Acute Pain, Immune System Tolerance, Postoperative Complications, Quality of Life
Conditions
Brief summary
Intra-abdominal pressure (IAP) needed to create sufficient workspace during laparoscopic surgery affects the surrounding organs with ischemia-reperfusion injury and a systemic immune response. This effect is related to postoperative recovery, pain scores, opioid consumption, bowel function recovery, morbidity and possibly mortality. In clinical practice standard pressures of 12-16mmHg are applied instead of the lowest possible IAP, but accumulating evidence shows lower pressure pneumoperitoneum (PNP) (6-8mmHg) to be non-compromising for sufficient workspace, when combined with deep neuromuscular blockade (NMB) in a vast majority of patients. Therefore, low impact laparoscopy, meaning low pressure PNP facilitated by deep NMB, could be a valuable addition to Enhanced Recovery After Surgery (ERAS) Protocols. The use of low pressure PNP may also reduce hypoxic injury and the release of DAMPs and thereby contributing to a better preservation of innate immune function which may help to reduce the risk of infectious complications. The participants will be randomly assigned to one of the experimental groups with low impact laparoscopy or one of the control groups with standard laparoscopy.
Detailed description
Intra-abdominal pressure (IAP) needed to create sufficient workspace during laparoscopic surgery affects the surrounding organs with ischemia-reperfusion injury and a systemic immune response. This effect is related to postoperative recovery, pain scores, opioid consumption, bowel function recovery, morbidity and possibly mortality. Therefore, low impact laparoscopy, meaning low pressure PNP facilitated by deep NMB, could be a valuable addition to Enhanced Recovery After Surgery (ERAS) Protocols. The use of low pressure PNP may also reduce hypoxic injury and the release of DAMPs and thereby contributing to a better preservation of innate immune function which may help to reduce the risk of infectious complications. The participants will be randomly assigned to the experimental group 1: low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2)); 8 mmHg IAP after trocar introduction for perfusion measurement or the experimental group 2: low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2)); 12 mmHg IAP after trocar introduction for perfusion measurement, or control group 1: standard laparoscopy (standard pressure (12 mmHg) and moderate NMB (TOF 1-2)); 8 mmHg IAP after trocar introduction for perfusion measurement, or control group 2: standard laparoscopy (standard pressure (12 mmHg) and moderate NMB (TOF 1-2)); 12 mmHg IAP after trocar introduction for perfusion measurement. ICG injection will take place with starting pressure to quantify parietal peritoneum perfusion, and a parietal peritoneal biopsy will be taken. At the end of surgery, a second parietal peritoneum biopsy will be taken. NB: After introduction of the camera trocar, insufflation of carbon dioxide is titrated to an IAP of 8mmHg in group A and C, and 14 mmHg in group B and D. After placement of the last trocar the injection of ICG and video registration of peritoneum will take place, and a peritoneal biopsy will be taken. There after surgery will take place with an IAP of 14mmHg in the control groups (C and D), and an IAP of 8mmHg in the experimental groups (A and B). In the control groups (C and D) Pre- and postoperative a few questionnaires will be taken and blood withdrawals to evaluate the quality of recovery, and the immune response.
