Trial Outcomes & Findings for Low Pressure Pneumoperitoneum and Deep Neuromuscular Block vs. Standard During RARP to Improve Quality of Recovery; a Randomized Controlled Study. (NCT NCT04250883)
NCT ID: NCT04250883
Last Updated: 2025-02-05
Results Overview
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
at postoperative day 1
Results posted on
2025-02-05
Participant Flow
This blinded, randomized controlled trial was performed at the Canisius Wilhelmina Hospital in Nijmegen. Patients with at least stage T1c prostate cancer scheduled for RARP were randomized to the experimental group with low IAP (8 mmHg) facilitated by deep NMB (PTC 1-2) or the control group with standard IAP (14 mmHg) with moderate NMB (TOF 1-2). From December 2020 to December 2021, 236 patients were assessed for eligibility and 97 were included for randomization.
139 patients were excluded of which; 29 did not meet inclusion criteria, 99 declined to participate and 11 did not response on invitation.
Participant milestones
| Measure |
Experimental Group: Low Impact Laparoscopy
the use of low intra-abdominal pressure (8 mmHg), and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
The use of standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
50
|
|
Overall Study
Quality of Recovery Questionnaire at 3 Months
|
46
|
50
|
|
Overall Study
COMPLETED
|
46
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Experimental Group: Low Impact Laparoscopy
the use of low intra-abdominal pressure (8 mmHg), and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
The use of standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.9 years
STANDARD_DEVIATION 6.6 • n=46 Participants
|
67.9 years
STANDARD_DEVIATION 5.1 • n=50 Participants
|
66.4 years
STANDARD_DEVIATION 6.1 • n=96 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=46 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=46 Participants
|
50 Participants
n=50 Participants
|
96 Participants
n=96 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Netherlands
|
46 participants
n=46 Participants
|
50 participants
n=50 Participants
|
96 participants
n=96 Participants
|
|
Body Mass Index (kg/m2)
|
26.6 kg/m2
STANDARD_DEVIATION 2.9 • n=46 Participants
|
27.4 kg/m2
STANDARD_DEVIATION 3.2 • n=50 Participants
|
27.0 kg/m2
STANDARD_DEVIATION 3.0 • n=96 Participants
|
|
American Society of Anesthesiologist classification
ASA 1
|
22 Participants
n=46 Participants
|
15 Participants
n=50 Participants
|
37 Participants
n=96 Participants
|
|
American Society of Anesthesiologist classification
ASA 2
|
23 Participants
n=46 Participants
|
31 Participants
n=50 Participants
|
54 Participants
n=96 Participants
|
|
American Society of Anesthesiologist classification
ASA 3
|
1 Participants
n=46 Participants
|
4 Participants
n=50 Participants
|
5 Participants
n=96 Participants
|
|
Comorbidity
Cardiovascular · Yes
|
22 Participants
n=46 Participants
|
32 Participants
n=50 Participants
|
54 Participants
n=96 Participants
|
|
Comorbidity
Cardiovascular · No
|
24 Participants
n=46 Participants
|
18 Participants
n=50 Participants
|
42 Participants
n=96 Participants
|
|
Comorbidity
Pulmonal · Yes
|
2 Participants
n=46 Participants
|
9 Participants
n=50 Participants
|
11 Participants
n=96 Participants
|
|
Comorbidity
Pulmonal · No
|
44 Participants
n=46 Participants
|
41 Participants
n=50 Participants
|
85 Participants
n=96 Participants
|
|
Comorbidity
Neurologic · Yes
|
1 Participants
n=46 Participants
|
2 Participants
n=50 Participants
|
3 Participants
n=96 Participants
|
|
Comorbidity
Neurologic · No
|
45 Participants
n=46 Participants
|
48 Participants
n=50 Participants
|
93 Participants
n=96 Participants
|
|
Comorbidity
Diabetic · Yes
|
5 Participants
n=46 Participants
|
3 Participants
n=50 Participants
|
8 Participants
n=96 Participants
|
|
Comorbidity
Diabetic · No
|
41 Participants
n=46 Participants
|
47 Participants
n=50 Participants
|
88 Participants
n=96 Participants
|
|
Comorbidity
Renal impairment · Yes
|
0 Participants
n=46 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=96 Participants
|
|
Comorbidity
Renal impairment · No
|
46 Participants
n=46 Participants
|
50 Participants
n=50 Participants
|
96 Participants
n=96 Participants
|
|
Comorbidity
Liver impairment · Yes
|
0 Participants
