Robotic Versus Abdominal Surgery for Endometrial Cancer

NCT01847703CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Karolinska Institutet

Enrollment

120

Start Date

2013-04-01

Completion Date

2016-07-01

Study Type

INTERVENTIONAL

Official Title

Randomized Trial Comparing Robotic and Abdominal Surgery for High Risk Endometrial Cancer

Interventions

Robotic surgeryAbdominal surgery

Conditions

Endometrial Neoplasms

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

Inclusion Criteria:

* 18-75 years of age
* High risk endometrial cancer

Exclusion Criteria:

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

Outcome Measures

Primary Outcomes

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

Time frame: 2 years

Secondary Outcomes

Recurrence of cancer

Cancer recurrences will be recorded up to 3 years after surgery and categorized according to anatomical site

Time frame: 3 years

Lymphatic side-effects

Lymphatic side-effects will be monitored by repeated computed tomography (CT) 3 months and 12 months after surgery. Enrolled women will be asked specific, validated questions at follow-up

Time frame: 2 years

Quality of life

All included participants will be asked to fill out a questionnaire (EORTC) to assess quality of life before and 1 year after surgery

Time frame: 2 years

Healthcare cost

All costs related to each procedure including complications, re-admissions, rehabilitation, medication, radiology will be compared after 1 year.

Time frame: 2 years

Locations

Karolinska University Hospital, Stockholm, Sweden

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.