Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University Hospital, Linkoeping
Sponsor:
Information provided by (Responsible Party):
Preben Kjolhede, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01526655
First received: January 28, 2012
Last updated: May 27, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Endometrial Cancer
Procedure: Abdominal total hysterectomy
Procedure: Robot assisted laparoscopic hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Open Controlled Trial Comparing Robot Assisted Laparoscopic Hysterectomy and Abdominal Hysterectomy for Endometrial Cancer in a Fast Track Program

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Quality of life [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Quality of life measured by means of the Euroqol form (EQ-5D) and the Short form 36 (SF-36). The EQ-5D form is filled in on one occasion one week preoperatively, then daily in a week from the evening after surgery, then once weekly for additional five weeks. The SF-36 is filled in one week preoperatively and six weeks postoperatively.


Secondary Outcome Measures:
  • Changes in biomarkers for tissue damage [ Time Frame: During six weeks ] [ Designated as safety issue: No ]
    The biomarkers (high sensitive -C reactive protein (hs-CRP), creatin kinase (CK), high-mobility group protein B1 (HMGB1) and aminoacids (glutamin, glutamate, citruline, arginine, ornithine, aspartate and taurine))are measured preoperatively, 2, 24 and 48 hours after surgery, and 1 and 6 weeks postoperatively.

  • Changes in cytokines and chemokines [ Time Frame: During six weeks ] [ Designated as safety issue: No ]
    The proinflammatory cytokines (interleukine-1 (IL-1), interleukine-6 (IL-6), interleukine 8 (CXCL8), tumour necrosis factor-alpha (TNF-alpha)), the antiinflammatory cytokine (interleukine-10 (IL-10)) and the Th-1 mediated inflammatory chemokine (CXCL10) are measured preoperatively, 2, 24 and 48 hours after surgery, and 1 and 6 weeks postoperatively.

  • Changes in amount and function of T, B and natural killer(NK) lymphocytes [ Time Frame: During six weeks ] [ Designated as safety issue: No ]
    Blood samples are collected on three occasions: one week preoperatively, one and six weeks postoperatively.

  • Postoperative symptoms [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Symptoms are self-reported in the Swedish Postoperative Symptom Questionnaire. The questionnaire are filled in on one occasion one week preoperatively, then once daily for a week from day of surgery; thereafter once weekly for additional five weeks.

  • Consumption of analgesic [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Use of analgesics is registered during hospital stay. After discharge the patient makes notes in a study specific diary of the daily consumption of analgesic until the six weeks visit.

  • Health economics [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Direct and indirect costs for hospital stay and recovery period until six weeks postoperatively. Quality-adjusted life years (QALY) and cost-effectiveness are determined.

  • Complications [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Adverse events (AE) and serious adverse events (SAE) are registered systematically from start of anesthesia to six weeks postoperatively


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Robot assisted laparoscopic hysterectomy
Robot assisted laparoscopic total hysterectomy
Procedure: Robot assisted laparoscopic hysterectomy
Robot assisted laparoscopic total hysterectomy

Detailed Description:

If detailed description is requested, please contact sponsor.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526655

Contacts
Contact: Preben Kjölhede, MD, PhD +46101030000 ext 3187 Preben.Kjolhede@lio.se
Contact: Evelyn Lundin, MD +46101030000 Evelyn.Lundin@lio.se

Locations
Sweden
Department of Obstetrics and Gynecology, Ryhov Central Hospital Not yet recruiting
Jönköping, Jönköpings län, Sweden, 551 85
Contact: Laila Falknäs, MD    +4636321000    Laila.Falknas@lj.se   
Contact: Johan Skoglund, MD    +4636321000    Johan.Skoglund@lj.se   
Principal Investigator: Laila Falknäs, MD         
Sub-Investigator: Johan Skoglund, MD         
Department of Obstetrics and Gynecology, University Hospital Recruiting
Linköping, Östergötland, Sweden, 58185
Contact: Preben Kjölhede, MD, PhD    +46101030000 ext 3187    Preben.Kjolhede@lio.se   
Contact: Evelyn Lundin, MD    +46101030000    Evelyn.Lundin@lio.se   
Principal Investigator: Preben Kjölhede, MD, PhD         
Sub-Investigator: Evelyn Lundin, MD         
Sub-Investigator: Shefqet Halili, MD         
Sub-Investigator: Peter Lukas, MD         
Sub-Investigator: Gulnara Kassymova, MD         
Sub-Investigator: Ninnie Borendal Wodlin, MD, PhD         
Sponsors and Collaborators
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 Chair: Göran Berg, MD, PhD Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
Study Director: Måns Muhrbeck, MD Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden
  More Information

No publications provided

Responsible Party: Preben Kjolhede, Professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01526655     History of Changes
Other Study ID Numbers: ROBOTHYST
Study First Received: January 28, 2012
Last Updated: May 27, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
Endometrial cancer
Robot assisted laparoscopy
Abdominal hysterectomy
Fast track program

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 19, 2014