Procedural sedation for hysteroscopic myomectomy: cost effectiveness

Procedural sedation for hysteroscopic myomectomy: cost effectiveness - Prosecco

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50378

Enrollment

205

Registered

2015-12-14

Start date

2016-02-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fibroids submucosal myomas

Interventions

hysteroscopic myomectomy under procedural sedation with propofol compared to hysteroscopic myomectomy under general anesthesia.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Women with a minimum age of 18 years - Symptomatic type 0 or I submucous myomas - Maximum number of submucous myomas: 3 - Maximum diameter of submucous myomas: 3,5 cm - American Society of Anesthesiologist class 1 or 2

Exclusion criteria

Exclusion criteria: - Women aged under 18 years - Inability to understand Dutch or English - American Society of Anesthesiologist class 3 or 4 - Clotting disorders - Severe anemia (Hb under 5.0 mmol/l) - > 3 submucous myomas - diameter of submucous myoma > 3,5 cm

Design outcomes

Secondary

Measure	Time frame
Costs, pain, menstrual blood loss (PBAC score), quality of life, return to daily activities/work, hospitalization, (post)operative complications, re-interventions.	—

Primary

Measure	Time frame
complete resection	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)