Interventions
8 mmHg
Deep NMB (PTC1-2)
OTHERStandard intra-abdominal pressure
14 mmHg
Moderate NMB (TOF 1-2)
Sponsors
Merck Sharp & Dohme LLC
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- Age ≥ 18 years * Undergoing elective robot assisted radical prostatectomy (RARP) * Obtained informed consent
Exclusion criteria
* Laparoscopic radical prostatectomy without robot assistance * Insufficient control of the Dutch language to read the patient information and to fill out de questionnaires * Neo-adjuvant chemotherapy * Chronic use of analgesics or psychotropic drugs * Use of NSAID's shorter than 5 days before surgery * Severe liver- or renal disease * Neuromuscular disease * Hyperthyroidism or thyroid adenomas * Deficiency of vitamin K dependent clotting factors or coagulopathy * Planned diagnostics or treatment with radioactive iodine \< 1 week after surgery * Indication for rapid sequence induction * BMI \>35kg/m2 * Known of suspected hypersensitivity to ICG, sodium iodide, iodine, rocuronium or sugammadex * Use of medication interfering with ICG absorption as listed in the summary of product characteristics (SPC); anticonvulsants, bisulphite compounds, haloperidol, heroin, meperidine, metamizol, methadone, morphium, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, cyclopropane, probencid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery - 40 Items Questionnaire Score (QoR-40) | at postoperative day 1 | 40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Nausea and Vomiting (PONV) | During hospital stay up to 3 days | Presence of symptoms yes/no |
| Perfusion Index of the Parietal Peritoneum | From ICG injection, up to 20 seconds | time to maximal intensity in seconds. (extracted from video registration). |
| Immune Response Represented by IL-10 | Pre-operative, postoperative day 1 and 12 | IL-10 response upon whole blood LPS stimulation |
| Immune Response Represented by IL-6 | Pre-operative, postoperative day 1 and 12 | IL-6 response upon whole blood LPS stimulation |
| Health Status With Short Form Survey (SF-36) | Measure pre-operative, on day 12 and at 3 months after surgery | Total score on a scale of 0-100 points. The lower the score the more disability. The higher the score the less disability. |
| Chronic Pain With McGill Pain Questionnaire (MPQ) | 3 months after surgery | Pain Rating index with a range from 0 (no pain) to 78 (severe pain) |
| Operating Conditions | During operation for up to 8 hours | surgical conditions with L-SRS 0 (extremely poor work field) to 5 (excellent work field) |
| Pain Score With NRS | Preset timepoints during hospital stay (1hr, 6hrs, 12hrs, day1), up to 3 days maximum. No measurements after discharge to home. | pain scores with NRS 0 (no pain) to 10 (severe pain) |
| Analgesia Use | During hospital stay up to 3 days | Cumulative opioid use in morphine equivalent (in mg) |
| Hospital Stay | from admission up to 3 days | length of hospital stay in days |
| Complications | Day of surgery untill 30days after surgery | Postoperative complications scored by Clavien Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss | During operation | during operation time in ml |
| Duration of Surgery | 0-350minutes | in minutes |
| Duration of Pneumoperitoneum | 0-350 minutes | in minutes |
Countries
Netherlands
Participant flow
Recruitment details
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.
Pre-assignment details
139 patients were excluded of which; 29 did not meet inclusion criteria, 99 declined to participate and 11 did not response on invitation.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Group: Low Impact Laparoscopy Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | 46 |
| Control Group: Standard Laparoscopy Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) | 50 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Experimental Group: Low Impact Laparoscopy | Control Group: Standard Laparoscopy | Total |
|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 6.6 | 67.9 years STANDARD_DEVIATION 5.1 | 66.4 years STANDARD_DEVIATION 6.1 |
| American Society of Anesthesiologist classification ASA 1 | 22 Participants | 15 Participants | 37 Participants |
| American Society of Anesthesiologist classification ASA 2 | 23 Participants | 31 Participants | 54 Participants |
| American Society of Anesthesiologist classification ASA 3 | 1 Participants | 4 Participants | 5 Participants |
| Body Mass Index (kg/m2) | 26.6 kg/m2 STANDARD_DEVIATION 2.9 | 27.4 kg/m2 STANDARD_DEVIATION 3.2 | 27.0 kg/m2 STANDARD_DEVIATION 3 |
| Comorbidity Cardiovascular No | 24 Participants | 18 Participants | 42 Participants |
