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Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT01526655
Recruitment Status : Recruiting
First Posted : February 6, 2012
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Endometrial Cancer Procedure: Abdominal total hysterectomy Procedure: Robot assisted laparoscopic hysterectomy

Detailed Description:
If detailed description is requested, please contact sponsor.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Quality of life [ Time Frame: Six weeks ]
    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 :
  1. Changes in biomarkers for tissue damage [ Time Frame: During six weeks ]
    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.

  2. Changes in cytokines and chemokines [ Time Frame: During six weeks ]
    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.

  3. Changes in amount and function of T, B and natural killer(NK) lymphocytes [ Time Frame: During six weeks ]
    Blood samples are collected on three occasions: one week preoperatively, one and six weeks postoperatively.

  4. Postoperative symptoms [ Time Frame: Six weeks ]
    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.

  5. Consumption of analgesic [ Time Frame: Six weeks ]
    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.

  6. Health economics [ Time Frame: Six weeks ]
    Direct and indirect costs for hospital stay and recovery period until six weeks postoperatively. Quality-adjusted life years (QALY) and cost-effectiveness are determined.

  7. Complications [ Time Frame: Six weeks ]
    Adverse events (AE) and serious adverse events (SAE) are registered systematically from start of anesthesia to six weeks postoperatively


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526655


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

Responsible Party: Preben Kjolhede, Professor, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01526655     History of Changes
Other Study ID Numbers: ROBOTHYST
First Posted: February 6, 2012    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Preben Kjolhede, 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