Procedural sedation for hysteroscopic myomectomy: costeffectiveness

Recruiting

Conditions: Hysteroscopy, myomas, fibroids, resection, procedural sedation, cost-effectiveness, propofol, hysteroscopische myoomresectie

Registration Number: NL-OMON28160

Lead Sponsor: Máxima Medisch Centrum Veldhoven

Brief Summary: The principal investigator will publish the results of the study in a peer reviewed medical journal as soon as appropriate.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 205

Inclusion Criteria

The following women will be included:
-A minimum age of 18 years
-A maximum of 3 symptomatic type 0 and type 1 submucosal fibroids
-A maximum diameter of 3.5 cm (as diagnosed by transvaginal ultrasonography)
-American Society of Anaesthiologists (ASA) class 1 or 2
-Sufficient knowledge of Dutch or English language to fully understand the study and complete the questionnaires

Exclusion Criteria

-Presence of clotting disorders
-Severe anemia (Hb under 5.0 mmol/l)
-ASA class 3 or 4

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome will be the percentage of complete resections, evaluated by transvaginal ultrasonography (TVU) (contrast sonography if TVU is inconclusive) 6 weeks postoperatively. TVU will be performed by an independent gynecologist or ultrasonographer blinded for the surgery outcome.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are cost effectiveness, pain, menstrual blood loss (PBAC score), quality of life as assessed by questionnaires: EuroQoL (EQ-5D-5L), Recovery Index (RI-10) and Uterine Fibroid Symptoms – Quality of Life questionnaire (UFS-QoL), return to daily activities/work, hospitalization, Medical Consumption Questionnaire (iMCQ): for cost effectiveness analysis, Productivity Cost Questionnaire (iPCQ) to assess productivity loss, (post)operative complications, re-interventions.