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PneumoperitoneumPhase 4RECOVERNCT03608436

The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery

A Phase 4 study testing Low pressure pneumoperitoneum and Rocuronium Bromide in people with Pneumoperitoneum and Neuromuscular Blockade, run by Radboud University Medical Center at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumoperitoneum, Neuromuscular Blockade, Surgery
What is being tested?
Low pressure pneumoperitoneum and Rocuronium Bromide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
3 sitesNetherlands
Study dates
24 Oct 2018to 3 Jun 2021
Phase
Phase 4
Are there results?
None posted in the registry

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

  • Scheduled for laparoscopic colorectal surgery with a primary anastomosis
  • Obtained informed consent
  • Age over 18 years

Who cannot join

  • Insufficient control of the Dutch language to read the patient information and to fill out the questionnaires
  • Primary colostomy
  • Neo-adjuvant chemotherapy
  • Chronic use of analgesics or psychotropic drugs
  • Use of NSAIDs shorter than 5 days before surgery
  • Known or suspected allergy to rocuronium of sugammadex
Show all 11Show fewer
  • Neuromuscular disease
  • Indication for rapid sequence induction
  • Severe liver- or renal disease (creatinine clearance <30ml/min)
  • BMI >35 kg/m²
  • Deficiency of vitamin K dependent clotting factors or coagulopathy

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • Martini general hospital

    Groningen

  • Canisius Wilhelmina Hospital

    Nijmegen, Gelderland, 6532SZ

  • Maxima Medisch Centrum

    Veldhoven

Other trials in Netherlands

About this study

Official title: RECOVER Study: the Effect of Low- Versus Normal Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on the Early Quality of Recovery With Perioperative Care According to the Enhanced Recovery Principles

Randomised controlled trial comparing the effect of low pressure pneumoperitoneum with deep neuromuscular block versus normal pressure pneumoperitoneum with moderate neuromuscular block during laparoscopic colorectal surgery on early quality of recovery.

Read the detailed description

Rationale: the laparoscopic approach reduced trauma as compared to open surgery, however, the pressure used to create a PNP with sufficient surgical workspace still leads to significant tissue injury. Prior studies show that the use of low-pressure pneumoperitoneum (PNP) during laparoscopic surgery reduced postoperative pain scores, cumulative opioid consumption and improved bowel function recovery. Deep neuromuscular blockade (NMB) as compared to moderate NMB decreases the amount of intra-abdominal pressure required to achieve similar surgical conditions and enables the use of low-pressure PNP without compromising the quality of the surgical field and patient safety. Therefore, the use of deep NMB with low-pressure PNP could be a significant addition to the conventional Enhanced Recovery After Surgery (ERAS) protocols.

Objective: to establish the relationship between the use of low pressure pneumoperitoneum with deep neuromuscular blockade and the early quality of recovery after laparoscopic colorectal surgery.

Study design: a multi-center, blinded, randomized controlled clinical trial.

Study population: adult individuals scheduled for laparoscopic colorectal surgery with a primary colonic anastomosis.

Intervention: participants will be randomly assigned in a 1:1 fashion to either the experimental group (group A): low pressure PNP (8 mmHg) with deep NMB (PTC 1-2) or the control group (group B): normal pressure PNP (12 mmHg) with moderate NMB (TOF count 1-2).

Primary endpoint: Quality of recovery score (QoR-40) 24 hours after surgery.

Secondary endpoints: QoR-40 score (day 3 and 7 after surgery), McGill pain- and RAND-36 score (1 day before and 3 months after surgery), pain scores, PONV, analgesia use, length of hospital stay, postoperative complications, surgical conditions and time to reach discharge criteria.

Being tested
Low pressure pneumoperitoneum, Rocuronium Bromide
Keywords
Quality of recovery, Laparoscopic surgery, Deep neuromuscular block, Low pressure pneumoperitoneum
Medical subject headings
Pneumoperitoneum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low pressure pneumoperitoneumProcedure or surgery

    Also called Low intra-abdominal pressure

    Lowering intra-abdominal pressure during laparoscopic surgery

  • Rocuronium BromideDrug

    Also called Deep muscle relaxation

    Deep (PTC 1-2) versus moderate (Tof count 1-2) neuromuscular block

Study groups in NCT03608436
Study groupRoleWhat they receive
Low pressure PNP, deep NMBExperimentalLow pressure pneumoperitoneum of 8 mmHg with deep neuromuscular block (post tetanic count of 1-2) reached by titration with continuous infusion of Rocuronium bromide.
Receives: Procedure: Low pressure pneumoperitoneum; Drug: Rocuronium Bromide
Normal pressure PNP, moderate NMBActive comparatorNormal pressure pneumoperitoneum of 12 mmHg with moderate neuromuscular block (TOF count of 1-2) reached by titration with bolus or continuous infusion of a low dose of Rocuronium bromide.
Receives: Drug: Rocuronium Bromide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total score on the Quality of Recovery-40 questionnaire

    The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200.