n=46 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=96 Participants
|
|
Comorbidity
Liver impairment · No
|
46 Participants
n=46 Participants
|
49 Participants
n=50 Participants
|
95 Participants
n=96 Participants
|
|
Tumor characteristics - Risk stratification
Low
|
9 Participants
n=46 Participants
|
9 Participants
n=50 Participants
|
18 Participants
n=96 Participants
|
|
Tumor characteristics - Risk stratification
Intermediate
|
28 Participants
n=46 Participants
|
30 Participants
n=50 Participants
|
58 Participants
n=96 Participants
|
|
Tumor characteristics - Risk stratification
High
|
9 Participants
n=46 Participants
|
11 Participants
n=50 Participants
|
20 Participants
n=96 Participants
|
|
Tumor characteristics - Prostate cancer classification
T1c
|
21 Participants
n=46 Participants
|
23 Participants
n=50 Participants
|
44 Participants
n=96 Participants
|
|
Tumor characteristics - Prostate cancer classification
T2a-c
|
19 Participants
n=46 Participants
|
20 Participants
n=50 Participants
|
39 Participants
n=96 Participants
|
|
Tumor characteristics - Prostate cancer classification
T3a-c
|
5 Participants
n=46 Participants
|
4 Participants
n=50 Participants
|
9 Participants
n=96 Participants
|
|
Tumor characteristics - Prostate cancer classification
Unknown
|
1 Participants
n=46 Participants
|
3 Participants
n=50 Participants
|
4 Participants
n=96 Participants
|
|
Tumor characteristics -Gleason score
Score 6
|
10 Participants
n=46 Participants
|
11 Participants
n=50 Participants
|
21 Participants
n=96 Participants
|
|
Tumor characteristics -Gleason score
Score 7
|
30 Participants
n=46 Participants
|
32 Participants
n=50 Participants
|
62 Participants
n=96 Participants
|
|
Tumor characteristics -Gleason score
Score 8
|
3 Participants
n=46 Participants
|
4 Participants
n=50 Participants
|
7 Participants
n=96 Participants
|
|
Tumor characteristics -Gleason score
Score 9
|
3 Participants
n=46 Participants
|
3 Participants
n=50 Participants
|
6 Participants
n=96 Participants
|
|
Tumor characteristics - ISUP score
1
|
10 Participants
n=46 Participants
|
11 Participants
n=50 Participants
|
21 Participants
n=96 Participants
|
|
Tumor characteristics - ISUP score
2
|
23 Participants
n=46 Participants
|
25 Participants
n=50 Participants
|
48 Participants
n=96 Participants
|
|
Tumor characteristics - ISUP score
3
|
8 Participants
n=46 Participants
|
7 Participants
n=50 Participants
|
15 Participants
n=96 Participants
|
|
Tumor characteristics - ISUP score
4
|
3 Participants
n=46 Participants
|
4 Participants
n=50 Participants
|
7 Participants
n=96 Participants
|
|
Tumor characteristics - ISUP score
5
|
3 Participants
n=46 Participants
|
3 Participants
n=50 Participants
|
6 Participants
n=96 Participants
|
|
Tumor characteristic - Prostate Cancer specific antigen levels (ng/ml)
|
55.13 ng/ml
STANDARD_DEVIATION 40.4 • n=46 Participants
|
61.74 ng/ml
STANDARD_DEVIATION 47.1 • n=50 Participants
|
58.5 ng/ml
STANDARD_DEVIATION 43.9 • n=96 Participants
|
|
Operation - Pelvic lymph node dissection
Yes
|
21 Participants
n=46 Participants
|
21 Participants
n=50 Participants
|
42 Participants
n=96 Participants
|
|
Operation - Pelvic lymph node dissection
No
|
25 Participants
n=46 Participants
|
29 Participants
n=50 Participants
|
54 Participants
n=96 Participants
|
PRIMARY outcome
Timeframe: at postoperative day 140 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Quality of Recovery - 40 Items Questionnaire Score (QoR-40)
|
162.7 score on a scale of 200
Standard Deviation 21.5
|
167.6 score on a scale of 200
Standard Deviation 23.0
|
PRIMARY outcome
Timeframe: day 12 after surgery40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Quality of Recovery - 40 Items Questionnaire Score (QoR-40)
|
179.1 score on a scale of 200
Standard Deviation 15.8
|
180.0 score on a scale of 200
Standard Deviation 15.1
|
PRIMARY outcome
Timeframe: Pre-operative40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Quality of Recovery - 40 Items Questionnaire Score (QoR-40)
|
186.6 score on a scale of 200
Standard Deviation 8.7
|
186.8 score on a scale of 200
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Measure pre-operative, on day 12 and at 3 months after surgeryTotal score on a scale of 0-100 points. The lower the score the more disability. The higher the score the less disability.
