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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.
If detailed description is requested, please contact sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal total hysterectomy | Active Comparator | Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision |
|
| Robot assisted laparoscopic hysterectomy | Active Comparator | Robot assisted laparoscopic total hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal total hysterectomy | Procedure | Abdominal total hysterectomy through a low transverse abdominal wall incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life (HRQoL) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Preben Kjölhede, MD, PhD | Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden | Study Chair |
| Evelyn Lundin, MD | Department of Obstetrics and Gynecology, University Hospital, 58185 Linköping, Sweden | Study Director |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Ryhov Central Hospital | Jönköping | Jönköping County | 551 85 | Sweden | ||
One patient withdrew consent prior to surgery in the control group (abdominal hysterectomy) and received the standard treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Robotic Hysterectomy | Robot assisted laparoscopic total hysterectomy |
| FG001 | Abdominal Hysterectomy | Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
50 women with low-risk endometrial cancer scheduled for surgery between February 2012 and May 2016 were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic Hysterectomy | Robot assisted laparoscopic total hysterectomy Robot assisted laparoscopic hysterectomy: Robot assisted laparoscopic total hysterectomy |
| BG001 | Abdominal Hysterectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Health Related Quality of Life (HRQoL) | 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. | Women with low-risk early stage endometrial cancer scheduled for radical surgery at the University Hospital in Linköping between February 2012 and may 2016 were asked to participate int the study according to the inclusion and exclusion criteria. | Posted | Mean | Standard Deviation | scores on a scale | Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42 |
|
From the day of surgery until six weeks postoperatively.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robotic Hysterectomy | Robot assisted laparoscopic total hysterectomy | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Reoperation vaginal vault bleeding | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound complications | Infections and infestations | Systematic Assessment |
Nothing to declare.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Dr. Preben Kjölhede | Department of Obstetrics and Gynaecology, and Department of Clinical and Experimental Medicine, Linköpings universitet (LIU), Sweden | +4638231188 | preben.kjolhede@liu.se |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| Robot assisted laparoscopic hysterectomy | Procedure | Robot assisted laparoscopic total hysterectomy |
|
| Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | 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)) | 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)) | 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) | 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) | 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) | 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. |
| Department of Obstetrics and Gynecology, University Hospital |
| Linköping |
| Östergötland County |
| 58185 |
| Sweden |
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
Abdominal total hysterectomy: Abdominal total hysterectomy through a low transverse abdominal wall incision
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body mass index | Median | Full Range | kg/m^2 |
|
| Body mass index | Count of Participants | Participants |
|
| Parity | Median | Full Range | births |
|
| Smokers | Count of Participants | Participants |
|
| Previous laparotomy | Count of Participants | Participants |
|
| Comorbidity | Count of Participants | Participants |
|
| Current medication | Count of Participants | Participants |
|
| ASA classification (American Society of Anesthesiologists physical status classification system) | ASA Physical Status Classification (ASA I to VI) (ASA I: a normal healthy patient, ASA II: a patient with mild systemic disease, ASA III: a patient with severe systemic disease) | Count of Participants | Participants |
|
| EQ-5D health index preoperatively (EuroQol Group form five dimensions) | The EQ-5D is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 3-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Values are anchored at 1 (full health) and 0 (death) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. | Median | Full Range | score on a scale |
|
| HADS Anxiety (Hospital Anxiety and Depression Scale) | Count of Participants | Participants |
|
