Trial Outcomes & Findings for Robot Assisted Laparoscopic Hysterectomy vs. Abdominal Hysterectomy in Endometrial Cancer (NCT NCT01526655)
NCT ID: NCT01526655
Last Updated: 2024-04-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42
Results posted on
2024-04-18
Participant Flow
One patient withdrew consent prior to surgery in the control group (abdominal hysterectomy) and received the standard treatment.
Participant milestones
| Measure |
Robotic Hysterectomy
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Robotic Hysterectomy
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Robotic Hysterectomy
n=25 Participants
Robot assisted laparoscopic total hysterectomy
Robot assisted laparoscopic hysterectomy: Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
n=25 Participants
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
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Body mass index
BMI 25-29.9
|
8 Participants
n=25 Participants
|
10 Participants
n=25 Participants
|
18 Participants
n=50 Participants
|
|
Body mass index
BMI 30-35
|
6 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
11 Participants
n=50 Participants
|
|
Body mass index
BMI > 35
|
4 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
6 Participants
n=50 Participants
|
|
Parity
|
2 births
n=25 Participants
|
2 births
n=25 Participants
|
2 births
n=50 Participants
|
|
Smokers
|
4 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
4 Participants
n=50 Participants
|
|
Previous laparotomy
|
13 Participants
n=25 Participants
|
8 Participants
n=25 Participants
|
21 Participants
n=50 Participants
|
|
Comorbidity
Cardiovascular disease
|
10 Participants
n=25 Participants
|
11 Participants
n=25 Participants
|
21 Participants
n=50 Participants
|
|
Comorbidity
Pulmonary disease
|
3 Participants
n=25 Participants
|
3 Participants
n=25 Participants
|
6 Participants
n=50 Participants
|
|
Comorbidity
Diabetes mellitus
|
0 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
4 Participants
n=50 Participants
|
|
Comorbidity
Previous breast cancer
|
3 Participants
n=25 Participants
|
3 Participants
n=25 Participants
|
6 Participants
n=50 Participants
|
|
Current medication
Antidepressant/sedative
|
2 Participants
n=25 Participants
|
3 Participants
n=25 Participants
|
5 Participants
n=50 Participants
|
|
Current medication
Analgesics
|
5 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
7 Participants
n=50 Participants
|
|
ASA classification (American Society of Anesthesiologists physical status classification system)
Class I
|
9 Participants
n=25 Participants
|
11 Participants
n=25 Participants
|
20 Participants
n=50 Participants
|
|
ASA classification (American Society of Anesthesiologists physical status classification system)
Class II
|
15 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
28 Participants
n=50 Participants
|
|
ASA classification (American Society of Anesthesiologists physical status classification system)
Class III
|
1 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=50 Participants
|
|
EQ-5D health index preoperatively (EuroQol Group form five dimensions)
|
0.81 score on a scale
n=25 Participants
|
0.82 score on a scale
n=25 Participants
|
0.81 score on a scale
n=50 Participants
|
|
HADS Anxiety (Hospital Anxiety and Depression Scale)
No anxiety
|
13 Participants
n=25 Participants
|
15 Participants
n=25 Participants
|
28 Participants
n=50 Participants
|
|
HADS Anxiety (Hospital Anxiety and Depression Scale)
Mild-moderate anxiety
|
9 Participants
n=25 Participants
|
6 Participants
n=25 Participants
|
15 Participants
n=50 Participants
|
|
HADS Anxiety (Hospital Anxiety and Depression Scale)
Severe anxiety
|
3 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
7 Participants
n=50 Participants
|
|
HADS Depression (Hospital Anxiety and Depression Scale)
No depression
|
21 Participants
n=25 Participants
|
21 Participants
n=25 Participants
|
42 Participants
n=50 Participants
|
|
HADS Depression (Hospital Anxiety and Depression Scale)
Mild-moderate depression
|
4 Participants
n=25 Participants
|
4 Participants
n=25 Participants
|
8 Participants
n=50 Participants
|
|
PSQ score (Pain Sensitivity Questionnaire score)
PSQ total score (range 0-10)
|
2.9 score on a scale (0-10)
n=25 Participants
|
3.3 score on a scale (0-10)
n=25 Participants
|
3.1 score on a scale (0-10)
n=50 Participants
|
|
Sex/Gender, Customized
Female
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
25 Participants
n=25 Participants
|
25 Participants
n=25 Participants
|
50 Participants
n=50 Participants
|
|
Body mass index
|
28.2 kg/m^2
n=25 Participants
|
28.0 kg/m^2
n=25 Participants
|
28.1 kg/m^2
n=50 Participants
|
|
Body mass index
BMI <25
|
7 Participants
n=25 Participants
|
8 Participants
n=25 Participants
|
15 Participants
n=50 Participants
|
|
Age, Continuous
|
68 years
n=25 Participants
|
67 years
n=25 Participants
|
67 years
n=50 Participants
|
|
PSQ score (Pain Sensitivity Questionnaire score)
PSQ minor score (range 0-10)
|
2.1 score on a scale (0-10)
n=25 Participants
|
2.3 score on a scale (0-10)
n=25 Participants
|
2.3 score on a scale (0-10)
n=50 Participants
|
|
PSQ score (Pain Sensitivity Questionnaire score)
PSQ moderate score(range 0-10)
|
4.4 score on a scale (0-10)
n=25 Participants
|
4.4 score on a scale (0-10)
n=25 Participants
|
4.4 score on a scale (0-10)
n=50 Participants
|
PRIMARY outcome
Timeframe: Days 0, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35, 42Population: 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.