| Comorbidity Cardiovascular Yes | 22 Participants | 32 Participants | 54 Participants |
| Comorbidity Diabetic No | 41 Participants | 47 Participants | 88 Participants |
| Comorbidity Diabetic Yes | 5 Participants | 3 Participants | 8 Participants |
| Comorbidity Liver impairment No | 46 Participants | 49 Participants | 95 Participants |
| Comorbidity Liver impairment Yes | 0 Participants | 1 Participants | 1 Participants |
| Comorbidity Neurologic No | 45 Participants | 48 Participants | 93 Participants |
| Comorbidity Neurologic Yes | 1 Participants | 2 Participants | 3 Participants |
| Comorbidity Pulmonal No | 44 Participants | 41 Participants | 85 Participants |
| Comorbidity Pulmonal Yes | 2 Participants | 9 Participants | 11 Participants |
| Comorbidity Renal impairment No | 46 Participants | 50 Participants | 96 Participants |
| Comorbidity Renal impairment Yes | 0 Participants | 0 Participants | 0 Participants |
| Operation - Pelvic lymph node dissection No | 25 Participants | 29 Participants | 54 Participants |
| Operation - Pelvic lymph node dissection Yes | 21 Participants | 21 Participants | 42 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Netherlands | 46 participants | 50 participants | 96 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 46 Participants | 50 Participants | 96 Participants |
| Tumor characteristic - Prostate Cancer specific antigen levels (ng/ml) | 55.13 ng/ml STANDARD_DEVIATION 40.4 | 61.74 ng/ml STANDARD_DEVIATION 47.1 | 58.5 ng/ml STANDARD_DEVIATION 43.9 |
| Tumor characteristics -Gleason score Score 6 | 10 Participants | 11 Participants | 21 Participants |
| Tumor characteristics -Gleason score Score 7 | 30 Participants | 32 Participants | 62 Participants |
| Tumor characteristics -Gleason score Score 8 | 3 Participants | 4 Participants | 7 Participants |
| Tumor characteristics -Gleason score Score 9 | 3 Participants | 3 Participants | 6 Participants |
| Tumor characteristics - ISUP score 1 | 10 Participants | 11 Participants | 21 Participants |
| Tumor characteristics - ISUP score 2 | 23 Participants | 25 Participants | 48 Participants |
| Tumor characteristics - ISUP score 3 | 8 Participants | 7 Participants | 15 Participants |
| Tumor characteristics - ISUP score 4 | 3 Participants | 4 Participants | 7 Participants |
| Tumor characteristics - ISUP score 5 | 3 Participants | 3 Participants | 6 Participants |
| Tumor characteristics - Prostate cancer classification T1c | 21 Participants | 23 Participants | 44 Participants |
| Tumor characteristics - Prostate cancer classification T2a-c | 19 Participants | 20 Participants | 39 Participants |
| Tumor characteristics - Prostate cancer classification T3a-c | 5 Participants | 4 Participants | 9 Participants |
| Tumor characteristics - Prostate cancer classification Unknown | 1 Participants | 3 Participants | 4 Participants |
| Tumor characteristics - Risk stratification High | 9 Participants | 11 Participants | 20 Participants |
| Tumor characteristics - Risk stratification Intermediate | 28 Participants | 30 Participants | 58 Participants |
| Tumor characteristics - Risk stratification Low | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 50 |
| other Total, other adverse events | 0 / 47 | 0 / 50 |
| serious Total, serious adverse events | 0 / 47 | 2 / 50 |
Outcome results
Primary
Quality of Recovery - 40 Items Questionnaire Score (QoR-40)
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Time frame: day 12 after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Quality of Recovery - 40 Items Questionnaire Score (QoR-40) | 179.1 score on a scale of 200 | Standard Deviation 15.8 |
| Control Group: Standard Laparoscopy | Quality of Recovery - 40 Items Questionnaire Score (QoR-40) | 180.0 score on a scale of 200 | Standard Deviation 15.1 |
p-value: 0.97Chi-squared, Corrected
Primary
Quality of Recovery - 40 Items Questionnaire Score (QoR-40)
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Time frame: Pre-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Quality of Recovery - 40 Items Questionnaire Score (QoR-40) | 186.6 score on a scale of 200 | Standard Deviation 8.7 |
| Control Group: Standard Laparoscopy | Quality of Recovery - 40 Items Questionnaire Score (QoR-40) | 186.8 score on a scale of 200 | Standard Deviation 11.5 |
Primary
Quality of Recovery - 40 Items Questionnaire Score (QoR-40)
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Time frame: at postoperative day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Quality of Recovery - 40 Items Questionnaire Score (QoR-40) | 162.7 score on a scale of 200 | Standard Deviation 21.5 |
