VAginal NOTES versus Laparoscopic hysterectomy in Uterine Endometrioid Cancer (VALUE-study): a multicentre randomized trial.

VAginal NOTES versus Laparoscopic hysterectomy in Uterine Endometrioid Cancer (VALUE-study): a multicentre randomized trial. - VALUE study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51251

Enrollment

147

Registered

2021-03-25

Start date

2022-05-20

Completion date

Unknown

Last updated

2025-12-15

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

Conditions

uterine cancer

Interventions

Patients are randomized between hysterectomy and bilateral salpingo-oophorectomy with vNOTES or conventional laparoscopy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: clinical stage 1 low- and intermediate risk endometrial cancer

Exclusion criteria

Exclusion criteria: non-endometrioid endometrial cancer, high stage disease

Design outcomes

Primary

Measure	Time frame
The primary outcome is percentage of women discharged on the of surgery (day 0). We calculated a sample size of 147 women assuming a 30% same day discharge difference with an alpha of 0.05 and a power of 90%. We plan to perform a follow up study of this trial to proof oncological safety of the procedure.	—

Secondary

Measure	Time frame
Secondary outcomes are removal of uterus via allocated technique, major complications, minor complications, operating time, conversion rate, blood loss, hospital stay, usage of analgesics, pain scores, costs and quality of life (QoL).	—

Countries

Netherlands

Contacts

Public ContactA.S. Tjalsma

Albert Schweitzer Ziekenhuis

a.s.tjalsma@asz.nl0786551923

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)