Urogynaecology

 > Prosecco
 EVA
 
 PEOPLE
 
 SAM
 
 MIRA
 PORTRET
 CUPIDO 1
 CUPIDO 2
 VUSIS-I
 VUSIS-II

 Avaulta
 CAMPUR
 CATH trial
 Compare
 Elevate Anterior
 Elevate Posterior
 Galapagoz
 HysNiche
 Kwaliteitsregistratie
 LigaSure
 MiniMo
 Misorest
 PARIS
 PERIGEE
 Pompoen
 SALTO
 Save U
 TOAST
 TRUDIL
 TVT-O vs TVT-S
 Vesselseal
 VROUW
 WoMan trial
 


PROSECCO



Procedural sedation for hysteroscopic myomectomy: cost effectiveness and patient preference.

Go to the Prosecco website.


Objective

Hysteroscopic myomectomies are performed in the majority of Dutch hospitals. The number of procedures for submucosal type 0 or I myomas between 1-3 cm performed in the operating room is estimated to be 3000 per year. Hysteroscopic myomectomy is currently performed in daycare under general anesthesia. A considerable cost reduction is expected when procedural sedation (PSA) is applied.
This study aims to demonstrate non-inferiority of complete hysteroscopic resection of submucous myomas under procedural sedation with propofol compared to hysteroscopic resection under general anesthesia.

Secondly, this study aims to compare the cost effectiveness, patient preference, pain, menstrual blood loss (PBAC score), quality of life, return to daily activities/work, hospitalization, (post)operative complications, re-interventions for hysteroscopic resection of submucous myomas under procedural sedation with propofol and for resection under general anesthesia.

Study design
Non-inferiority multi center randomised controlled trial 


Study population
Women with a maximum of 2 symptomatic type 0 or I submucous myomas with a maximum diameter of 3 cm. 

Inclusion criteria

  • - Minimum age: 18 years
  • - Symptomatic type 0 or I submucous myomas 
  • - Maximum number of myomas: 3
  • - Maximum diameter of submucous myomas: 3 cm
  • - American Society of Anesthesiologist class 1 or 2

Exclusion criteria

  • - Aged under 18 years
  • - Inability to understand Dutch 
  • - American Society of Anesthesiologist class 3 or 4
  • - Clotting disorders 
  • - Severe anemia (Hb under 5.0 mmol/l)


Intervention
Hysteroscopic resection of submucous myomas under procedural sedation with propofol, compared to general anesthesia


Outcome measures
Primary outcome

Primary outcome will be the percentage of complete resections, based on ultrasonography 6 weeks postoperatively by an independent gynaecologist or ultrasonographer blinded for the surgery outcome. This ultrasonography should be conducted in the follicular phase (first 14 days) of the menstrual cycle. A complete resection means that there are no signs of an intracavitary remaining of the myoma resected during hysteroscopic myomectomy on the transvaginal ultrasound.


Secondary outcomes

Secondary outcomes are cost effectiveness, patient preference, pain, menstrual blood loss (PBAC score), quality of life, return to daily activities/work, hospitalization, (post)operative complications, re-interventions. These secondary parameters will be assessed by several questionnaires.


Power/data analysis
The study is designed as a non-inferiority study, in which we want to investigate if hysteroscopic myomectomy under procedural sedation with propofol is non-inferior to the same surgical procedure under general anesthesia. With 205  women randomized we have 90% power to demonstrate non-inferiority, based on an estimated 2,5% incomplete resections in both groups, with an non-inferiority upper limit of 10% incomplete resections defined as non-inferior (i.e. a delta of 7.5%), an alpha of 0.025 and a drop-out rate of 10%.


Economic evaluation
Economic evaluation will be performed from a societal perspective. Both a cost-effectiveness and cost-utility analysis will be performed.

Time schedule
Total study time 48 months: preparation time 6 months, inclusion period 24 months, follow up 12 months, analysis 6 months


Projectleaders
Prof. Dr. M.Y. Bongers, gynaecologist, MMC, Veldhoven

Dr. H.S. Kok, gynaecologist, Alrijne Ziekenhuis, Leiden


Health Technology Assessment
Dr. J.E. Bosmans, assistant professor Health Technology Assessment, VUmc, Amsterdam


Methodology
Dr. K. Oude Rengerink, epidemiologist, AMC, Amsterdam

Drs. R.I. Tjon-Kon-Fat, methodologist, AMC, Amsterdam


Subsidy
ZonMW


Contact (researcher)

Julia van der Meulen

Arts-onderzoeker gynaecologie

MMC, Veldhoven

P: 06-45747985

E: julia.vander.meulen@mmc.nl