Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer

Study Overview
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Brief Summary
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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
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If detailed description is requested, please contact sponsor.

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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Procedure: Abdominal total hysterectomy
* Procedure: Robot assisted laparoscopic hysterectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | 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. | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in biomarkers for tissue damage | 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. | During six weeks | 
| Changes in cytokines and chemokines | 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. | During six weeks | 
| Changes in amount and function of T, B and natural killer(NK) lymphocytes | Blood samples are collected on three occasions: one week preoperatively, one and six weeks postoperatively. | During six weeks | 
| Postoperative symptoms | 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. | Six weeks | 
| Consumption of analgesic | 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. | Six weeks | 
| Health economics | Direct and indirect costs for hospital stay and recovery period until six weeks postoperatively. Quality-adjusted life years (QALY) and cost-effectiveness are determined. | Six weeks | 
| Complications | Adverse events (AE) and serious adverse events (SAE) are registered systematically from start of anesthesia to six weeks postoperatively | Six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial cancer, Robot assisted laparoscopy, Abdominal hysterectomy, Fast track program