| 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) | | Posted | | Mean | Standard Deviation | score on a scale of 200 | | at postoperative day 1 | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000162.7± 21.5
- OG001167.6± 23.0
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Chi-squared, Corrected | | 0.54 | | | | | | | | | | | | | | Superiority | | |
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| 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) | | Posted | | Mean | Standard Deviation | score on a scale of 200 | | day 12 after surgery | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| 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) | | Posted | | Mean | Standard Deviation | score on a scale of 200 | | Pre-operative | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| 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. | | Posted | | Mean | Standard Deviation | score on a scale (0-100) | | Measure pre-operative, on day 12 and at 3 months after surgery | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| Secondary | Chronic Pain With McGill Pain Questionnaire (MPQ) | Pain Rating index with a range from 0 (no pain) to 78 (severe pain) | 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. | Posted | | Mean | Standard Deviation | score on a scale | | 3 months after surgery | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| Secondary | Operating Conditions | surgical conditions with L-SRS 0 (extremely poor work field) to 5 (excellent work field) | | Posted | | Mean | Standard Deviation | score on a scale of 0-5 | | During operation for up to 8 hours | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| Secondary | Pain Score With NRS | pain scores with NRS 0 (no pain) to 10 (severe pain) | Patients where in most cases discharged from the hospital on postoperative day 1 | Posted | | Mean | Standard Deviation | score on a scale of 10 | | Preset timepoints during hospital stay (1hr, 6hrs, 12hrs, day1), up to 3 days maximum. No measurements after discharge to home. | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| Secondary | Postoperative Nausea and Vomiting (PONV) | Presence of symptoms yes/no | | Posted | | Count of Participants | | Participants | | During hospital stay up to 3 days | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
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| Secondary | Analgesia Use | Cumulative opioid use in morphine equivalent (in mg) | | Posted | | Mean | Standard Deviation | mg 'Morphine equivalent' | | During hospital stay up to 3 days | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| Secondary | Hospital Stay | length of hospital stay in days | | Posted | | Mean | Standard Deviation | Days | | from admission up to 3 days | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| Secondary | Complications | Postoperative complications scored by Clavien Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient) | | Posted | | Count of Participants | | Participants | | Day of surgery untill 30days after surgery | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| Secondary | Perfusion Index of the Parietal Peritoneum | time to maximal intensity in seconds. (extracted from video registration). | | Posted | | Mean | Standard Deviation | seconds | | From ICG injection, up to 20 seconds | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
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| Secondary | Immune Response Represented by IL-10 | IL-10 response upon whole blood LPS stimulation | | Posted | | Mean | Standard Deviation | pg/ml | | Pre-operative, postoperative day 1 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
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| Secondary | Immune Response Represented by IL-6 | IL-6 response upon whole blood LPS stimulation | | Posted | | Mean | Standard Deviation | pg/ml | | Pre-operative, postoperative day 1 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
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| Other Pre-specified | Duration of Surgery | | | Posted | | Mean | Standard Deviation | minutes | | 0-350minutes | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
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| Other Pre-specified | Duration of Pneumoperitoneum | | | Posted | | Mean | Standard Deviation | minutes | | 0-350 minutes | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| Other Pre-specified | Estimated Blood Loss | during operation time in ml | | Posted | | Mean | Standard Deviation | ml | | During operation | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| Post-Hoc | Complications Based on Infection | | | Posted | | Count of Participants | | Participants | | 0-50 patients | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| Secondary | Chronic Pain With McGill Pain Questionnaire (MPQ) | Number of words Chosen according the user manual of the questionnaire | 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. | Posted | | Mean | Standard Deviation | number of words describing the pain | | 3 months after surgery | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
| |
| Secondary | Perfusion Index of the Parietal Peritoneum | Angle minimal to maximal, calculated from the slope of ICG fluorescence intensity (extracted from video registration). | | Posted | | Mean | Standard Deviation | Degrees | | From ICG injection, up to 20 seconds | | | | ID | Title | Description |
|---|
| OG000 | Experimental Group: Low Impact Laparoscopy | Using low intra-abdominal pressure (8 mmHg) and deep neuromuscular blockade (PTC1-2) | | OG001 | Control Group: Standard Laparoscopy | Using standard intra-abdominal pressure (14 mmHg) and moderate neuromuscular blockade (TOF 1-2) |
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