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Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT01526655
Recruitment Status : Unknown
Verified February 2016 by Preben Kjolhede, University Hospital, Linkoeping.
Recruitment status was:  Recruiting
First Posted : February 6, 2012
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Preben Kjolhede, University Hospital, Linkoeping

January 28, 2012
February 6, 2012
February 23, 2016
January 2012
June 2016   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01526655 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Complications [ Time Frame: Six weeks ]
    Adverse events (AE) and serious adverse events (SAE) are registered systematically from start of anesthesia to six weeks postoperatively
  • Changes in biomarkers for tissue damage [ Time Frame: During six weeks ]
    The biomarkers (high sensitive -C reactive protein (hs-CRP), creatin kinas (CK), high-mobility group protein B1 (HMGB1) and aminoacids (glutamin, glutamat, citrullin, arginin, ornitin, aspartat and taurin))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 ]
    The proinflammatory cytokines (interleukine-1 (IL-1), interleukine-6 (IL-6), CXCL8, tumour necrosis factor-alpha (TNF-alpha)), the antiinflammatoric 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 ]
    Blodsamples are collected on three occasions: one week preoperatively, one and six weeks postoperatively.
  • 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.
  • Consumption of analgesic [ Time Frame: Six weeks ]
    Use of analgesics is registrered during hospital stay. After discharge the patient makes notes in a study specific diary of the daily consumption of analgesic untill the six weeks visit.
  • Health economics [ Time Frame: Six weeks ]
    Direct and indirect costs for hospital stay and recovery period untill six weeks postoperatively. Quality-adjusted life years (QALY) and cost-effectiveness are determined.
  • Complications [ Time Frame: Six weeks ]
    Adverse events (AE) and serious adverse events (SAE) are registered systematically from start of anesthesia to six weeks postoperatively
Not Provided
Not Provided
 
Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer
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.
If detailed description is requested, please contact sponsor.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Endometrial Cancer
  • Procedure: Abdominal total hysterectomy
    Abdominal total hysterectomy through a low transverse abdominal wall incision
  • 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
    Intervention: Procedure: Abdominal total hysterectomy
  • Active Comparator: Robot assisted laparoscopic hysterectomy
    Robot assisted laparoscopic total hysterectomy
    Intervention: Procedure: Robot assisted laparoscopic hysterectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
Same as current
August 2016
June 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01526655
ROBOTHYST
Yes
Not Provided
Not Provided
Preben Kjolhede, University Hospital, Linkoeping
University Hospital, Linkoeping
Not Provided
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
University Hospital, Linkoeping
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP