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

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.

Study Overview

• Status: Completed
• Conditions: Pneumoperitoneum; Surgery; Neuromuscular Blockade
• Intervention / Treatment: Procedure: Low pressure pneumoperitoneum; Drug: Rocuronium Bromide

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.

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • Martini general hospital
  • Veldhoven, Netherlands
    • Máxima Medisch Centrum
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6532SZ
      • Canisius Wilhelmina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low pressure PNP, deep NMB; Low pressure pneumoperitoneum of 8 mmHg with deep neuromuscular block (post tetanic count of 1-2) reached by titration with continuous infusion of Rocuronium bromide.	Procedure: Low pressure pneumoperitoneum; Lowering intra-abdominal pressure during laparoscopic surgery; Other Names: Low intra-abdominal pressure; Drug: Rocuronium Bromide; Deep (PTC 1-2) versus moderate (Tof count 1-2) neuromuscular block; Other Names: Deep muscle relaxation
Active Comparator: Normal pressure PNP, moderate NMB; Normal 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.	Drug: Rocuronium Bromide; Deep (PTC 1-2) versus moderate (Tof count 1-2) neuromuscular block; Other Names: Deep muscle relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 3 and day 7 after surgery
McGill pain Questionnaire	Validated questionnaire for the assessment of quality and intensity of pain	Upon admission and 3 months after surgery
RAND-36 general health questionnaire	Validated patient-reported survey of health	Upon admission and 3 months after surgery
Pain scores	Pain at rest and pain upon movement (NRS 0-10), is pain acceptable yes or no, referred shoulder pain yes or no?	1, 8, 24, and 72 hours after surgery
Post-operative nausea and vomiting (PONV)	NRS 0-10	1, 8, 24 and 72 hours after surgery
Cumulative use of analgesics and anti-emetics	Total dose of opiates, other analgesics and anti-emetic drugs	1, 8, 24 and 72 hours after surgery
Length of hospital stay	Total number of days from admission to discharge after surgery (not including readmission)	From date of admission until date of discharge from the hospital (usually several days), assessed up to 3 months.
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.	Intraoperative: after introduction of the trocars and every 15 minutes until the end of the pneumoperitoneum.
Intraoperative complications	Complications during surgery graded according to the Clavien-Dindo classification	During surgery
Postoperative complications	Postoperative complications	Up to 3 months after surgery
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.	From date of surgery until date of actual discharge from the hospital (usually several days), assessed up to 3 months.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Michiel C Warlé, MD, PhD, Radboud University Medical Center; Principal Investigator: Kim I Albers, MD, Radboud University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2018
• Primary Completion (Actual): March 3, 2021
• Study Completion (Actual): June 3, 2021

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Quality of recovery; Low pressure pneumoperitoneum; Deep neuromuscular block
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anticonvulsants; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Bromides; Rocuronium
• Other Study ID Numbers: NL65290.091.18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No