Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

Tampere University Hospital

Status: Unknown

Conditions: Endometrium Cancer

Treatments: Procedure: Robotic assisted laparoscopic surgery; Procedure: Traditional surgery type

Study type: Interventional

Funder types: Other

Identifiers

NCT01466777

R10081

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

traditional laparoscopic surgery type

Active Comparator group

Treatment:

Procedure: Traditional surgery type

Robotic assisted operation type

Experimental group

Treatment:

Procedure: Robotic assisted laparoscopic surgery