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Health Status With Short Form Survey (SF-36)
Pre-operative
|
81.1 score on a scale (0-100)
Standard Deviation 12.1
|
81.8 score on a scale (0-100)
Standard Deviation 11.5
|
|
Health Status With Short Form Survey (SF-36)
12 days postoperative
|
61.5 score on a scale (0-100)
Standard Deviation 14.1
|
64.3 score on a scale (0-100)
Standard Deviation 18.7
|
|
Health Status With Short Form Survey (SF-36)
3 months postoperative
|
73.7 score on a scale (0-100)
Standard Deviation 15.9
|
77.9 score on a scale (0-100)
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: 3 months after surgeryPopulation: 43 participants in de experimental group, and 45 participants in the control group fulfilled the questionnaire. Only 6 participants per group had pain at 3 months after surgery.
Pain Rating index with a range from 0 (no pain) to 78 (severe pain)
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=6 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=6 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Chronic Pain With McGill Pain Questionnaire (MPQ)
|
7.3 score on a scale
Standard Deviation 5.0
|
5.7 score on a scale
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: During operation for up to 8 hourssurgical conditions with L-SRS 0 (extremely poor work field) to 5 (excellent work field)
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Operating Conditions
|
4.9 score on a scale of 0-5
Standard Deviation 0.3
|
4.9 score on a scale of 0-5
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Preset timepoints during hospital stay (1hr, 6hrs, 12hrs, day1), up to 3 days maximum. No measurements after discharge to home.Population: Patients where in most cases discharged from the hospital on postoperative day 1
pain scores with NRS 0 (no pain) to 10 (severe pain)
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Pain Score With NRS
1hour postoperative
|
4.1 score on a scale of 10
Standard Deviation 2.3
|
3.9 score on a scale of 10
Standard Deviation 2.2
|
|
Pain Score With NRS
6hours postoperative
|
2.3 score on a scale of 10
Standard Deviation 1.1
|
2.3 score on a scale of 10
Standard Deviation 1.4
|
|
Pain Score With NRS
12hours postoperative
|
2.3 score on a scale of 10
Standard Deviation 1.3
|
2.2 score on a scale of 10
Standard Deviation 1.4
|
|
Pain Score With NRS
Postoperative day 1
|
1.9 score on a scale of 10
Standard Deviation 1.5
|
2.0 score on a scale of 10
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: During hospital stay up to 3 daysPresence of symptoms yes/no
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Postoperative Nausea and Vomiting (PONV)
1hour postoperative · Yes
|
1 Participants
|
0 Participants
|
|
Postoperative Nausea and Vomiting (PONV)
1hour postoperative · No
|
45 Participants
|
50 Participants
|
|
Postoperative Nausea and Vomiting (PONV)
Postoperative day 1 · Yes
|
8 Participants
|
4 Participants
|
|
Postoperative Nausea and Vomiting (PONV)
Postoperative day 1 · No
|
38 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: During hospital stay up to 3 daysCumulative opioid use in morphine equivalent (in mg)
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Analgesia Use
1hour postoperative
|
6.2 mg 'Morphine equivalent'
Standard Deviation 5.9
|
5.9 mg 'Morphine equivalent'
Standard Deviation 4.8
|
|
Analgesia Use
Postoperative day 1
|
1.3 mg 'Morphine equivalent'
Standard Deviation 3.4
|
0.9 mg 'Morphine equivalent'
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: from admission up to 3 dayslength of hospital stay in days
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Hospital Stay
|
1.3 Days
Standard Deviation 0.7
|
1.24 Days
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: Day of surgery untill 30days after surgeryPostoperative complications scored by Clavien Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Complications
Total · Yes
|
8 Participants
|
10 Participants
|
|
Complications
Total · No
|
38 Participants
|
40 Participants
|
|
Complications
Grade 1 · Yes
|
4 Participants
|
1 Participants
|
|
Complications
Grade 1 · No
|
42 Participants
|
49 Participants
|
|
Complications
Grade 2 · Yes
|
4 Participants
|
6 Participants
|
|
Complications
Grade 2 · No
|
42 Participants
|
44 Participants
|
|
Complications
Grade 3 · Yes
|
0 Participants
|
2 Participants
|
|
Complications
Grade 3 · No
|
46 Participants
|
48 Participants
|
|
Complications
Grade 4 · Yes
|
0 Participants
|
1 Participants
|
|
Complications
Grade 4 · No
|
46 Participants
|
49 Participants
|
|
Complications
Grade 5 · Yes
|
0 Participants
|
0 Participants
|
|
Complications
Grade 5 · No
|
46 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: From ICG injection, up to 20 secondstime to maximal intensity in seconds. (extracted from video registration).
