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

Abstract

BackgroundIn 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.MethodsThis 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.DiscussionThis 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 registrationDutch trial register, number NTR5357. Registered 11th of August 2015.Electronic supplementary materialThe online version of this article (10.1186/s12905-019-0742-1) contains supplementary material, which is available to authorized users.

Society of Family Planning clinical recommendations: Contraception and abortion care for persons who use substances

“…Most patients who use substances may safely obtain a surgical abortion in an outpatient setting [GRADE 2B]. Ample data supports use of ambulatory and outpatient surgical sites for surgical abortion with moderate or deep sedation [30][31][32] . Standard recommended protocols required for provision of routine moderate sedation (which vary by state and institution but generally include vital sign monitoring, readily available reversal agents, possibly capnography, and access to emergency care [33] ) are appropriate for patients who use substances [ 33 , 34 ].…”

Accuracy of Robot-Assisted Percutaneous Pedicle Screw Placement under Regional Anesthesia: A Retrospective Cohort Study

“…Robot-assisted pedicle screw placement is usually performed under general anesthesia to keep the body still and improve screw placement accuracy. However, general anesthesia may be associated with high percentages of perioperative complications and medical costs, especially for elderly patients [ 10 , 11 ]. In addition, some spine surgeons prefer patient feedback to reduce the possibility of nerve injury in some special surgeries, such as percutaneous endoscopic lumbar discectomy (PELD) and percutaneous kyphoplasty [ 12 , 13 ].…”

Accuracy of Robot-Assisted Percutaneous Pedicle Screw Placement Under Regional Anaesthesia: A Comparative Cohort Study

“…Robot-assisted pedicle screw placement is usually performed under general anaesthesia to keep the body still and improve screw placement accuracy. However, general anaesthesia may be associated with high percentages of perioperative complications and medical costs, especially for elderly patients [10,11]. In addition, some spine surgeons prefer patient feedback to reduce the possibility of nerve injury in some special surgeries, such as percutaneous endoscopic lumbar discectomy (PELD) and percutaneous kyphoplasty (PKP) [12,13].…”