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Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

Primary Purpose

Endometrium Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Traditional surgery type
Robotic assisted laparoscopic surgery
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrium Cancer focused on measuring Endometrium cancer, Robotic-assisted laparoscopy, Traditional laparoscopy, Laparoscopic surgery, Treatment, Operation time, Bleeding, Complications, Conversions, Pelvic lymph node

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

traditional laparoscopic surgery type

Robotic assisted operation type

Arm Description

Outcomes

Primary Outcome Measures

the operation time

Secondary Outcome Measures

bleeding
Number of participants with adverse events
Pain
visual analogue scale
pelvic lymph node volumes

Full Information

First Posted
August 18, 2011
Last Updated
June 5, 2019
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01466777
Brief Title
Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy
Official Title
Robotic-assisted vs. Traditional Laparoscopic Surgery in Treatment of Endometrial Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: bleeding complications conversions number of pelvic lymph nodes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrium Cancer
Keywords
Endometrium cancer, Robotic-assisted laparoscopy, Traditional laparoscopy, Laparoscopic surgery, Treatment, Operation time, Bleeding, Complications, Conversions, Pelvic lymph node

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
traditional laparoscopic surgery type
Arm Type
Active Comparator
Arm Title
Robotic assisted operation type
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Traditional surgery type
Intervention Description
Traditional laparoscopic surgery for endometrial cancer
Intervention Type
Procedure
Intervention Name(s)
Robotic assisted laparoscopic surgery
Intervention Description
Robotic assisted laparoscopic surgery for endometrial cancer
Primary Outcome Measure Information:
Title
the operation time
Time Frame
From the beginning of first wound incision to the closure of the wounds, an expected average of 3 hours
Secondary Outcome Measure Information:
Title
bleeding
Time Frame
Duration of hospital stay, an expected average of 5 weeks
Title
Number of participants with adverse events
Time Frame
Duration of hospital stay, an expected average of 5 weeks
Title
Pain
Description
visual analogue scale
Time Frame
Duration of hospital stay, an expected average of 5 weeks
Title
pelvic lymph node volumes
Time Frame
Duration of hospital stay, an expected average of 5 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
State/Province
P.O.Box 2000
ZIP/Postal Code
33521
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28937446
Citation
Vuorinen RK, Maenpaa MM, Nieminen K, Tomas EI, Luukkaala TH, Auvinen A, Maenpaa JU. Costs of Robotic-Assisted Versus Traditional Laparoscopy in Endometrial Cancer. Int J Gynecol Cancer. 2017 Oct;27(8):1788-1793. doi: 10.1097/IGC.0000000000001073.
Results Reference
derived

Learn more about this trial

Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

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