A large number of postoperative pulmonary outcome measures have been used, but most are poorly defined. Our four recommended outcome measures include a new definition of postoperative pulmonary complications, incorporating an assessment of severity. These definitions will meet the needs of most clinical effectiveness trials of treatments to improve postoperative pulmonary outcomes.
Background
Minimally invasive surgery (MIS) and enhanced recovery protocols (ERPs) have improved postoperative recovery and shortened length of hospital stay (LOS). Telemedicine technology has potential to improve outcomes and patient experience further. This study was designed to determine whether the combination of MIS, ERP and a structured telemedicine programme (TeleRecovery) could shorten total 30‐day LOS by 50 per cent.
Methods
This was a phase II prospective RCT at a large academic medical centre. Eligible patients aged 18–80 years undergoing minimally invasive colorectal resection using an ERP were randomized after surgery. The experimental arm (RecoverMI) included accelerated discharge on postoperative day (POD) 1 with or without evidence of bowel function and a televideoconference on POD 2. The control arm was standard postoperative care. The primary endpoint was total 30‐day LOS (postoperative stay plus readmission/emergency department/observation days). Secondary endpoints included patient‐reported outcomes measured by EQ‐5D‐5L™, Brief Pain Inventory (BPI) and a satisfaction questionnaire.
Results
Thirty patients were randomized after robotic (21 patients) or laparoscopic (9) colectomy, including 14 patients in the RecoverMI arm. Median 30‐day total LOS was 28·3 (i.q.r. 23·7–43·6) h in the RecoverMI arm and 51·5 (43·8–67·0) h in the control arm (P = 0·041). There were no differences in severe adverse events or EQ‐5D‐5L™ score between the study arms. The BPI revealed low pain scores regardless of treatment arm. Satisfaction was high in both arms.
Conclusion
In patients having surgery for colorectal neoplasms, the trimodal combination of MIS, ERP and TeleRecovery can reduce 30‐day LOS while preserving patients' quality of life and satisfaction. Registration number: NCT02613728 (
https://clinicaltrials.gov).
CMG were employees of Invicro, LLC when the studies were performed. JMS is currently an employee of Biogen Inc. NJA, LK, and ROC are employees of the University of Southampton. MB is an employee of 3D Imaging, and AV was an employee of Biogen Inc. at the time that this work was performed.
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