Clinical trial NCT03608436: The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumoperitoneum
Neuromuscular Blockade
Surgery
Keywords: Quality of recovery
Laparoscopic surgery
Deep neuromuscular block
Low pressure pneumoperitoneum
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2018-08-01
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total score on the Quality of Recovery-40 questionnaire
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Total score on the Quality of Recovery-40 questionnaire
timeFrame: Day 3 and day 7 after surgery
measure: McGill pain Questionnaire
timeFrame: Upon admission and 3 months after surgery
measure: RAND-36 general health questionnaire
timeFrame: Upon admission and 3 months after surgery
measure: Pain scores
timeFrame: 1, 8, 24, and 72 hours after surgery
measure: Post-operative nausea and vomiting (PONV)
timeFrame: 1, 8, 24 and 72 hours after surgery
measure: Cumulative use of analgesics and anti-emetics
timeFrame: 1, 8, 24 and 72 hours after surgery
measure: Length of hospital stay
timeFrame: From date of admission until date of discharge from the hospital (usually several days), assessed up to 3 months.
measure: Surgical conditions
timeFrame: Intraoperative: after introduction of the trocars and every 15 minutes until the end of the pneumoperitoneum.
measure: Intraoperative complications
timeFrame: During surgery
measure: Postoperative complications
timeFrame: Up to 3 months after surgery
measure: Time to reach discharge criteria
timeFrame: From date of surgery until date of actual discharge from the hospital (usually several days), assessed up to 3 months.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Hospital
state: Gelderland
city: Groningen
country: Netherlands
facility: Martini general hospital
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
Study officials:
affiliation: Radboud University Medical Center
name: Kim I Albers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Michiel C Warlé, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.