| Control Group: Standard Laparoscopy | Quality of Recovery - 40 Items Questionnaire Score (QoR-40) | 167.6 score on a scale of 200 | Standard Deviation 23 |
p-value: 0.54Chi-squared, Corrected
Secondary
Analgesia Use
Cumulative opioid use in morphine equivalent (in mg)
Time frame: During hospital stay up to 3 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Analgesia Use | 1hour postoperative | 6.2 mg 'Morphine equivalent' | Standard Deviation 5.9 |
| Experimental Group: Low Impact Laparoscopy | Analgesia Use | Postoperative day 1 | 1.3 mg 'Morphine equivalent' | Standard Deviation 3.4 |
| Control Group: Standard Laparoscopy | Analgesia Use | 1hour postoperative | 5.9 mg 'Morphine equivalent' | Standard Deviation 4.8 |
| Control Group: Standard Laparoscopy | Analgesia Use | Postoperative day 1 | 0.9 mg 'Morphine equivalent' | Standard Deviation 2.1 |
Comparison: At 1 hourp-value: 0.89ANCOVA
Comparison: At postoperative day 1p-value: 0.49ANCOVA
Secondary
Chronic Pain With McGill Pain Questionnaire (MPQ)
Number of words Chosen according the user manual of the questionnaire
Time frame: 3 months after surgery
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Chronic Pain With McGill Pain Questionnaire (MPQ) | 3.2 number of words describing the pain | Standard Deviation 3.9 |
| Control Group: Standard Laparoscopy | Chronic Pain With McGill Pain Questionnaire (MPQ) | 4.2 number of words describing the pain | Standard Deviation 2.5 |
Secondary
Chronic Pain With McGill Pain Questionnaire (MPQ)
Pain Rating index with a range from 0 (no pain) to 78 (severe pain)
Time frame: 3 months after surgery
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Chronic Pain With McGill Pain Questionnaire (MPQ) | 7.3 score on a scale | Standard Deviation 5 |
| Control Group: Standard Laparoscopy | Chronic Pain With McGill Pain Questionnaire (MPQ) | 5.7 score on a scale | Standard Deviation 9.9 |
Comparison: Count of patients with or without pain at 3 months postoperativep-value: 0.84Chi-squared, Corrected
Comparison: Number of Words Chosenp-value: 0.89ANCOVA
Comparison: Pain Rating indexp-value: 0.98ANCOVA
Secondary
Complications
Postoperative complications scored by Clavien Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)
Time frame: Day of surgery untill 30days after surgery
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Complications | Grade 3 | Yes | 0 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications | Grade 1 | No | 42 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications | Grade 3 | No | 46 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications | Total | Yes | 8 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications | Grade 4 | Yes | 0 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications | Grade 2 | Yes | 4 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications | Grade 4 | No | 46 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications | Grade 1 | Yes | 4 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications | Grade 5 | Yes | 0 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications | Grade 2 | No | 42 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications | Grade 5 | No | 46 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications | Total | No | 38 Participants |
| Control Group: Standard Laparoscopy | Complications | Grade 5 | No | 50 Participants |
| Control Group: Standard Laparoscopy | Complications | Grade 1 | Yes | 1 Participants |
| Control Group: Standard Laparoscopy | Complications | Total | Yes | 10 Participants |
| Control Group: Standard Laparoscopy | Complications | Grade 1 | No | 49 Participants |
| Control Group: Standard Laparoscopy | Complications | Grade 2 | Yes | 6 Participants |
| Control Group: Standard Laparoscopy | Complications | Grade 2 | No | 44 Participants |
| Control Group: Standard Laparoscopy | Complications | Grade 3 | Yes | 2 Participants |
| Control Group: Standard Laparoscopy | Complications | Grade 3 | No | 48 Participants |
| Control Group: Standard Laparoscopy | Complications | Grade 4 | Yes | 1 Participants |
| Control Group: Standard Laparoscopy | Complications | Grade 4 | No | 49 Participants |
| Control Group: Standard Laparoscopy | Complications | Grade 5 | Yes | 0 Participants |
| Control Group: Standard Laparoscopy | Complications | Total | No | 40 Participants |
Comparison: Of Total complications within 30 days postoperativep-value: 0.92ANCOVA
Secondary
Health Status With Short Form Survey (SF-36)
Total score on a scale of 0-100 points. The lower the score the more disability. The higher the score the less disability.
