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Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

NCT01466777 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-06-06

No results posted yet for this study

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

Conditions

  • Endometrium Cancer

Interventions

PROCEDURE

Traditional surgery type

Traditional laparoscopic surgery for endometrial cancer

PROCEDURE

Robotic assisted laparoscopic surgery

Robotic assisted laparoscopic surgery for endometrial cancer

Sponsors & Collaborators

  • Tampere University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2019-08-31
Completion
2019-09-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01466777 on ClinicalTrials.gov