Low Pressure Pneumoperitoneum and Deep Neuromuscular Block vs. Standard During RARP to Improve Quality of Recovery; a Randomized Controlled Study.

NCT ID: NCT04250883

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-24
• Study Completion Date: 2022-03-07

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.

Conditions

Quality of Life; Postoperative Complications; Acute Pain; Immune System Tolerance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Experimental group: Low Impact laparoscopy

low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2)

Group Type: EXPERIMENTAL

Low intra-abdominal pressure

Intervention Type: OTHER

8 mmHg

Deep neuromuscular blockade (NMB)

Intervention Type: OTHER

Deep NMB (PTC1-2)

Control group: Standard laparoscopy

standard laparoscopy (standard pressure (14 mmHg) and moderate NMB (TOF 1-2)

Group Type: ACTIVE_COMPARATOR

Standard intra-abdominal pressure

Intervention Type: OTHER

14 mmHg

Moderate neuromuscular blockade (NMB)

Intervention Type: OTHER

Moderate NMB (TOF 1-2)

Interventions

Low intra-abdominal pressure

8 mmHg

Intervention Type: OTHER

Deep neuromuscular blockade (NMB)

Deep NMB (PTC1-2)

Intervention Type: OTHER

Standard intra-abdominal pressure

14 mmHg

Intervention Type: OTHER

Moderate neuromuscular blockade (NMB)

Moderate NMB (TOF 1-2)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michiel Warle, Dr.

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Canisius Wilhelmina ziekenhuis

Nijmegen, , Netherlands

Countries

Netherlands

References

Reijnders-Boerboom GTJA, Jacobs LMC, Helder LS, Panhuizen IF, Brouwer MPJ, Albers KI, Loonen T, Scheffer GJ, Keijzer C, van Basten JA, Warle MC. Recovery and immune function after low pressure pneumoperitoneum during robot-assisted radical prostatectomy: a randomised controlled trial. BJU Int. 2024 Sep;134(3):416-425. doi: 10.1111/bju.16397. Epub 2024 May 24.

Reference Type: RESULT

PMID: 38784993 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/38784993/

Publication of results in BJU international

Other Identifiers

2020-000411-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NL72780.091.20

Identifier Type: -

Identifier Source: org_study_id