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

NCT04250883 | Completed Results DMC

• 2 other identifiers: NL72780.091.202020-000411-79
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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)

  at postoperative day 1

• 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)

  day 12 after surgery

• 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)

  Pre-operative

Secondary Outcomes (13)

• Health Status With Short Form Survey (SF-36)

  Measure pre-operative, on day 12 and at 3 months after surgery

• Chronic Pain With McGill Pain Questionnaire (MPQ)

  3 months after surgery

• Operating Conditions

  During operation for up to 8 hours

• Pain Score With NRS

  Preset timepoints during hospital stay (1hr, 6hrs, 12hrs, day1), up to 3 days maximum. No measurements after discharge to home.

• Postoperative Nausea and Vomiting (PONV)

  During hospital stay up to 3 days

Other Outcomes (3)

• Duration of Surgery

  0-350minutes

• Duration of Pneumoperitoneum

  0-350 minutes

• Estimated Blood Loss

  During operation

Study Arms (2)

Experimental group: Low Impact laparoscopy

EXPERIMENTAL

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

Other: Low intra-abdominal pressure; Other: Deep neuromuscular blockade (NMB)

Control group: Standard laparoscopy

ACTIVE COMPARATOR

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

Other: Standard intra-abdominal pressure; Other: Moderate neuromuscular blockade (NMB)

Interventions

Low intra-abdominal pressure OTHER

8 mmHg

Experimental group: Low Impact laparoscopy

Deep neuromuscular blockade (NMB) OTHER

Deep NMB (PTC1-2)

Experimental group: Low Impact laparoscopy

Standard intra-abdominal pressure OTHER

14 mmHg

Control group: Standard laparoscopy

Moderate neuromuscular blockade (NMB) OTHER

Moderate NMB (TOF 1-2)

Control group: Standard laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Age ≥ 18 years
• Undergoing elective robot assisted radical prostatectomy (RARP)
• Obtained informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Canisius Wilhelmina ziekenhuis

Nijmegen, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 38784993 RESULT

Related Links

• Publication of results in BJU international

MeSH Terms

Conditions

Postoperative Complications; Acute Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

For limitations and caveats we would like to refer you to the publication in BJU International: https://bjui-journals.onlinelibrary.wiley.com/doi/full/10.1111/bju.16397

Results Point of Contact

• Title: Dr. Michiel Warle
• Organization: Radboud umc

michielwarle@radboudumc.nl

024-3613808

Study Officials

• Michiel Warle, Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: December 24, 2020
• Primary Completion: December 9, 2021
• Study Completion: March 7, 2022
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)