Taylor H E, Simons K, Willmott C, Smith R E R, Bramley D E P
1Department Anaesthesia, Pain and Perioperative Medicine, Western Health, 160 Gordon Street, Footscray, Melbourne, VIC 3011 Australia.
2Centre for Epidemiology and Biostatistics, Melbourne School of Population Health, University of Melbourne, Melbourne, Australia.
Pilot Feasibility Stud. 2019 Jul 22;5:94. doi: 10.1186/s40814-019-0477-7. eCollection 2019.
Oxygen consumption after surgery is increased in response to the tissue trauma sustained intra-operatively and the subsequent systemic inflammatory response that ensues. The cardio-respiratory system must match the tissue oxygen and metabolic requirements; otherwise, peri-operative complications may occur. Existing data is several decades old. The primary objective of this feasibility study was to determine the ease of recruiting participants and collecting relevant data to assess the extent and duration of increased oxygen consumption and post-operative complications after major abdominal surgery in contemporaneous times.
One hundred patients scheduled for elective colorectal surgery requiring a bowel resection were screened to test specific feasibility criteria relating to ease of recruitment, duration of post-operative stay, ease of data collection, and drop-out rates. A calibrated metabolic cart was used to obtain unblinded pre-operative resting oxygen consumption recordings. The metabolic cart was then used to obtain post-operative oxygen consumption readings on days 1 to 5 as long as the participant remained as an inpatient. At the time of the oxygen consumption reading, a Post-Operative Morbidity Survey score (POMS) was calculated. Feasibility outcomes chosen a priori were that at least one participant would be recruited every 2 weeks from the pre-admission colorectal clinic, at least 10% of potential subjects screened would be enrolled, at least 80% of recruited participants would have a minimum post-operative stay of 2 nights, a minimum of 3 consecutive days of oxygen consumption data would be collected for each subject, at least 8 of 9 POMS score domains would be completed per participant per day and the drop-out rate would be no greater than 10%. We deemed that screening 100 patients would be sufficient to test our feasibility outcomes.
Twelve participants completed the protocol. All pre-specified feasibility criteria were met. No increase in post-operative oxygen consumption was observed in this feasibility cohort.
The protocol and experiences gained from this feasibility study could be used to plan a larger study to better define changes in post-operative oxygen consumption after major abdominal surgery utilizing current surgical techniques.
术后耗氧量会因术中遭受的组织创伤以及随后引发的全身炎症反应而增加。心肺系统必须满足组织的氧气和代谢需求；否则，可能会发生围手术期并发症。现有数据已有数十年历史。这项可行性研究的主要目的是确定招募参与者并收集相关数据的难易程度，以评估当代大型腹部手术后耗氧量增加的程度和持续时间以及术后并发症情况。
对100例计划进行择期结直肠手术且需要进行肠切除的患者进行筛查，以测试与招募难易程度、术后住院时间、数据收集难易程度和退出率相关的特定可行性标准。使用校准后的代谢推车获取未设盲的术前静息耗氧量记录。只要参与者仍为住院患者，术后第1至5天就使用代谢推车获取耗氧量读数。在读取耗氧量时，计算术后发病率调查评分（POMS）。预先确定的可行性结果是，从入院前的结直肠诊所每2周至少招募1名参与者，至少10%的筛查潜在受试者将被纳入研究，至少80%的招募参与者术后至少住院2晚，为每个受试者至少收集连续3天的耗氧量数据，每位参与者每天至少完成9个POMS评分领域中的8个，且退出率不超过10%。我们认为筛查100名患者足以测试我们的可行性结果。
12名参与者完成了方案。所有预先指定的可行性标准均得到满足。在这个可行性队列中未观察到术后耗氧量增加。
该可行性研究的方案和经验可用于规划一项更大规模的研究，以更好地利用当前手术技术确定大型腹部手术后术后耗氧量的变化情况。
