Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

Endometrium Cancer Clinical Trial

Official title:

Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01466777
• Other study ID #: R10081
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2010
• Est. completion date: September 2019

Study information

• Verified date: June 2019
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Endometrium Cancer

Intervention

Procedure:
• Traditional surgery type
Traditional laparoscopic surgery for endometrial cancer
• Robotic assisted laparoscopic surgery
Robotic assisted laparoscopic surgery for endometrial cancer

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere	P.O.Box 2000

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the operation time		From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours
Secondary	bleeding		Duration of hospital stay, an expected average of 5 weeks
Secondary	Number of participants with adverse events		Duration of hospital stay, an expected average of 5 weeks
Secondary	Pain	visual analogue scale	Duration of hospital stay, an expected average of 5 weeks
Secondary	pelvic lymph node volumes		Duration of hospital stay, an expected average of 5 weeks