Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Impact Laparoscopy vs Standard Laparoscopy During Robot Assisted Radical Prostatectomy (RECOVER2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250883
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Radboud University

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.


Condition or disease Intervention/treatment Phase
Quality of Life Postoperative Complications Acute Pain Immune System Tolerance Other: Intra-abdominal pressure Other: Neuromuscular blockade (NMB) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Low Impact Laparoscopy vs Standard Laparoscopy During Robot Assisted Radical Prostatectomy to Improve the Quality of Recovery and Immune Homeostasis; a Randomized Controlled Study.
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : April 2022

Arm Intervention/treatment
Experimental: A. 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
Other: Intra-abdominal pressure
8 mmHg

Other: Neuromuscular blockade (NMB)
Deep NMB (PTC1-2)

Experimental: B. Experimental group 2
low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2)); 14 mmHg IAP after trocar introduction for perfusion measurement
Other: Neuromuscular blockade (NMB)
Deep NMB (PTC1-2)

Active Comparator: C. Control group 1
standard laparoscopy (standard pressure (14 mmHg) and moderate NMB (TOF 1-2)); 8 mmHg IAP after trocar introduction for perfusion measurement
Other: Intra-abdominal pressure
8 mmHg

No Intervention: D. Control group 2
standard laparoscopy (standard pressure (14 mmHg) and moderate NMB (TOF 1-2)); 14 mmHg IAP after trocar introduction for perfusion measurement



Primary Outcome Measures :
  1. Quality of recovery - 40 items questionnaire score (QoR-40) [ Time Frame: at postoperative day 1 ]
    40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)

  2. Immune response represented by IL-6 [ Time Frame: at postoperative day 7 ]
    IL-6 response upon whole blood LPS stimulation

  3. Immune response represented by IL-10 [ Time Frame: at postoperative day 7 ]
    IL-10 response upon whole blood LPS stimulation

  4. Perfusion index of the parietal peritoneum [ Time Frame: From ICG injection, up to 20 seconds ]
    calculated from the slope of ICG fluorescence intensity, and time to maximal intensity in seconds. (extracted from video registration).


Secondary Outcome Measures :
  1. Quality of recovery - 40 items questionnaire score (QoR-40) [ Time Frame: day 1 and day 10-12 ]
    40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)

  2. Health status with short form survey (SF-36) [ Time Frame: 1 day before, 10-12 days and 3 months after surgery ]
    The lower the score the more disability. The higher the score the less disability.

  3. Chronic pain with McGill pain questionnaire (MPQ) [ Time Frame: 3 months after surgery ]
    range from 0 (no pain) to 78 (severe pain)

  4. Pain score with VAS [ Time Frame: During hospital stay up to 3 days ]
    pain scores with VAS 0 (no pain) to 10 (severe pain)

  5. Analgesia use [ Time Frame: During hospital stay up to 3 days ]
    non-cumulative and cumulative opioid use per day in morphine equivalent

  6. PONV [ Time Frame: During hospital stay up to 3 days ]
    With PONV impact scale score o (no PONV) to 6 (extreme PONV)

  7. Hospital stay [ Time Frame: from admission up to 3 days ]
    length of hospital stay in days

  8. Postoperative recovery time [ Time Frame: From day of surgery up to 3 days ]
    time to reach discharge criteria in days

  9. Operating conditions [ Time Frame: During operation for up to 8 hours ]
    surgical conditions with L-SRS 0 (extremely poor work field) to 5 (excellent work field)

  10. Complications [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250883


Contacts
Layout table for location contacts
Contact: Gabby Reijnders-Boerboom, Drs. +31243617612 gabby.reijnders-boerboom@radboudumc.nl
Contact: Michiel Warle, Dr. +31243617612 michiel.warle@radboudumc.nl

Locations
Layout table for location information
Netherlands
Canisius Wilhelmina ziekenhuis
Nijmegen, Netherlands
Contact: Gabby Reijnders-Boerboom, Drs       gabby.reijnders-boerboom@radboudumc.nl   
Contact: Ivo Panhuizen, Dr.       i.panhuizen@cwz.nl   
Sponsors and Collaborators
Radboud University
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Principal Investigator: Michiel Warle, Dr. Radboud umc
Layout table for additonal information
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04250883    
Other Study ID Numbers: NL72780.091.20
2020-000411-79 ( EudraCT Number )
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be analyzed for publication. After that it belongs to Radboud umc where other researchers of Radboud umc may or may not include this database to their study. But there will be no active sharing

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Postoperative Complications
Acute Pain
Pathologic Processes
Pain
Neurologic Manifestations