Time frame: Measure pre-operative, on day 12 and at 3 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Health Status With Short Form Survey (SF-36) | Pre-operative | 81.1 score on a scale (0-100) | Standard Deviation 12.1 |
| Experimental Group: Low Impact Laparoscopy | Health Status With Short Form Survey (SF-36) | 12 days postoperative | 61.5 score on a scale (0-100) | Standard Deviation 14.1 |
| Experimental Group: Low Impact Laparoscopy | Health Status With Short Form Survey (SF-36) | 3 months postoperative | 73.7 score on a scale (0-100) | Standard Deviation 15.9 |
| Control Group: Standard Laparoscopy | Health Status With Short Form Survey (SF-36) | Pre-operative | 81.8 score on a scale (0-100) | Standard Deviation 11.5 |
| Control Group: Standard Laparoscopy | Health Status With Short Form Survey (SF-36) | 12 days postoperative | 64.3 score on a scale (0-100) | Standard Deviation 18.7 |
| Control Group: Standard Laparoscopy | Health Status With Short Form Survey (SF-36) | 3 months postoperative | 77.9 score on a scale (0-100) | Standard Deviation 15.5 |
p-value: 0.64Chi-squared, Corrected
p-value: 0.38Chi-squared, Corrected
Secondary
Hospital Stay
length of hospital stay in days
Time frame: from admission up to 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Hospital Stay | 1.3 Days | Standard Deviation 0.7 |
| Control Group: Standard Laparoscopy | Hospital Stay | 1.24 Days | Standard Deviation 0.48 |
p-value: 0.42ANCOVA
Secondary
Immune Response Represented by IL-10
IL-10 response upon whole blood LPS stimulation
Time frame: Pre-operative, postoperative day 1 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Immune Response Represented by IL-10 | preoperative | 6.43 pg/ml | Standard Deviation 15.76 |
| Experimental Group: Low Impact Laparoscopy | Immune Response Represented by IL-10 | postoperative day 1 | 11.72 pg/ml | Standard Deviation 15.45 |
| Experimental Group: Low Impact Laparoscopy | Immune Response Represented by IL-10 | postoperative day 12 | 7.24 pg/ml | Standard Deviation 15.55 |
| Control Group: Standard Laparoscopy | Immune Response Represented by IL-10 | preoperative | 7.25 pg/ml | Standard Deviation 12.45 |
| Control Group: Standard Laparoscopy | Immune Response Represented by IL-10 | postoperative day 1 | 13.94 pg/ml | Standard Deviation 17.01 |
| Control Group: Standard Laparoscopy | Immune Response Represented by IL-10 | postoperative day 12 | 8.89 pg/ml | Standard Deviation 13.98 |
Comparison: postoperative day 1p-value: 0.35ANCOVA
Comparison: at postoperative day 12p-value: 0.52ANCOVA
Secondary
Immune Response Represented by IL-6
IL-6 response upon whole blood LPS stimulation
Time frame: Pre-operative, postoperative day 1 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Immune Response Represented by IL-6 | preoperative | 6.60 pg/ml | Standard Deviation 22.83 |