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.
Outcome measures
| Measure |
Robotic Hysterectomy
n=25 Participants
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
n=24 Participants
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 2
|
0.74 scores on a scale
Standard Deviation 0.19
|
0.56 scores on a scale
Standard Deviation 0.31
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 3
|
0.73 scores on a scale
Standard Deviation 0.19
|
0.59 scores on a scale
Standard Deviation 0.28
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 4
|
0.77 scores on a scale
Standard Deviation 0.19
|
0.63 scores on a scale
Standard Deviation 0.30
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 5
|
0.83 scores on a scale
Standard Deviation 0.18
|
0.64 scores on a scale
Standard Deviation 0.31
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 0
|
0.34 scores on a scale
Standard Deviation 0.40
|
0.30 scores on a scale
Standard Deviation 0.53
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 1
|
0.66 scores on a scale
Standard Deviation 0.24
|
0.48 scores on a scale
Standard Deviation 0.40
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 6
|
0.84 scores on a scale
Standard Deviation 0.17
|
0.67 scores on a scale
Standard Deviation 0.25
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 7
|
0.83 scores on a scale
Standard Deviation 0.22
|
0.66 scores on a scale
Standard Deviation 0.29
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 14
|
0.88 scores on a scale
Standard Deviation 0.11
|
0.73 scores on a scale
Standard Deviation 0.22
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 21
|
0.91 scores on a scale
Standard Deviation 0.12
|
0.71 scores on a scale
Standard Deviation 0.31
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 28
|
0.92 scores on a scale
Standard Deviation 0.10
|
0.76 scores on a scale
Standard Deviation 0.29
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 35
|
0.93 scores on a scale
Standard Deviation 0.12
|
0.82 scores on a scale
Standard Deviation 0.26
|
|
Health Related Quality of Life (HRQoL)
EQ-5D Day 42
|
0.95 scores on a scale
Standard Deviation 0.09
|
0.86 scores on a scale
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Robotic Hysterectomy
n=25 Participants
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
n=24 Participants
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))
hsCRP time 2
|
2.7 mg/L
Standard Deviation 2.6
|
4.7 mg/L
Standard Deviation 11.4
|
|
Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))
hsCRP time 3
|
2.3 mg/L
Standard Deviation 2.3
|
3.5 mg/L
Standard Deviation 6.7
|
|
Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))
hsCRP time 4
|
29.0 mg/L
Standard Deviation 29.4
|
52.3 mg/L
Standard Deviation 27.0
|
|
Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))
hsCRP time 5
|
46.3 mg/L
Standard Deviation 49.8
|
75.4 mg/L
Standard Deviation 43.7
|
|
Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))
hsCRP time 6
|
10.5 mg/L
Standard Deviation 8.6
|
9.3 mg/L
Standard Deviation 8.6
|
|
Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))
hsCRP time 7
|
2.9 mg/L
Standard Deviation 2.6
|
1.9 mg/L
Standard Deviation 1.5
|
|
Changes in Biomarkers for Tissue Damage (C-reactive Protein (hsCRP))
hsCRP time 1
|
2.5 mg/L
Standard Deviation 2.1
|
6.0 mg/L
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Robotic Hysterectomy
n=25 Participants
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
n=24 Participants
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))
WBC time 1
|
6.7 x10^9 cells/L
Standard Deviation 1.7
|
7.7 x10^9 cells/L
Standard Deviation 2.1
|
|
Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))
WBC time 2
|
6.2 x10^9 cells/L
Standard Deviation 1.7
|
6.6 x10^9 cells/L
Standard Deviation 1.7
|
|
Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))
WBC time 3
|
6.8 x10^9 cells/L
Standard Deviation 3.0
|
11.4 x10^9 cells/L
Standard Deviation 3.7
|
|
Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))
WBC time 4
|
9.4 x10^9 cells/L
Standard Deviation 3.3
|
10.1 x10^9 cells/L
Standard Deviation 2.8
|
|
Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))
WBC time 5
|
7.2 x10^9 cells/L
Standard Deviation 2.3
|
9.2 x10^9 cells/L
Standard Deviation 2.3
|
|
Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))
