Pilot and Feasibility Studies (Jul 2019)
A feasibility study to investigate post-operative oxygen consumption (POpOC) after colorectal surgery requiring bowel resection
Abstract
Abstract Background 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. Methods 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. Results 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. Conclusions 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.
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