腹腔镜结直肠手术中低气压与正常气压气腹对基于加速康复原则的围手术期护理的早期康复质量的影响（RECOVER）：一项随机对照研究的研究方案。
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.
机构信息
Department of Surgery and Anesthesiology, Radboud University Medical Center, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, The Netherlands.
Department of Surgery, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands.
出版信息
Trials. 2020 Jun 17;21(1):541. doi: 10.1186/s13063-020-04496-8.
BACKGROUND
There is increasing evidence for the use of lower insufflation pressures during laparoscopic surgery. Deep neuromuscular blockade allows for a safe reduction in intra-abdominal pressure without compromising the quality of the surgical field. While there is considerable evidence to support superior surgical conditions during deep neuromuscular blockade, there is only a limited amount of studies investigating patient outcomes. 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 pneumoperitoneum facilitated by deep NMB on quality of recovery after laparoscopic colorectal surgery.
METHODS
The RECOVER study is a multicenter double-blinded randomized controlled trial consisting of 204 patients who will be randomized in a 1:1 fashion to group A, low-pressure pneumoperitoneum (8 mmHg) facilitated by deep neuromuscular blockade (post tetanic count of 1-2), or group B, normal-pressure pneumoperitoneum (12 mmHg) with moderate neuromuscular blockade (train-of-four response of 1-2). The primary outcome is quality of recovery on postoperative day 1, quantified by the Quality of Recovery-40 questionnaire.
DISCUSSION
Few studies have investigated the effect of lower insufflation pressures facilitated by deep neuromuscular blockade on patient outcomes after laparoscopic colorectal procedures. This study will identify whether low pressure pneumoperitoneum and deep neuromuscular blockade will enhance recovery after colorectal laparoscopic surgery and, moreover, if this could be a valuable addition to the Enhanced Recovery After Surgery guidelines.
TRIAL REGISTRATION
EudraCT 2018-001485-42. Registered on April 9, 2018. Clinicaltrials.govNCT03608436. Registered on July 30, 2018.
背景
越来越多的证据表明，在腹腔镜手术中使用较低的充气压力。深度神经肌肉阻滞允许安全地降低腹内压，而不会影响手术区域的质量。虽然有大量证据支持深度神经肌肉阻滞下的手术条件更优，但只有有限的研究调查患者的结局。此外，研究结果之间并不总是一致，并且在不同类型的腹腔镜手术之间也存在差异。本研究将调查在深度神经肌肉阻滞下通过低压气腹对腹腔镜结直肠手术后恢复质量的影响。
方法
RECOVER 研究是一项多中心、双盲、随机对照试验，纳入 204 例患者，将以 1:1 的比例随机分为 A 组（深度神经肌肉阻滞下的低压气腹[8mmHg]，强直刺激计数为 1-2）或 B 组（中度神经肌肉阻滞下的正常压气腹[12mmHg]，强直刺激计数为 1-2）。主要结局是术后第 1 天的恢复质量，通过 Quality of Recovery-40 问卷进行量化。
讨论
很少有研究调查深度神经肌肉阻滞下较低充气压力对腹腔镜结直肠手术后患者结局的影响。本研究将确定低压气腹和深度神经肌肉阻滞是否会增强结直肠腹腔镜手术后的恢复，并且这是否可以成为手术后快速康复指南的有益补充。
试验注册
EudraCT 2018-001485-42。于 2018 年 4 月 9 日注册。Clinicaltrials.govNCT03608436。于 2018 年 7 月 30 日注册。
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