Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04250883
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2020-01-29
Brief Title:
Low Pressure Pneumoperitoneum and Deep Neuromuscular Block Versus Standard Laparoscopy During Robot Assisted Radical Prostatectomy to Improve the Quality of Recovery and Immune Homeostasis Study Protocol for a Randomized Controlled Study
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Low Pressure Pneumoperitoneum and Deep Neuromuscular Blockade Versus Standard Laparoscopy During RARP to Improve the Quality of Recovery and Immune Homeostasis Study Protocol for a Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOVER-2
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-000411-79 | EUDRACT_NUMBER | None | None |