| HADS Depression (Hospital Anxiety and Depression Scale) | Count of Participants | Participants |
|
| PSQ score (Pain Sensitivity Questionnaire score) | The PSQ is composed of 17 items, describing a daily life situation, asking to rate pain on a scale from 0 (not painful) to 10 (worst pain). 3 of the 17 situations are not normally painful and not included in the PSQ-total score(=an average score;17-3=14 items/14). The PSQ-minor is calculated as the average of 7 items of mild pain intensity of 14 items. The PSQ-moderate score is the calculated average rating of 7 items of moderate pain intensity of 14 items. In all scores higher values represent a worse outcome. Range of all three scores min 0 to max 10. | Median | Full Range | score on a scale (0-10) |
|
| Abdominal Hysterectomy |
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision |
|
|
|
| Secondary | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | 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. | Women with low-risk early stage endometrial cancer scheduled for radical surgery at the University Hospital in Linköping between February 2012 and may 2016 were asked to participate int the study according to the inclusion and exclusion criteria. | Posted | Mean | Standard Deviation | mg/L | One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery. |
|
|
|
|
| Secondary | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | 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. | Women with low-risk early stage endometrial cancer scheduled for radical surgery at the University Hospital in Linköping between February 2012 and may 2016 were asked to participate int the study according to the inclusion and exclusion criteria. | Posted | Mean | Standard Deviation | x10^9 cells/L | One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery. |
|
|
|
|
| Secondary | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | 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. | Women with low-risk early stage endometrial cancer scheduled for radical surgery at the University Hospital in Linköping between February 2012 and may 2016 were asked to participate int the study according to the inclusion and exclusion criteria. | Posted | Mean | Standard Deviation | pg/ml | One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery. |
|
|
|
|
| Secondary | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | 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. | Women with low-risk early stage endometrial cancer scheduled for radical surgery at the University Hospital in Linköping between February 2012 and may 2016 were asked to participate int the study according to the inclusion and exclusion criteria. | Posted | Mean | Standard Deviation | µkat/L | One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery. |
|
|
|
|
| Secondary | Changes in Biomarkers for Tissue Damage (Cortisol) | 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. | Women with low-risk early stage endometrial cancer scheduled for radical surgery at the University Hospital in Linköping between February 2012 and may 2016 were asked to participate int the study according to the inclusion and exclusion criteria. | Posted | Mean | Standard Deviation | nmol/L | One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery. |
|
|
|
|
| Secondary | Health Economics (With 300 Robotic Procedures Annually) | Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively. | Posted | Number | Swedish crowns per procedure | From the day of surgery until six weeks after surgery. |
|
|
|
|
| Secondary | Health Economics (With 500 Robotic Procedures Annually) | Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively. | Posted | Number | Swedish crowns per procedure | From the day of surgery until six weeks after surgery. |
|
|
|
|
| 25 |
| 0 |
| 25 |
| 8 |
| 25 |
| EG001 | Abdominal Hysterectomy | Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision | 0 | 24 | 2 | 24 | 15 | 24 |
| Bladder injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Vaginal vault hematoma | Blood and lymphatic system disorders | Systematic Assessment |
|
| Red blood cell transfusion | Blood and lymphatic system disorders | Systematic Assessment |
|
| Spinal punction not possible | Surgical and medical procedures | Systematic Assessment |
|
| Intubation difficulties | Surgical and medical procedures | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| BMI 30-35 |
|
| BMI > 35 |
|
| Class III |
|
| Severe anxiety |
|
| hsCRP time 3 |
|
| hsCRP time 4 |
|
| hsCRP time 5 |
|
| hsCRP time 6 |
|
| hsCRP time 7 |
|
| WBC time 3 |
|
| WBC time 4 |
|
| WBC time 5 |
|
| WBC time 6 |
|
| WBC time 7 |
|
| IL-6 time 3 |
|
| IL-6 time 4 |
|
| IL-6 time 5 |
|
| IL-6 time 6 |
|
| IL-6 time 7 |
|
| CK time 3 |
|
| CK time 4 |
|
| CK time 5 |
|
| CK time 6 |
|
| CK time 7 |
|
| Cortisol time 3 |
|
| Cortisol time 4 |
|
| Cortisol time 5 |
|
| Cortisol time 6 |
|
| Cortisol time 7 |
|
| Total costs (direct + indirect) per procedure |
|
| Total costs (direct + indirect) per procedure |
|