WBC time 6
|
7.2 x10^9 cells/L
Standard Deviation 2.0
|
7.6 x10^9 cells/L
Standard Deviation 2.0
|
|
Changes in Biomarkers for Tissue Damage (White Blood Cells (WBC))
WBC time 7
|
6.5 x10^9 cells/L
Standard Deviation 1.5
|
6.8 x10^9 cells/L
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Robotic Hysterectomy
n=25 Participants
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
n=24 Participants
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))
IL-6 time 1
|
15.0 pg/ml
Standard Deviation 29.8
|
10.9 pg/ml
Standard Deviation 19.0
|
|
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))
IL-6 time 2
|
15.7 pg/ml
Standard Deviation 29.0
|
9.6 pg/ml
Standard Deviation 13.8
|
|
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))
IL-6 time 3
|
21.0 pg/ml
Standard Deviation 28.7
|
47.6 pg/ml
Standard Deviation 24.5
|
|
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))
IL-6 time 4
|
28.0 pg/ml
Standard Deviation 31.0
|
37.9 pg/ml
Standard Deviation 19.0
|
|
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))
IL-6 time 5
|
15.3 pg/ml
Standard Deviation 21.8
|
17.3 pg/ml
Standard Deviation 9.4
|
|
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))
IL-6 time 6
|
18.4 pg/ml
Standard Deviation 31.2
|
10.0 pg/ml
Standard Deviation 12.1
|
|
Changes in Biomarkers for Tissue Damage (Interleukin 6 (IL-6))
IL-6 time 7
|
13.1 pg/ml
Standard Deviation 25.7
|
12.2 pg/ml
Standard Deviation 28.8
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Robotic Hysterectomy
n=25 Participants
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
n=24 Participants
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))
CK time 1
|
1.8 µkat/L
Standard Deviation 1.1
|
1.6 µkat/L
Standard Deviation 1.1
|
|
Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))
CK time 2
|
1.9 µkat/L
Standard Deviation 1.1
|
1.6 µkat/L
Standard Deviation 1.0
|
|
Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))
CK time 3
|
1.5 µkat/L
Standard Deviation 0.9
|
2.5 µkat/L
Standard Deviation 1.0
|
|
Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))
CK time 4
|
3.3 µkat/L
Standard Deviation 2.5
|
6.2 µkat/L
Standard Deviation 4.9
|
|
Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))
CK time 5
|
3.0 µkat/L
Standard Deviation 2.4
|
4.5 µkat/L
Standard Deviation 2.1
|
|
Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))
CK time 6
|
1.0 µkat/L
Standard Deviation 0.6
|
0.9 µkat/L
Standard Deviation 0.6
|
|
Changes in Biomarkers for Tissue Damage (Creatin Kinase (CK))
CK time 7
|
1.6 µkat/L
Standard Deviation 1.1
|
1.3 µkat/L
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Robotic Hysterectomy
n=25 Participants
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
n=24 Participants
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Changes in Biomarkers for Tissue Damage (Cortisol)
Cortisol time 1
|
273.4 nmol/L
Standard Deviation 75.0
|
266.0 nmol/L
Standard Deviation 123.2
|
|
Changes in Biomarkers for Tissue Damage (Cortisol)
Cortisol time 2
|
489.0 nmol/L
Standard Deviation 137.0
|
510.1 nmol/L
Standard Deviation 131.2
|
|
Changes in Biomarkers for Tissue Damage (Cortisol)
Cortisol time 3
|
301.0 nmol/L
Standard Deviation 267.0
|
533.2 nmol/L
Standard Deviation 249.0
|
|
Changes in Biomarkers for Tissue Damage (Cortisol)
Cortisol time 4
|
392.0 nmol/L
Standard Deviation 201.0
|
383.0 nmol/L
Standard Deviation 178.1
|
|
Changes in Biomarkers for Tissue Damage (Cortisol)
Cortisol time 5
|
358.1 nmol/L
Standard Deviation 128.0
|
379.0 nmol/L
Standard Deviation 125.4
|
|
Changes in Biomarkers for Tissue Damage (Cortisol)
Cortisol time 6
|
309.1 nmol/L
Standard Deviation 98.0
|
331.0 nmol/L
Standard Deviation 76.0
|
|
Changes in Biomarkers for Tissue Damage (Cortisol)
Cortisol time 7
|
307.0 nmol/L
Standard Deviation 129.0
|
331.1 nmol/L
Standard Deviation 125.4
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Robotic Hysterectomy
n=25 Participants
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
n=24 Participants
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Health Economics (With 300 Robotic Procedures Annually)
Direct costs per procedure
|
65,728 Swedish crowns per procedure
|
46,776 Swedish crowns per procedure
|
|
Health Economics (With 300 Robotic Procedures Annually)
Indirect costs per procedure
|