    Measured: 24 hours after surgery

Secondary outcomes (11)

  1. Total score on the Quality of Recovery-40 questionnaire

    The QoR-40 is a validated assessment tool for measuring a patient's self-assessed quality of recovery after surgery. It consists of 40 questions measuring 5 dimensions: patient support, comfort, emotions, physical independence and pain. Each item is rated on a scale of 1 to 5, giving a minimal score of 40 and a maximum score of 200.

    Measured: Day 3 and day 7 after surgery

  2. McGill pain Questionnaire

    Validated questionnaire for the assessment of quality and intensity of pain

    Measured: Upon admission and 3 months after surgery

  3. RAND-36 general health questionnaire

    Validated patient-reported survey of health

    Measured: Upon admission and 3 months after surgery

  4. Pain scores

    Pain at rest and pain upon movement (NRS 0-10), is pain acceptable yes or no, referred shoulder pain yes or no?

    Measured: 1, 8, 24, and 72 hours after surgery

  5. Post-operative nausea and vomiting (PONV)

    NRS 0-10

    Measured: 1, 8, 24 and 72 hours after surgery

  6. Cumulative use of analgesics and anti-emetics

    Total dose of opiates, other analgesics and anti-emetic drugs

    Measured: 1, 8, 24 and 72 hours after surgery

  7. Length of hospital stay

    Total number of days from admission to discharge after surgery (not including readmission)

    Measured: From date of admission until date of discharge from the hospital (usually several days), assessed up to 3 months.

  8. Surgical conditions

    Rating of the surgical conditions with the Leiden Surgical Rating Scale (L-SRS). The L-SRS is scored by the surgeon and ranges from 1-5 for quality of the surgical field. A score of 5 means optimal conditions: a wide laparoscopic field with no patient movements or muscle contractions, 1 means extremely poor conditions: the surgeon is unable to obtain a visible laparoscopic field because of inadequate muscle relaxation.

    Measured: Intraoperative: after introduction of the trocars and every 15 minutes until the end of the pneumoperitoneum.

  9. Intraoperative complications

    Complications during surgery graded according to the Clavien-Dindo classification

    Measured: During surgery

  10. Postoperative complications

    Postoperative complications

    Measured: Up to 3 months after surgery

  11. Time to reach discharge criteria

    Number of days to reach the following criteria after surgery: adequate pain control with oral medication, passage of flatus or defecation, intake of solid food tolerated, patient is mobilized and independent and patient accepts discharge.

    Measured: From date of surgery until date of actual discharge from the hospital (usually several days), assessed up to 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2018
  2. Study start24 Oct 2018
  3. Primary completion3 Mar 2021
  4. Study completion3 Jun 2021

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03608436
Sponsor's protocol ID
NL65290.091.18
Acronym
RECOVER
Status last verified
Mar 2021
First submitted
18 Jun 2018
Last updated
28 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Albers-Warle KI, Helder LS, Groh LA, Polat F, Panhuizen IF, Snoeck MMJ, Kox M, van Eijk L, Joosten LAB, Netea MG, Negishi Y, Mhlanga M, Keijzer C, Scheffer GJ, Warle MC. Postoperative Innate Immune Dysregulation, Proteomic, and Monocyte Epigenomic Changes After Colorectal Surgery: A Substudy of a Randomized Controlled Trial. Anesth Analg. 2025 Jan 1;140(1):185-196. doi: 10.1213/ANE.0000000000007297. Epub 2024 Oct 25.

    PubMed 39453841

  • Albers KI, Polat F, Panhuizen IF, Snoeck MMJ, Scheffer GJ, de Boer HD, Warle MC. The effect of low- versus normal-pressure pneumoperitoneum during laparoscopic colorectal surgery on the early quality of recovery with perioperative care according to the enhanced recovery principles (RECOVER): study protocol for a randomized controlled study. Trials. 2020 Jun 17;21(1):541. doi: 10.1186/s13063-020-04496-8.

    PubMed 32552782

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Low pressure pneumoperitoneum and Rocuronium Bromide in people with Pneumoperitoneum and Neuromuscular Blockade, run by Radboud University Medical Center at 3 sites 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 11 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Total score on the Quality of Recovery-40 questionnaire (time frame: 24 hours after surgery). 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 NCT03608436, which also lists 2 linked publications.

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 28 Oct 2021.

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