Endometrial Cancer
Conditions
Keywords
Endometrial cancer, Robot assisted laparoscopy, Abdominal hysterectomy, Fast track program
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.
Detailed description
If detailed description is requested, please contact sponsor.
Interventions
PROCEDUREAbdominal total hysterectomy
Abdominal total hysterectomy through a low transverse abdominal wall incision
Robot assisted laparoscopic total hysterectomy
Sponsors
University Hospital, Linkoeping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 (World Health Organisation) 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life (HRQoL) | Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery. | 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. |
| Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery. | 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. |
| Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery. | 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. |
| Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery. | 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. |
| Health Economics (With 300 Robotic Procedures Annually) | From the day of surgery until six weeks after surgery. | Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively. |
| Health Economics (With 500 Robotic Procedures Annually) | From the day of surgery until six weeks after surgery. | Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively. |
| Changes in Biomarkers for Tissue Damage (Cortisol) | One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery. | 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. |
Countries
Sweden
Participant flow
Pre-assignment details
One patient withdrew consent prior to surgery in the control group (abdominal hysterectomy) and received the standard treatment.
Participants by arm
| Arm | Count |
|---|---|
| Robotic Hysterectomy Robot assisted laparoscopic total hysterectomy
Robot assisted laparoscopic hysterectomy: Robot assisted laparoscopic total hysterectomy | 25 |
| Abdominal Hysterectomy 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 | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Abdominal Hysterectomy | Total | Robotic Hysterectomy |
|---|---|---|---|
| Age, Continuous | 67 years | 67 years | 68 years |
| ASA classification (American Society of Anesthesiologists physical status classification system) Class I | 11 Participants | 20 Participants | 9 Participants |
| ASA classification (American Society of Anesthesiologists physical status classification system) Class II | 13 Participants | 28 Participants | 15 Participants |
| ASA classification (American Society of Anesthesiologists physical status classification system) Class III | 1 Participants | 2 Participants | 1 Participants |
| Body mass index BMI <25 | 8 Participants | 15 Participants | 7 Participants |
| Body mass index BMI 25-29.9 | 10 Participants | 18 Participants | 8 Participants |
| Body mass index BMI 30-35 | 5 Participants | 11 Participants | 6 Participants |
| Body mass index BMI > 35 | 2 Participants | 6 Participants | 4 Participants |
| Body mass index | 28.0 kg/m^2 | 28.1 kg/m^2 | 28.2 kg/m^2 |
| Comorbidity Cardiovascular disease | 11 Participants | 21 Participants | 10 Participants |
| Comorbidity Diabetes mellitus | 4 Participants | 4 Participants | 0 Participants |
| Comorbidity Previous breast cancer | 3 Participants | 6 Participants | 3 Participants |
| Comorbidity Pulmonary disease | 3 Participants | 6 Participants | 3 Participants |
| Current medication Analgesics | 2 Participants | 7 Participants | 5 Participants |
| Current medication Antidepressant/sedative | 3 Participants | 5 Participants | 2 Participants |
| EQ-5D health index preoperatively (EuroQol Group form five dimensions) | 0.82 score on a scale | 0.81 score on a scale | 0.81 score on a scale |
| HADS Anxiety (Hospital Anxiety and Depression Scale) Mild-moderate anxiety | 6 Participants | 15 Participants | 9 Participants |
| HADS Anxiety (Hospital Anxiety and Depression Scale) No anxiety | 15 Participants | 28 Participants | 13 Participants |
| HADS Anxiety (Hospital Anxiety and Depression Scale) Severe anxiety | 4 Participants | 7 Participants | 3 Participants |
| HADS Depression (Hospital Anxiety and Depression Scale) Mild-moderate depression | 4 Participants | 8 Participants | 4 Participants |
| HADS Depression (Hospital Anxiety and Depression Scale) No depression | 21 Participants | 42 Participants | 21 Participants |
| Parity | 2 births | 2 births | 2 births |
| Previous laparotomy | 8 Participants | 21 Participants | 13 Participants |
| PSQ score (Pain Sensitivity Questionnaire score) PSQ minor score (range 0-10) | 2.3 score on a scale (0-10) | 2.3 score on a scale (0-10) | 2.1 score on a scale (0-10) |
| PSQ score (Pain Sensitivity Questionnaire score) PSQ moderate score(range 0-10) | 4.4 score on a scale (0-10) | 4.4 score on a scale (0-10) | 4.4 score on a scale (0-10) |
| PSQ score (Pain Sensitivity Questionnaire score) PSQ total score (range 0-10) | 3.3 score on a scale (0-10) | 3.1 score on a scale (0-10) | 2.9 score on a scale (0-10) |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Sweden | 25 Participants | 50 Participants | 25 Participants |
| Sex/Gender, Customized Female | 25 Participants | 50 Participants | 25 Participants |
| Smokers | 0 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 24 |
| other Total, other adverse events | 8 / 25 | 15 / 24 |
| serious Total, serious adverse events | 0 / 25 | 2 / 24 |
Outcome results
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.
