Quality of LifeRECOVER-2NCT04250883
Low Pressure Pneumoperitoneum and Deep Neuromuscular Block vs. Standard During RARP to Improve Quality of Recovery; a Randomized Controlled Study.
A study testing Low intra-abdominal pressure, Deep neuromuscular blockade (NMB) and Standard intra-abdominal pressure in people with Quality of Life and Postoperative Complications, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Postoperative Complications, Acute Pain
- What is being tested?
- Low intra-abdominal pressure, Deep neuromuscular blockade (NMB) and Standard intra-abdominal pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Dec 2020to 7 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age ≥ 18 years
- Undergoing elective robot assisted radical prostatectomy (RARP)
- Obtained informed consent
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Low intra-abdominal pressure, Deep neuromuscular blockade (NMB), Standard intra-abdominal pressure, Moderate neuromuscular blockade (NMB)
- Medical subject headings
- Postoperative Complications, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intra-abdominal pressureOther
8 mmHg
Deep neuromuscular blockade (NMB)Other
Deep NMB (PTC1-2)
Standard intra-abdominal pressureOther
14 mmHg
Moderate neuromuscular blockade (NMB)Other
Moderate NMB (TOF 1-2)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: Low Impact laparoscopy | Experimental | low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2) Receives: 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) Receives: Other: Standard intra-abdominal pressure; Other: Moderate neuromuscular blockade (NMB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Pre-operative
Secondary outcomes (13)
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.
Measured: Measure pre-operative, on day 12 and at 3 months after surgery
Chronic Pain With McGill Pain Questionnaire (MPQ)
Pain Rating index with a range from 0 (no pain) to 78 (severe pain)
Measured: 3 months after surgery
Operating Conditions
surgical conditions with L-SRS 0 (extremely poor work field) to 5 (excellent work field)
Measured: During operation for up to 8 hours
Pain Score With NRS
pain scores with NRS 0 (no pain) to 10 (severe pain)
Measured: 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)
Presence of symptoms yes/no
Measured: During hospital stay up to 3 days
Analgesia Use
Cumulative opioid use in morphine equivalent (in mg)
Measured: During hospital stay up to 3 days
Hospital Stay
length of hospital stay in days
Measured: from admission up to 3 days
Complications
Postoperative complications scored by Clavien Dindo classification; grade 0 (no deviation from ideal) grade 5 (death of patient)
Measured: Day of surgery untill 30days after surgery
Perfusion Index of the Parietal Peritoneum
time to maximal intensity in seconds. (extracted from video registration).
Measured: From ICG injection, up to 20 seconds
Immune Response Represented by IL-10
IL-10 response upon whole blood LPS stimulation
Measured: Pre-operative, postoperative day 1 and 12
Immune Response Represented by IL-6
IL-6 response upon whole blood LPS stimulation
Measured: Pre-operative, postoperative day 1 and 12
Chronic Pain With McGill Pain Questionnaire (MPQ)
Number of words Chosen according the user manual of the questionnaire
Measured: 3 months after surgery
Perfusion Index of the Parietal Peritoneum
Angle minimal to maximal, calculated from the slope of ICG fluorescence intensity (extracted from video registration).
Measured: From ICG injection, up to 20 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start24 Dec 2020
- Primary completion9 Dec 2021
- Study completion7 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Michiel Warle, Dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250883
- Sponsor's protocol ID
- NL72780.091.20
- Other IDs
- 2020-000411-79
- Acronym
- RECOVER-2
- Status last verified
- Apr 2022
- First submitted
- 29 Jan 2020
- Last updated
- 5 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 38784993
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04250883
- Acronym / sponsor ID
- RECOVER-2 / NL72780.091.20
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 9 Dec 2021 (actual)
- Study completion
- 7 Mar 2022 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Experimental group: Low Impact laparoscopy | Experimental | Other: Low intra-abdominal pressure, Other: Deep neuromuscular blockade (NMB)low impact laparoscopy (low pressure (8 mmHg) and deep NMB (PTC 1-2) |
| Control group: Standard laparoscopy | Active comparator | Other: Standard intra-abdominal pressure, Other: Moderate neuromuscular blockade (NMB)standard laparoscopy (standard pressure (14 mmHg) and moderate NMB (TOF 1-2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - Age ≥ 18 years
- Undergoing elective robot assisted radical prostatectomy (RARP)
- Obtained informed consent
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intra-abdominal pressure8 mmHg | Other | Experimental group: Low Impact laparoscopy |
| Deep neuromuscular blockade (NMB)Deep NMB (PTC1-2) | Other | Experimental group: Low Impact laparoscopy |
| Standard intra-abdominal pressure14 mmHg | Other | Control group: Standard laparoscopy |
| Moderate neuromuscular blockade (NMB)Moderate NMB (TOF 1-2) | Other | Control group: Standard laparoscopy |
Primary outcome
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)
Quality of Recovery - 40 Items Questionnaire Score (QoR-40)
Time frame: day 12 after surgery
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
Quality of Recovery - 40 Items Questionnaire Score (QoR-40)
Time frame: Pre-operative
40 points (minimum: extremely poor quality of recovery) to 200 points (maximum: excellent quality of recovery)
13 secondary outcomes
Health Status With Short Form Survey (SF-36)
Time frame: Measure pre-operative, on day 12 and at 3 months after surgery
Chronic Pain With McGill Pain Questionnaire (MPQ)
Time frame: 3 months after surgery
Operating Conditions
Time frame: During operation for up to 8 hours
Pain Score With NRS
Time frame: 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)
Time frame: During hospital stay up to 3 days
Analgesia Use
Time frame: During hospital stay up to 3 days
Hospital Stay
Time frame: from admission up to 3 days
Complications
Time frame: Day of surgery untill 30days after surgery
Perfusion Index of the Parietal Peritoneum
Time frame: From ICG injection, up to 20 seconds
Immune Response Represented by IL-10
Time frame: Pre-operative, postoperative day 1 and 12
Immune Response Represented by IL-6
Time frame: Pre-operative, postoperative day 1 and 12
Chronic Pain With McGill Pain Questionnaire (MPQ)
Time frame: 3 months after surgery
Perfusion Index of the Parietal Peritoneum
Time frame: From ICG injection, up to 20 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 38784993Reijnders-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.
- Publication of results in BJU internationalLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michiel Warle, Dr. principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intra-abdominal pressure, Deep neuromuscular blockade (NMB) and Standard intra-abdominal pressure in people with Quality of Life and Postoperative Complications, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery - 40 Items Questionnaire Score (QoR-40) (time frame: at postoperative day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04250883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.