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=39 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=40 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Perfusion Index of the Parietal Peritoneum
time to maximal intensity
|
48.9 seconds
Standard Deviation 8.5
|
53.2 seconds
Standard Deviation 10.2
|
|
Perfusion Index of the Parietal Peritoneum
Delta minimal and maximal intensity
|
194.4 seconds
Standard Deviation 41.2
|
169.7 seconds
Standard Deviation 62.8
|
SECONDARY outcome
Timeframe: Pre-operative, postoperative day 1 and 12IL-10 response upon whole blood LPS stimulation
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=47 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Immune Response Represented by IL-10
preoperative
|
6.43 pg/ml
Standard Deviation 15.76
|
7.25 pg/ml
Standard Deviation 12.45
|
|
Immune Response Represented by IL-10
postoperative day 1
|
11.72 pg/ml
Standard Deviation 15.45
|
13.94 pg/ml
Standard Deviation 17.01
|
|
Immune Response Represented by IL-10
postoperative day 12
|
7.24 pg/ml
Standard Deviation 15.55
|
8.89 pg/ml
Standard Deviation 13.98
|
SECONDARY outcome
Timeframe: Pre-operative, postoperative day 1 and 12IL-6 response upon whole blood LPS stimulation
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=47 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Immune Response Represented by IL-6
preoperative
|
6.60 pg/ml
Standard Deviation 22.83
|
8.67 pg/ml
Standard Deviation 19.45
|
|
Immune Response Represented by IL-6
postoperative day 1
|
20.07 pg/ml
Standard Deviation 27.37
|
24.38 pg/ml
Standard Deviation 26.67
|
|
Immune Response Represented by IL-6
postoperative day 12
|
8.26 pg/ml
Standard Deviation 22.9
|
11.95 pg/ml
Standard Deviation 20.98
|
SECONDARY outcome
Timeframe: 3 months after surgeryPopulation: 43 participants in de experimental group, and 45 participants in the control group fulfilled the questionnaire. Only 6 participants per group had pain at 3 months after surgery.
Number of words Chosen according the user manual of the questionnaire
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=6 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=6 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Chronic Pain With McGill Pain Questionnaire (MPQ)
|
3.2 number of words describing the pain
Standard Deviation 3.9
|
4.2 number of words describing the pain
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: From ICG injection, up to 20 secondsAngle minimal to maximal, calculated from the slope of ICG fluorescence intensity (extracted from video registration).
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=39 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=40 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Perfusion Index of the Parietal Peritoneum
|
82.2 Degrees
Standard Deviation 2.6
|
78.5 Degrees
Standard Deviation 7.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-350minutesin minutes
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Duration of Surgery
|
198.6 minutes
Standard Deviation 51.5
|
183.9 minutes
Standard Deviation 58.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-350 minutesin minutes
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Duration of Pneumoperitoneum
|
176.9 minutes
Standard Deviation 48.3
|
159.8 minutes
Standard Deviation 56.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During operationduring operation time in ml
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=46 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Estimated Blood Loss
|
312.8 ml
Standard Deviation 333.6
|
214.4 ml
Standard Deviation 229.1
|
POST_HOC outcome
Timeframe: 0-50 patientspatient count
Outcome measures
| Measure |
Experimental Group: Low Impact Laparoscopy
n=8 Participants
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=10 Participants
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Complications Based on Infection
Yes
|
5 Participants
|
10 Participants
|
|
Complications Based on Infection
No
|
3 Participants
|
0 Participants
|
Adverse Events
Experimental Group: Low Impact Laparoscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group: Standard Laparoscopy
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Group: Low Impact Laparoscopy
n=47 participants at risk
Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2)
|
Control Group: Standard Laparoscopy
n=50 participants at risk
Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2)
|
|---|---|---|
|
Infections and infestations
Small abces in smal pelvic with paralytic ileus
|
0.00%
0/47 • From operation up to 3 months postoperative
according definitions of clinicaltrials.gov
|
2.0%
1/50 • Number of events 1 • From operation up to 3 months postoperative
according definitions of clinicaltrials.gov
|
|
Renal and urinary disorders
Blow out kidney
|
0.00%
0/47 • From operation up to 3 months postoperative
according definitions of clinicaltrials.gov
|
2.0%
1/50 • Number of events 1 • From operation up to 3 months postoperative
according definitions of clinicaltrials.gov
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place