| Experimental Group: Low Impact Laparoscopy | Immune Response Represented by IL-6 | postoperative day 1 | 20.07 pg/ml | Standard Deviation 27.37 |
| Experimental Group: Low Impact Laparoscopy | Immune Response Represented by IL-6 | postoperative day 12 | 8.26 pg/ml | Standard Deviation 22.9 |
| Control Group: Standard Laparoscopy | Immune Response Represented by IL-6 | preoperative | 8.67 pg/ml | Standard Deviation 19.45 |
| Control Group: Standard Laparoscopy | Immune Response Represented by IL-6 | postoperative day 1 | 24.38 pg/ml | Standard Deviation 26.67 |
| Control Group: Standard Laparoscopy | Immune Response Represented by IL-6 | postoperative day 12 | 11.95 pg/ml | Standard Deviation 20.98 |
Comparison: at postoperative day 1p-value: 0.99ANCOVA
Comparison: At postoperative day 12p-value: 0.3ANCOVA
Secondary
Operating Conditions
surgical conditions with L-SRS 0 (extremely poor work field) to 5 (excellent work field)
Time frame: During operation for up to 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Operating Conditions | 4.9 score on a scale of 0-5 | Standard Deviation 0.3 |
| Control Group: Standard Laparoscopy | Operating Conditions | 4.9 score on a scale of 0-5 | Standard Deviation 0.3 |
p-value: 0.9ANCOVA
Secondary
Pain Score With NRS
pain scores with NRS 0 (no pain) to 10 (severe pain)
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Pain Score With NRS | 1hour postoperative | 4.1 score on a scale of 10 | Standard Deviation 2.3 |
| Experimental Group: Low Impact Laparoscopy | Pain Score With NRS | 6hours postoperative | 2.3 score on a scale of 10 | Standard Deviation 1.1 |
| Experimental Group: Low Impact Laparoscopy | Pain Score With NRS | 12hours postoperative | 2.3 score on a scale of 10 | Standard Deviation 1.3 |
| Experimental Group: Low Impact Laparoscopy | Pain Score With NRS | Postoperative day 1 | 1.9 score on a scale of 10 | Standard Deviation 1.5 |
| Control Group: Standard Laparoscopy | Pain Score With NRS | Postoperative day 1 | 2.0 score on a scale of 10 | Standard Deviation 1.4 |
| Control Group: Standard Laparoscopy | Pain Score With NRS | 1hour postoperative | 3.9 score on a scale of 10 | Standard Deviation 2.2 |
| Control Group: Standard Laparoscopy | Pain Score With NRS | 12hours postoperative | 2.2 score on a scale of 10 | Standard Deviation 1.4 |
| Control Group: Standard Laparoscopy | Pain Score With NRS | 6hours postoperative | 2.3 score on a scale of 10 | Standard Deviation 1.4 |
Comparison: At 1 hourp-value: 0.68ANCOVA
Comparison: At 6 hoursp-value: 0.91ANCOVA
p-value: 0.73ANCOVA
p-value: 0.77ANCOVA
Secondary
Perfusion Index of the Parietal Peritoneum
time to maximal intensity in seconds. (extracted from video registration).
