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NCT Number: NCT03608436

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

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.

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Key information

Conditions

Pneumoperitoneum Digestive System Diseases Neuromuscular Blockade Peritoneal Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Canisius Wilhelmina Hospital, Nijmegen, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Low Pressure Pneumoperitoneum

Procedure

Lowering intra-abdominal pressure during laparoscopic surgery

Other names: Low intra-abdominal pressure

Rocuronium bromide

Drug

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

Other names: Deep muscle relaxation

Primary outcomes

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

    Time frame: 24 hours after surgery

    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.

Secondary outcomes

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

    Time frame: Day 3 and day 7 after surgery

    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.

  2. McGill pain Questionnaire

    Time frame: Upon admission and 3 months after surgery

    Validated questionnaire for the assessment of quality and intensity of pain

  3. RAND-36 general health questionnaire

    Time frame: Upon admission and 3 months after surgery

    Validated patient-reported survey of health

  4. Pain scores

    Time frame: 1, 8, 24, and 72 hours after surgery

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

  5. Post-operative nausea and vomiting (PONV)

    Time frame: 1, 8, 24 and 72 hours after surgery

    NRS 0-10

  6. Cumulative use of analgesics and anti-emetics

    Time frame: 1, 8, 24 and 72 hours after surgery

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

  7. Length of hospital stay

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

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

  8. Surgical conditions

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

    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.

  9. Intraoperative complications

    Time frame: During surgery

    Complications during surgery graded according to the Clavien-Dindo classification

  10. Postoperative complications

    Time frame: Up to 3 months after surgery

    Postoperative complications

  11. Time to reach discharge criteria

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

    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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: RECOVER

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 1, 2018
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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