Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01466777

Enrollment

100

Registered

2011-11-08

Start date

2010-11-30

Completion date

2019-09-30

Last updated

2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrium Cancer

Keywords

Endometrium cancer, Robotic-assisted laparoscopy, Traditional laparoscopy, Laparoscopic surgery, Treatment, Operation time, Bleeding, Complications, Conversions, Pelvic lymph node

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

Interventions

PROCEDURETraditional surgery type

Traditional laparoscopic surgery for endometrial cancer

PROCEDURERobotic assisted laparoscopic surgery

Robotic assisted laparoscopic surgery for endometrial cancer

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 85 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
pelvic lymph node volumes	Duration of hospital stay, an expected average of 5 weeks	—

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026