A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program

University Hospital, Linkoeping2 sites in 1 country50 target enrollmentJanuary 25, 2012

ConditionsEndometrial Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Endometrial Cancer
Sponsor: University Hospital, Linkoeping
Enrollment: 50
Locations: 2
Primary Endpoint: Health Related Quality of Life (HRQoL)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the trial is to determine whether robot assisted laparoscopic hysterectomy compared with abdominal hysterectomy in a fast track program gives a faster recovery postoperatively, causes less tissue damage and less effects on the immunological system, and is health economically cost-effective.

Detailed Description

If detailed description is requested, please contact sponsor.

Registry

clinicaltrials.gov

Start Date

January 25, 2012

End Date

July 27, 2016

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University Hospital, Linkoeping

Responsible Party

Principal Investigator

Preben Kjolhede, MD, professor

Professor

University Hospital, Linkoeping

Eligibility Criteria

Inclusion Criteria

•Over 18 years of age.
•Scheduled to total hysterectomy + bilateral salpingooophorectomy (BSAE) and peritoneal lavage because of endometrial carcinoma, International federation of gynecology and obstetrics (FIGO) stage 1, grade 1 and 2, with diploid DNA profile (i.e. low risk profile).
•WHO (World Health Organisation) performance status ≤
•Proficiency in Swedish
•Accept to participate in the study and has signed written informed consent document.
•The operation should be considered possible to be perform laparoscopically and by laparotomy through a low transverse abdominal wall incision.

Exclusion Criteria

•The operation is anticipated to comprise more than the hysterectomy + BSAE.
•A midline incision is planned for the laparotomy.
•Contraindications towards spinal anesthesia with intrathecally applied morphine.
•Physically disabled women who cannot be expected to be mobilized in accordance to the fast track program in a way similar to what is expected from not-physically disabled women.
•Mentally disabled women who cannot fill in the questionnaires or understand the consequences of participating in a trial.
•Severe psychiatric disease or on medication for psychiatric disease so that the physician consider participation in the trial inappropriate.

Outcomes

Primary Outcomes

Health Related Quality of Life (HRQoL)

Time Frame: Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42

Quality of life measured by means of the EuroQol form (EQ-5D). The EQ-5D form was completed daily during the first eight days after surgery, then once weekly for additional six weeks. The health state index has a possible range from 0 to 1 with a higher score meaning a better quality of life.

Secondary Outcomes

Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))(One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.)
Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))(One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.)
Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))(One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.)
Health Economics (With 300 Robotic Procedures Annually)(From the day of surgery until six weeks after surgery.)
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))(One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.)
Changes in Biomarkers for Tissue Damage (Cortisol)(One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.)
Health Economics (With 500 Robotic Procedures Annually)(From the day of surgery until six weeks after surgery.)