Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

Not Applicable

• Conditions: Endometrium Cancer
• Interventions: Procedure: Traditional surgery type; Procedure: Robotic assisted laparoscopic surgery

• Registration Number: NCT01466777
• Lead Sponsor: Tampere University Hospital

Brief Summary

The aim of this study is to compare the robotic-assisted laparoscopic surgery to the traditional laparoscopic surgery in endometrial cancer patients.

The study is prospective and the patients are randomised into two groups of 50 patients each. Randomisation is done with Minim-programme and patients age and Body mass index are taken into account.

The primary endpoint is the operation time. The number of patients in this study is based on the non-inferiority design. Presumption is that the operation time in robotic-assisted laparoscopy will be 25% longer.

Secondary endpoints include:

1. bleeding

2. complications

3. conversions

4. number of pelvic lymph nodes

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-11-03
• Study First Posted: 2011-11-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-06
• Primary Completion: 2019-08
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Endometrial cancer operations, which means hysterectomy, bilateral salphingo-oophorectomy and pelvic lymphadenectomy
• Gr 1 and 2 differentiation type

Exclusion Criteria

• The operation cannot be made with an laparoscopy operation
• Age more than 85 years or young under 30 years patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditional laparoscopic surgery type	Traditional surgery type	-
Robotic assisted operation type	Robotic assisted laparoscopic surgery	-

Primary Outcome Measures

Name	Time	Method
the operation time	From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours

Secondary Outcome Measures

Name	Time	Method
pelvic lymph node volumes	Duration of hospital stay, an expected average of 5 weeks
bleeding	Duration of hospital stay, an expected average of 5 weeks
Number of participants with adverse events	Duration of hospital stay, an expected average of 5 weeks
Pain	Duration of hospital stay, an expected average of 5 weeks	visual analogue scale

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, P.O.Box 2000, Finland