TY - JOUR
T1 - The (cost) effectiveness of procedural sedation and analgesia versus general anaesthesia for hysteroscopic myomectomy, a multicentre randomised controlled trial
T2 - PROSECCO trial, a study protocol
AU - van der Meulen, Julia F
AU - Bongers, Marlies Y
AU - Coppus, Sjors F P J
AU - Bosmans, Judith E
AU - Maessen, José M C
AU - Oude Rengerink, Katrien
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 - Spaans, Wilbert A
AU - Bakkum, Erica A
AU - Horrée, Nicole
AU - Briët, Justine M
AU - van der Steeg, Jan Willem
AU - Kok, Helen S
N1 - Publisher Copyright:
© 2019 The Author(s).
PY - 2019/3/22
Y1 - 2019/3/22
N2 - 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.
AB - 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.
KW - General anaesthesia
KW - Hysteroscopic myomectomy
KW - Procedural sedation and analgesia
KW - Submucosal fibroids
U2 - 10.1186/s12905-019-0742-1
DO - 10.1186/s12905-019-0742-1
M3 - Article
C2 - 30902087
SN - 1472-6874
VL - 19
SP - 46
JO - BMC Women's Health
JF - BMC Women's Health
IS - 1
M1 - 46
ER -