NCT03608436

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumoperitoneum
• Neuromuscular Blockade
• Surgery

Interventions

Type	Name	Description
PROCEDURE	Low pressure pneumoperitoneum	Lowering intra-abdominal pressure during laparoscopic surgery
DRUG	Rocuronium Bromide	Deep (PTC 1-2) versus moderate (Tof count 1-2) neuromuscular block

Timeline

• Start date: 2018-10-24
• Primary completion: 2021-03-03
• Completion: 2021-06-03
• First posted: 2018-08-01
• Last updated: 2021-10-28

Locations

3 sites across 1 country: Netherlands