NCT01847703

Brief Summary

This study is intended to explore differences in oncologic and surgical safety between robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

3.3 years

First QC Date

May 2, 2013

Last Update Submit

March 5, 2018

Conditions

Endometrial Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Number of harvested lymph nodes

    Extracted lymphatic tissue from 3 stations (above inferior mesenteric artery, below inferior mesenteric artery, pelvic) is analysed by a pathologist and the number of nodes for each station recorded and compared between the two groups

    2 years

Secondary Outcomes (4)

  • Recurrence of cancer

    3 years

  • Lymphatic side-effects

    2 years

  • Quality of life

    2 years

  • Healthcare cost

    2 years

Study Arms (2)

Robotic surgery

EXPERIMENTAL

Experimental method, to be compared with standard care

Procedure: Robotic surgery

Abdominal surgery

ACTIVE COMPARATOR

Conventional open surgery (laparotomy)

Procedure: Abdominal surgery

Interventions

Robotic surgeryPROCEDURE

Minimal invasive surgery performed with daVinci robotic system

Robotic surgery
Abdominal surgeryPROCEDURE

Current gold standard

Abdominal surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • High risk endometrial cancer

You may not qualify if:

  • WHO performance\>1
  • Severe comorbidity, ASA\>3
  • Unable to understand information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (1)

  • Salehi S, Avall-Lundqvist E, Legerstam B, Carlson JW, Falconer H. Robot-assisted laparoscopy versus laparotomy for infrarenal paraaortic lymphadenectomy in women with high-risk endometrial cancer: A randomised controlled trial. Eur J Cancer. 2017 Jul;79:81-89. doi: 10.1016/j.ejca.2017.03.038. Epub 2017 Apr 29.

    PMID: 28463759DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Henrik Falconer, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 7, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2017

Last Updated

March 6, 2018

Record last verified: 2018-03

Locations

SE(1)