Time frame: From ICG injection, up to 20 seconds
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Perfusion Index of the Parietal Peritoneum | time to maximal intensity | 48.9 seconds | Standard Deviation 8.5 |
| Experimental Group: Low Impact Laparoscopy | Perfusion Index of the Parietal Peritoneum | Delta minimal and maximal intensity | 194.4 seconds | Standard Deviation 41.2 |
| Control Group: Standard Laparoscopy | Perfusion Index of the Parietal Peritoneum | time to maximal intensity | 53.2 seconds | Standard Deviation 10.2 |
| Control Group: Standard Laparoscopy | Perfusion Index of the Parietal Peritoneum | Delta minimal and maximal intensity | 169.7 seconds | Standard Deviation 62.8 |
Comparison: Time to maximal intensityp-value: 0.098ANCOVA
Comparison: Angle from minimal to maximal intensityp-value: 0.008ANCOVA
Comparison: Delta between minimal and maximal intensityp-value: 0.042ANCOVA
Secondary
Perfusion Index of the Parietal Peritoneum
Angle minimal to maximal, calculated from the slope of ICG fluorescence intensity (extracted from video registration).
Time frame: From ICG injection, up to 20 seconds
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Perfusion Index of the Parietal Peritoneum | 82.2 Degrees | Standard Deviation 2.6 |
| Control Group: Standard Laparoscopy | Perfusion Index of the Parietal Peritoneum | 78.5 Degrees | Standard Deviation 7.9 |
Secondary
Postoperative Nausea and Vomiting (PONV)
Presence of symptoms yes/no
Time frame: During hospital stay up to 3 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Postoperative Nausea and Vomiting (PONV) | 1hour postoperative | Yes | 1 Participants |
| Experimental Group: Low Impact Laparoscopy | Postoperative Nausea and Vomiting (PONV) | 1hour postoperative | No | 45 Participants |
| Experimental Group: Low Impact Laparoscopy | Postoperative Nausea and Vomiting (PONV) | Postoperative day 1 | Yes | 8 Participants |
| Experimental Group: Low Impact Laparoscopy | Postoperative Nausea and Vomiting (PONV) | Postoperative day 1 | No | 38 Participants |
| Control Group: Standard Laparoscopy | Postoperative Nausea and Vomiting (PONV) | Postoperative day 1 | No | 46 Participants |
| Control Group: Standard Laparoscopy | Postoperative Nausea and Vomiting (PONV) | 1hour postoperative | Yes | 0 Participants |
| Control Group: Standard Laparoscopy | Postoperative Nausea and Vomiting (PONV) | Postoperative day 1 | Yes | 4 Participants |
| Control Group: Standard Laparoscopy | Postoperative Nausea and Vomiting (PONV) | 1hour postoperative | No | 50 Participants |
Comparison: At 1 hourp-value: 0.63ANCOVA
Comparison: At postoperative day 1p-value: 0.19ANCOVA
Post Hoc
Complications Based on Infection
patient count
Time frame: 0-50 patients
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Complications Based on Infection | No | 3 Participants |
| Experimental Group: Low Impact Laparoscopy | Complications Based on Infection | Yes | 5 Participants |
| Control Group: Standard Laparoscopy | Complications Based on Infection | Yes | 10 Participants |
| Control Group: Standard Laparoscopy | Complications Based on Infection | No | 0 Participants |
p-value: 0.018ANCOVA
Other Pre-specified
Duration of Pneumoperitoneum
in minutes
Time frame: 0-350 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Duration of Pneumoperitoneum | 176.9 minutes | Standard Deviation 48.3 |
| Control Group: Standard Laparoscopy | Duration of Pneumoperitoneum | 159.8 minutes | Standard Deviation 56.4 |
p-value: 0.3ANCOVA
Other Pre-specified
Duration of Surgery
in minutes
Time frame: 0-350minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Duration of Surgery | 198.6 minutes | Standard Deviation 51.5 |
| Control Group: Standard Laparoscopy | Duration of Surgery | 183.9 minutes | Standard Deviation 58.7 |
p-value: 0.42ANCOVA
Other Pre-specified
Estimated Blood Loss
during operation time in ml
Time frame: During operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Group: Low Impact Laparoscopy | Estimated Blood Loss | 312.8 ml | Standard Deviation 333.6 |
| Control Group: Standard Laparoscopy | Estimated Blood Loss | 214.4 ml | Standard Deviation 229.1 |
p-value: 0.33ANCOVA