Time frame: Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 2 | 0.74 scores on a scale | Standard Deviation 0.19 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 7 | 0.83 scores on a scale | Standard Deviation 0.22 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 4 | 0.77 scores on a scale | Standard Deviation 0.19 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 14 | 0.88 scores on a scale | Standard Deviation 0.11 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 1 | 0.66 scores on a scale | Standard Deviation 0.24 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 21 | 0.91 scores on a scale | Standard Deviation 0.12 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 5 | 0.83 scores on a scale | Standard Deviation 0.18 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 28 | 0.92 scores on a scale | Standard Deviation 0.1 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 3 | 0.73 scores on a scale | Standard Deviation 0.19 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 35 | 0.93 scores on a scale | Standard Deviation 0.12 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 6 | 0.84 scores on a scale | Standard Deviation 0.17 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 42 | 0.95 scores on a scale | Standard Deviation 0.09 |
| Robotic Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 0 | 0.34 scores on a scale | Standard Deviation 0.4 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 42 | 0.86 scores on a scale | Standard Deviation 0.22 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 0 | 0.30 scores on a scale | Standard Deviation 0.53 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 1 | 0.48 scores on a scale | Standard Deviation 0.4 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 2 | 0.56 scores on a scale | Standard Deviation 0.31 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 3 | 0.59 scores on a scale | Standard Deviation 0.28 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 4 | 0.63 scores on a scale | Standard Deviation 0.3 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 5 | 0.64 scores on a scale | Standard Deviation 0.31 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 6 | 0.67 scores on a scale | Standard Deviation 0.25 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 7 | 0.66 scores on a scale | Standard Deviation 0.29 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 14 | 0.73 scores on a scale | Standard Deviation 0.22 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 21 | 0.71 scores on a scale | Standard Deviation 0.31 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 28 | 0.76 scores on a scale | Standard Deviation 0.29 |
| Abdominal Hysterectomy | Health Related Quality of Life (HRQoL) | EQ-5D Day 35 | 0.82 scores on a scale | Standard Deviation 0.26 |
p-value: 0.011ANOVA
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.
Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 2 | 489.0 nmol/L | Standard Deviation 137 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 4 | 392.0 nmol/L | Standard Deviation 201 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 5 | 358.1 nmol/L | Standard Deviation 128 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 1 | 273.4 nmol/L | Standard Deviation 75 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 6 | 309.1 nmol/L | Standard Deviation 98 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 7 | 307.0 nmol/L | Standard Deviation 129 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 3 | 301.0 nmol/L | Standard Deviation 267 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 7 | 331.1 nmol/L | Standard Deviation 125.4 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 6 | 331.0 nmol/L | Standard Deviation 76 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 1 | 266.0 nmol/L | Standard Deviation 123.2 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 2 | 510.1 nmol/L | Standard Deviation 131.2 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 3 | 533.2 nmol/L | Standard Deviation 249 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 5 | 379.0 nmol/L | Standard Deviation 125.4 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Cortisol) | Cortisol time 4 | 383.0 nmol/L | Standard Deviation 178.1 |
p-value: 0.06ANOVA
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.
Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 5 | 46.3 mg/L | Standard Deviation 49.8 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 4 | 29.0 mg/L | Standard Deviation 29.4 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 2 | 2.7 mg/L | Standard Deviation 2.6 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 6 | 10.5 mg/L | Standard Deviation 8.6 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 1 | 2.5 mg/L | Standard Deviation 2.1 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 7 | 2.9 mg/L | Standard Deviation 2.6 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 3 | 2.3 mg/L | Standard Deviation 2.3 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 7 | 1.9 mg/L | Standard Deviation 1.5 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 1 | 6.0 mg/L | Standard Deviation 17 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 2 | 4.7 mg/L | Standard Deviation 11.4 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 3 | 3.5 mg/L | Standard Deviation 6.7 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 5 | 75.4 mg/L | Standard Deviation 43.7 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 6 | 9.3 mg/L | Standard Deviation 8.6 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP)) | hsCRP time 4 | 52.3 mg/L | Standard Deviation 27 |
p-value: 0.03ANOVA
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.
Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 2 | 1.9 µkat/L | Standard Deviation 1.1 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 5 | 3.0 µkat/L | Standard Deviation 2.4 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 3 | 1.5 µkat/L | Standard Deviation 0.9 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 6 | 1.0 µkat/L | Standard Deviation 0.6 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 1 | 1.8 µkat/L | Standard Deviation 1.1 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 7 | 1.6 µkat/L | Standard Deviation 1.1 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 4 | 3.3 µkat/L | Standard Deviation 2.5 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 7 | 1.3 µkat/L | Standard Deviation 0.8 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 2 | 1.6 µkat/L | Standard Deviation 1 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 3 | 2.5 µkat/L | Standard Deviation 1 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 4 | 6.2 µkat/L | Standard Deviation 4.9 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 5 | 4.5 µkat/L | Standard Deviation 2.1 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 6 | 0.9 µkat/L | Standard Deviation 0.6 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK)) | CK time 1 | 1.6 µkat/L | Standard Deviation 1.1 |
p-value: 0.03ANOVA
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.
Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 2 | 15.7 pg/ml | Standard Deviation 29 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 4 | 28.0 pg/ml | Standard Deviation 31 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 1 | 15.0 pg/ml | Standard Deviation 29.8 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 5 | 15.3 pg/ml | Standard Deviation 21.8 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 3 | 21.0 pg/ml | Standard Deviation 28.7 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 7 | 13.1 pg/ml | Standard Deviation 25.7 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 6 | 18.4 pg/ml | Standard Deviation 31.2 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 7 | 12.2 pg/ml | Standard Deviation 28.8 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 6 | 10.0 pg/ml | Standard Deviation 12.1 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 1 | 10.9 pg/ml | Standard Deviation 19 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 2 | 9.6 pg/ml | Standard Deviation 13.8 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 3 | 47.6 pg/ml | Standard Deviation 24.5 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 4 | 37.9 pg/ml | Standard Deviation 19 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6)) | IL-6 time 5 | 17.3 pg/ml | Standard Deviation 9.4 |
p-value: 0.03ANOVA
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.
Time frame: One week and just before surgery. Two, 24 and 48 hours postoperatively. One and six weeks after surgery.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 2 | 6.2 x10^9 cells/L | Standard Deviation 1.7 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 4 | 9.4 x10^9 cells/L | Standard Deviation 3.3 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 6 | 7.2 x10^9 cells/L | Standard Deviation 2 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 5 | 7.2 x10^9 cells/L | Standard Deviation 2.3 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 3 | 6.8 x10^9 cells/L | Standard Deviation 3 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 7 | 6.5 x10^9 cells/L | Standard Deviation 1.5 |
| Robotic Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 1 | 6.7 x10^9 cells/L | Standard Deviation 1.7 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 7 | 6.8 x10^9 cells/L | Standard Deviation 1.6 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 1 | 7.7 x10^9 cells/L | Standard Deviation 2.1 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 6 | 7.6 x10^9 cells/L | Standard Deviation 2 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 2 | 6.6 x10^9 cells/L | Standard Deviation 1.7 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 3 | 11.4 x10^9 cells/L | Standard Deviation 3.7 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 4 | 10.1 x10^9 cells/L | Standard Deviation 2.8 |
| Abdominal Hysterectomy | Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC)) | WBC time 5 | 9.2 x10^9 cells/L | Standard Deviation 2.3 |
p-value: <0.01ANOVA
Secondary
Health Economics (With 300 Robotic Procedures Annually)
Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.
Time frame: From the day of surgery until six weeks after surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Robotic Hysterectomy | Health Economics (With 300 Robotic Procedures Annually) | Direct costs per procedure | 65,728 Swedish crowns per procedure |
| Robotic Hysterectomy | Health Economics (With 300 Robotic Procedures Annually) | Indirect costs per procedure | 12,451 Swedish crowns per procedure |
| Robotic Hysterectomy | Health Economics (With 300 Robotic Procedures Annually) | Total costs (direct + indirect) per procedure | 78,179 Swedish crowns per procedure |
| Abdominal Hysterectomy | Health Economics (With 300 Robotic Procedures Annually) | Direct costs per procedure | 46,776 Swedish crowns per procedure |
| Abdominal Hysterectomy | Health Economics (With 300 Robotic Procedures Annually) | Indirect costs per procedure | 18,318 Swedish crowns per procedure |
| Abdominal Hysterectomy | Health Economics (With 300 Robotic Procedures Annually) | Total costs (direct + indirect) per procedure | 65,094 Swedish crowns per procedure |
p-value: 0.06t-test, 2 sided
Secondary
Health Economics (With 500 Robotic Procedures Annually)
Total costs (direct and indirect) for hospital stay and recovery period until six weeks postoperatively.
Time frame: From the day of surgery until six weeks after surgery.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Robotic Hysterectomy | Health Economics (With 500 Robotic Procedures Annually) | Direct costs per procedure | 61,862 Swedish crowns per procedure |
| Robotic Hysterectomy | Health Economics (With 500 Robotic Procedures Annually) | Indirect costs per procedure | 12,451 Swedish crowns per procedure |
| Robotic Hysterectomy | Health Economics (With 500 Robotic Procedures Annually) | Total costs (direct + indirect) per procedure | 74,313 Swedish crowns per procedure |
| Abdominal Hysterectomy | Health Economics (With 500 Robotic Procedures Annually) | Direct costs per procedure | 46,769 Swedish crowns per procedure |
| Abdominal Hysterectomy | Health Economics (With 500 Robotic Procedures Annually) | Indirect costs per procedure | 18,318 Swedish crowns per procedure |
| Abdominal Hysterectomy | Health Economics (With 500 Robotic Procedures Annually) | Total costs (direct + indirect) per procedure | 65,087 Swedish crowns per procedure |
p-value: 0.04t-test, 2 sided