12,451 Swedish crowns per procedure
|
18,318 Swedish crowns per procedure
|
|
Health Economics (With 300 Robotic Procedures Annually)
Total costs (direct + indirect) per procedure
|
78,179 Swedish crowns per procedure
|
65,094 Swedish crowns per procedure
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Robotic Hysterectomy
n=25 Participants
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
n=24 Participants
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Health Economics (With 500 Robotic Procedures Annually)
Direct costs per procedure
|
61,862 Swedish crowns per procedure
|
46,769 Swedish crowns per procedure
|
|
Health Economics (With 500 Robotic Procedures Annually)
Indirect costs per procedure
|
12,451 Swedish crowns per procedure
|
18,318 Swedish crowns per procedure
|
|
Health Economics (With 500 Robotic Procedures Annually)
Total costs (direct + indirect) per procedure
|
74,313 Swedish crowns per procedure
|
65,087 Swedish crowns per procedure
|
Adverse Events
Robotic Hysterectomy
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Abdominal Hysterectomy
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Robotic Hysterectomy
n=25 participants at risk
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
n=24 participants at risk
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Blood and lymphatic system disorders
Reoperation vaginal vault bleeding
|
0.00%
0/25 • From the day of surgery until six weeks postoperatively.
|
4.2%
1/24 • Number of events 1 • From the day of surgery until six weeks postoperatively.
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.00%
0/25 • From the day of surgery until six weeks postoperatively.
|
4.2%
1/24 • Number of events 1 • From the day of surgery until six weeks postoperatively.
|
Other adverse events
| Measure |
Robotic Hysterectomy
n=25 participants at risk
Robot assisted laparoscopic total hysterectomy
|
Abdominal Hysterectomy
n=24 participants at risk
Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision
|
|---|---|---|
|
Infections and infestations
Wound complications
|
0.00%
0/25 • From the day of surgery until six weeks postoperatively.
|
25.0%
6/24 • Number of events 6 • From the day of surgery until six weeks postoperatively.
|
|
Nervous system disorders
Neuralgia
|
20.0%
5/25 • Number of events 5 • From the day of surgery until six weeks postoperatively.
|
4.2%
1/24 • Number of events 1 • From the day of surgery until six weeks postoperatively.
|
|
Infections and infestations
Urinary tract infection
|
8.0%
2/25 • Number of events 2 • From the day of surgery until six weeks postoperatively.
|
12.5%
3/24 • Number of events 3 • From the day of surgery until six weeks postoperatively.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/25 • From the day of surgery until six weeks postoperatively.
|
4.2%
1/24 • Number of events 1 • From the day of surgery until six weeks postoperatively.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/25 • From the day of surgery until six weeks postoperatively.
|
8.3%
2/24 • Number of events 2 • From the day of surgery until six weeks postoperatively.
|
|
Blood and lymphatic system disorders
Vaginal vault hematoma
|
0.00%
0/25 • From the day of surgery until six weeks postoperatively.
|
4.2%
1/24 • Number of events 1 • From the day of surgery until six weeks postoperatively.
|
|
Blood and lymphatic system disorders
Red blood cell transfusion
|
0.00%
0/25 • From the day of surgery until six weeks postoperatively.
|
4.2%
1/24 • Number of events 1 • From the day of surgery until six weeks postoperatively.
|
|
Surgical and medical procedures
Spinal punction not possible
|
4.0%
1/25 • Number of events 1 • From the day of surgery until six weeks postoperatively.
|
8.3%
2/24 • Number of events 2 • From the day of surgery until six weeks postoperatively.
|
|
Surgical and medical procedures
Intubation difficulties
|
0.00%
0/25 • From the day of surgery until six weeks postoperatively.
|
4.2%
1/24 • Number of events 1 • From the day of surgery until six weeks postoperatively.
|
Additional Information
Professor Dr. Preben Kjölhede
Department of Obstetrics and Gynaecology, and Department of Clinical and Experimental Medicine, Linköpings universitet (LIU), Sweden
Phone: +4638231188
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place