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

Meulen, Julia F. van der; Bongers, Marlies Y.; Coppus, S.F.P.J.; Bosmans, Judith E.; Maessen, J.; Rengerink, Katrien Oude; Overdijk, Lucilla E.; Radder, Celine M.; Voet, Lucet F. van der; Smeets, Nicol A.C.; Vliet, Huib A.A.M. van; Hehenkamp, Wouter J.K.; Manger, A Petra; Spaans, Wilbert; Bakkum, Erica A.; Horrée, Nicole; Briët, Justine M.; Steeg, Jan Willem van der; Kok, Helen S.

doi:10.1186/s12905-019-0742-1

Cited by 8 publications

(5 citation statements)

References 22 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The study was registered prospectively in the Dutch Trial Register (NTR 5357; registration date: 11 August 2015). The full study protocol was published in 2019 [ 32 ]. During the course of the study, no major changes to the study protocol were made.…”

Section: Methodsmentioning

confidence: 99%

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

van der Meulen,

Bongers,

van der Zee

et al. 2023

PLoS Med

Self Cite

View full text Add to dashboard Cite

Background 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. Methods and findings This was a multicenter, randomized controlled noninferiority trial conducted in 14 university and teaching hospitals in the Netherlands between 2016 and 2021. Inclusion criteria were age ≥18 years, maximum number of 3 type 0 or 1 fibroids, maximum fibroid diameter 3.5 cm, American Society of Anesthesiologists class 1 or 2, and having sufficient knowledge of the Dutch or English language. Women with clotting disorders or with severe anemia (Hb < 5.0 mmol/L) were excluded. Women were randomized using block randomization with variable block sizes of 2, 4, and 6, between hysteroscopic myomectomy under procedural sedation and analgesia (PSA) with propofol or under general anesthesia (GA). Primary outcome was the percentage of complete resections, assessed on transvaginal ultrasonography 6 weeks postoperatively by a sonographer blinded for the treatment arm and surgical outcome. Secondary outcomes were the surgeon’s judgment of completeness of procedure, menstrual blood loss, uterine fibroid related and general quality of life, pain, recovery, hospitalization, complications, and surgical reinterventions. Follow-up period was 1 year. The risk difference between both treatment arms was estimated, and a Farrington–Manning test was used to determine the p-value for noninferiority (noninferiority margin 7.5% of incomplete resections). Data were analyzed according to the intention-to-treat principle, including a per-protocol analysis for the primary outcome. A total of 209 women participated in the study and underwent hysteroscopic myomectomy with PSA (n = 106) or GA (n = 103). Mean age was 45.1 [SD 6.4] years in the PSA group versus 45.0 [7.7] years in the GA group. For 98/106 women in the PSA group and 89/103 women in the GA group, data were available for analysis of the primary outcome. Hysteroscopic resection was complete in 86/98 women (87.8%) in the PSA group and 79/89 women (88.8%) in the GA group (risk difference −1.01%; 95% confidence interval (CI) −10.36 to 8.34; noninferiority, P = 0.09). No serious anesthesiologic complications occurred, and conversion from PSA to GA was not required. During the follow-up period, 15 serious adverse events occurred (overnight admissions). All were unrelated to the intervention studied. Main limitations were the choice of primary outcome and the fact that our study proved to be underpowered. Conclusions Noninferiority of PSA for completeness of resection was not shown, though there were no significant differences in clinical outcomes and quality of life. In this study, hysteroscopic myomectomy for type 0 and 1 fibroids with PSA compared to GA was safe and led to shorter hospitalization. These results can be used for counseling patients by gynecologists and anesthesiologists. Based on these findings, we suggest that hysteroscopic myomectomies can be performed under PSA in an outpatient setting. Trial registration The study was registered prospectively in the Dutch Trial Register (NTR 5357; registration date: 11 August 2015; Date of initial participant enrollment: 18 February 2016).

show abstract

Section: Methodsmentioning

confidence: 99%

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

van der Meulen,

Bongers,

van der Zee

et al. 2023

PLoS Med

Self Cite

View full text Add to dashboard Cite

show abstract

“…Once we know the answers to these questions then trials can compare the relative merits of outpatient versus operating room setting. It is important that such trials (van der Meulen et al, 2019) clearly define the treatment setting including level of pain control according to the standardised nomenclature produced on behalf of the European Society of Gynaecological Endoscopy (ESGE), Global Congress of Hysteroscopy (GCH) and American Association of Gynecological Laparoscopy (AAGL, 2020;Carugno et al, 2021;Carugno et al,2022).…”

Section: Future Researchmentioning

confidence: 99%

Hysteroscopic removal of polyps and fibroids in the outpatient setting

Antoun,

Clark,

Clark

2023

Facts Views Vis ObGyn

View full text Add to dashboard Cite

Technological advances have facilitated the removal of endometrial polyps and submucous fibroids in an outpatient setting. This narrative review summarises the role, technologies and techniques, feasibility and effectiveness relating to outpatient hysteroscopic removal of uterine polyps and fibroids. A systematic electronic literature search of PubMed, Europe PMC, and Google Scholar in July 2023 was performed. The main outcome measures described were indications, patient selection and counselling, control of pain, modern definitions of treatment setting, available technologies, appropriate techniques and the evidence-base and future research directions. The results show that attention to patient counselling and the use of miniature instruments allowing vaginoscopy, and the judicious use of local anaesthesia with good technique are associated with improved patient experience and complete excision of uterine polyps and fibroids. Outpatient polypectomy is safe, feasible, acceptable, effective and cost-effective. Mechanical hysteroscopic tissue removal systems (mHTR) should be preferred to conventional mechanical instruments and electrosurgery because they are quicker, less painful, more acceptable and more successful. Outpatient hysteroscopic myomectomy is feasible using electrosurgery and mHTRs but appears more successful with smaller, more accessible fibroids. More research is needed surrounding case selection, identification of the best technologies and techniques and clinical effectiveness for hysteroscopic myomectomy in the outpatient setting.

show abstract

“…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 ].…”

Section: Can Patients Who Use Substances Be Cared For In the Outpatie...mentioning

confidence: 99%

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

et al. 2022

View full text Add to dashboard Cite

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

Cited by 8 publications

References 22 publications

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

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

Hysteroscopic removal of polyps and fibroids in the outpatient setting

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

Contact Info

Product

Resources

About