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

Phase 4

Recruiting

• Conditions: uterine cancer; endometrioid adenocarcinoma of the endometrium; 10038594; 10046828; 10029903

• Registration Number: NL-OMON51251
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 147

Inclusion Criteria

clinical stage 1 endometrial cancer

Exclusion Criteria

non-endometrioid endometrial cancer, high stage disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is percentage of women discharged on the same day as the<br /><br>hysterectomy (day 0).<br /><br><br /><br>We calculated a sample size of 147 women assuming a 30% same day discharge<br /><br>difference with an alpha of 0.05 and a power of 90%. We plan to perform a<br /><br>follow up study of this trial to proof oncological safety of the procedure. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are removal of uterus via allocated technique, major<br /><br>complications, minor complications, operating time, conversion rate, blood<br /><br>loss, hospital stay, usage of analgesics, pain scores, costs and quality of<br /><br>life (QoL). </p><br>