Endometrial Cancer and Robotic-assisted Versus Traditional Laparoscopy

NCT ID: NCT01466777

Last Updated: 2019-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2019-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Endometrium Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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traditional laparoscopic surgery type

Group Type ACTIVE_COMPARATOR

Traditional surgery type

Intervention Type PROCEDURE

Traditional laparoscopic surgery for endometrial cancer

Robotic assisted operation type

Group Type EXPERIMENTAL

Robotic assisted laparoscopic surgery

Intervention Type PROCEDURE

Robotic assisted laparoscopic surgery for endometrial cancer

Interventions

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Traditional surgery type

Traditional laparoscopic surgery for endometrial cancer

Intervention Type PROCEDURE

Robotic assisted laparoscopic surgery

Robotic assisted laparoscopic surgery for endometrial cancer

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Minna Mäenpää

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tampere University Hospital

Tampere, P.O.Box 2000, Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 28937446 (View on PubMed)

Other Identifiers

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R10081

Identifier Type: -

Identifier Source: org_study_id

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