Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

April 11, 2024 updated by: Preben Kjolhede, MD, professor, University Hospital, Linkoeping

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

If detailed description is requested, please contact sponsor.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Jönköpings Län
      • Jönköping, Jönköpings Län, Sweden, 551 85
        • Department of Obstetrics and Gynecology, Ryhov Central Hospital
    • Östergötland
      • Linköping, Östergötland, Sweden, 58185
        • Department of Obstetrics and Gynecology, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 ≤ 2.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Robot assisted laparoscopic hysterectomy
Robot assisted laparoscopic total hysterectomy
Procedure: Robot assisted laparoscopic hysterectomy
Robot assisted laparoscopic total hysterectomy
Active Comparator: Abdominal total hysterectomy
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
Procedure: Abdominal total hysterectomy
Abdominal total hysterectomy through a low transverse abdominal wall incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))
Time Frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
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))
Time Frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))
Time Frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
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))
Time Frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
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)
Time Frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
The biomarker was measured on seven occasions. Time 1: one week before surgery. Time 2: just before surgery. Time 3: two hours postoperatively. Time 4: 24 hours postoperatively. Time 5: 48 hours postoperatively. Time 6: one week after surgery. Time 7: six weeks after surgery.
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)
Time Frame: From the day of surgery until six weeks after surgery.
Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.
From the day of surgery until six weeks after surgery.
Health Economics (With 500 Robotic Procedures Annually)
Time Frame: From the day of surgery until six weeks after surgery.
Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.
From the day of surgery until six weeks after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Linkoeping

Investigators

  • Study Chair: Preben Kjölhede, MD, PhD, Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
  • Study Director: Evelyn Lundin, MD, Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
  • Study Chair: Ninnie Borendal Wodlin, MD, PhD, Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
  • Study Chair: Lena Nilsson, MD, PhD, Department of Anesthesiology, University Hospital, 58185 Linköping, Sweden
  • Study Chair: Jan Ernerudh, MD, PhD, Department of Clinical Immunology, University Hospital, 58185 Linköping, Sweden
  • Study Chair: Per Carlsson, PhD, Centre for Medical Technology Assessment, University Hospital, 58185 Linköping, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2012

Primary Completion (Actual)

July 27, 2016

Study Completion (Actual)

July 27, 2016

Study Registration Dates

First Submitted

January 28, 2012

First Submitted That Met QC Criteria

February 1, 2012

First Posted (Estimated)

February 6, 2012

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROBOTHYST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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