Researchers from the Netherland have begun a clinical trial to investigate the effect of lower insufflation pressures facilitated by deep neuromuscular blockade (DNB) on patient outcomes after laparoscopic colorectal procedures. Specifically, the study will identify whether low pressure pneumoperitoneum (PNP) and DNB enhances recovery after colorectal laparoscopic surgery and whether this could be a valuable addition to the Enhanced Recovery After Surgery (ERAS) guidelines.
The study protocol, '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', was published in BMC Trials by authors from Radboud University Medical Center, Canisius Wilhelmina Hospital, Nijmegen and Martini General Hospital, Groningen, The Netherlands. Recruitment began in October 2018 and recruitment is expected to be completed by October 2020.
“There is considerable evidence to support superior surgical conditions during deep neuromuscular blockade, there is only a limited amount of studies investigating patient outcomes,” the investigators write. “Moreover, results are not always consistent between studies and vary between different types of laparoscopic surgery. This study will investigate the effect of low-pressure PNP facilitated by deep NMB on quality of recovery after laparoscopic colorectal surgery.”
The RECOVER study aims to recruit 204 patients who will be randomised in a 1:1 fashion to group A, low-pressure PNP (8mmHg) facilitated by deep neuromuscular blockade (post tetanic count of 1–2), or group B, normal-pressure PNP (12mmHg) with moderate neuromuscular blockade (train-of-four response of 1–2). The primary outcome is quality of recovery on postoperative day one, quantified by the Quality of Recovery-40 questionnaire.
Adult individuals scheduled for laparoscopic colorectal surgery with a primary colonic anastomosis are eligible for this study. Patients with a primary colostomy are not included in the study because this is likely associated with a significantly altered recovery process. Patients who have received neo-adjuvant chemotherapy are excluded because a sub-study investigating immune function will be performed in a subgroup of the participants.
The patient-reported outcome will be measured with a validated Dutch version of Quality of Recovery-40 questionnaire (QoR-40), consisting of 40 short questions across five domains: physical comfort (e.g., nausea, dizziness or shivering), emotional state (general well-being, feeling anxious or angry), physical independence (ability to wash and groom), psychological support (from hospital staff, family and friends), and pain (presence of moderate pain, severe pain, and pain in several locations). Patients rate these aspects of recovery on a scale of 1 to 5, resulting in a total score between 40 and 200. Separate scores on each subdomain will also be explored. When the clinical condition of the patient allows it, they self-complete the questionnaires. If this is not the case, they will be assisted by a nurse blinded to the treatment allocation.
“This multicentre randomised clinical trial will investigate the effect of low pressure PNP facilitated by deep NMB on quality of recovery after laparoscopic colorectal surgery. Moreover, the study will identify whether low pressure PNP and deep NMB could be a valuable addition to the ERAS guideline for colorectal surgery.
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