete resections, based on transvaginal ultrasonography 6 weeks postoperatively. Secondary outcomes are cost effectiveness, menstrual blood loss (Pictorial blood assessment chart), quality of life, pain, return to daily activities/work, hospitalization, (post) operative complications and re-interventions. Women will be followed up to one year after hysteroscopic myomectomy. Discussion This study may demonstrate comparable effectiveness of hysteroscopic myomectomy under procedural sedation and analgesia versus general anaesthesia in a safe and patient friendly environment, whilst achieving a significant cost reduction. Trial registration Dutch trial register, number NTR5357. Registered 11th of August 2015.

【 授权许可】

Unknown