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Accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI): a study protocol for a novel randomised controlled trial.

ABSTRACT: Definitive treatment of localised colorectal cancer involves surgical resection of the primary tumour. Short-stay colectomies (eg, 23-hours) would have important implications for optimising the efficiency of inpatient care with reduced resource utilisation while improving the overall recovery experience with earlier return to normalcy. It could permit surgical treatment of colorectal cancer in a wider variety of settings, including hospital-based ambulatory surgery environments. While a few studies have shown that discharge within the first 24 hours after minimally invasive colectomy is possible, the safety, feasibility and patient acceptability of a protocol for short-stay colectomy for colorectal cancer have not previously been evaluated in a prospective randomised study. Moreover, given the potential for some patients to experience a delay in recovery of bowel function after colectomy, close outpatient monitoring may be necessary to ensure safe implementation.In order to address this gap, we propose a prospective randomised trial of accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI) that leverages the combination of minimally invasive surgery with enhanced recovery protocols and early coordinated outpatient remote televideo conferencing technology (TeleRecovery) to improve postoperative patien-provider communication, enhance postoperative treatment navigation and optimise postdischarge care. We hypothesise that RecoverMI can be safely incorporated into multidisciplinary practice to improve patient outcomes and reduce the overall 30-day duration of hospitalisation while preserving the quality of the patient experience. ETHICS AND DISSEMINATION: RecoverMI has received institutional review board approval and funding from the American Society of Colorectal Surgeons (ASCRS; LPG103). Results from RecoverMI will be published in a peer-reviewed publication and be used to inform a multisite trial.NCT02613728; Pre-results.

SUBMITTER: Price BA

PROVIDER: S-EPMC5642654 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Accelerated enhanced <i>Recover</i>y following <i>M</i>inimally <i>I</i>nvasive colorectal cancer surgery (<i>RecoverMI</i>): a study protocol for a novel randomised controlled trial.

Price Brandee A BA Bednarski Brian K BK You Y Nancy YN Manandhar Meryna M Dean E Michelle EM Alawadi Zeinab M ZM Bryce Speer B B Gottumukkala Vijaya V Weldon Marla M Massey Robert L RL Wang Xuemei X Qiao Wei W Chang George J GJ

BMJ open 20170720 7

<h4>Introduction</h4>Definitive treatment of localised colorectal cancer involves surgical resection of the primary tumour. Short-stay colectomies (eg, 23-hours) would have important implications for optimising the efficiency of inpatient care with reduced resource utilisation while improving the overall recovery experience with earlier return to normalcy. It could permit surgical treatment of colorectal cancer in a wider variety of settings, including hospital-based ambulatory surgery environme ...[more]

PMID: 28729319

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Project description:Objectives: Although previous studies have shown the feasibility of non-intubated techniques, it is unknown whether avoiding urinary catheters can enhance recovery. This study aimed to determine whether the tubeless urinary catheter protocol is feasible and beneficial for minimally invasive lung surgery. Methods: Patients were randomized to the control group, completely tubeless group, and partially tubeless group. A propensity score-matched (PSM) analysis was performed to balance the non-random baseline characteristics. Complications and postoperative recovery were compared. Regression analysis was performed to identify the independent predictors of complications. A nomogram for predicting the risk of non-automatic micturition was constructed and internally validated. Results: One hundred fifty-nine patients were enrolled. The incidence rates of urinary irritation and urinary tract infection (UTI) were significantly lower in the tubeless groups (74.4 vs. 39.5%, p < 0.001; 28.2 vs. 8.6%, p = 0.001, respectively). The tubeless group had a higher proportion of 0-degree discomfort (81.5 vs. 30.8%, p = 0.001) and shorter duration of postoperative hospital stay than the control group (4.59 vs. 5.53 days, p < 0.001). No difference was observed in terms of urination retention and urinary incontinence between the tubeless group and the control group. After PSM, the advantages of the tubeless group still existed, and comparing to the partially tubeless group, the completely tubeless group was of even less UTI and more 0-degree discomfort (18.5 vs. 0.0%, p = 0.019; 96.3 vs. 59.3%, p = 0.002). The tubeless protocol was the only independent protective factor of urinary complications. A nomogram was constructed and showed good predictive ability. Conclusions: The tubeless catheterization protocol led to fewer complications, better compliance, and shorter hospital length of stay. The advantages were more significant with the completely tubeless protocol. The utility of our nomogram can assist clinicians in avoiding risks in performing the tubeless protocol.

Project description:Importance:Enhanced Recovery After Surgery (ERAS) care has been reported to be associated with improvements in outcomes after colorectal surgery compared with traditional care. Objective:To determine the association between ERAS protocols and outcomes in patients undergoing elective colorectal surgery. Design, Setting, and Participants:The Postoperative Outcomes Within Enhanced Recovery After Surgery Protocol (POWER) Study is a multicenter, prospective cohort study of 2084 consecutive adults scheduled for elective colorectal surgery who received or did not receive care in a self-declared ERAS center. Patients were recruited from 80 Spanish centers between September 15 and December 15, 2017. All patients included in this analysis had 1 month of follow-up. Exposures:Colorectal surgery and perioperative management were the exposures. Twenty-two individual ERAS items were assessed in all patients, regardless of whether they were included in an established ERAS protocol. Main Outcomes and Measures:The primary study outcome was moderate to severe postoperative complications within 30 days after surgery. Secondary outcomes included ERAS adherence, mortality, readmissions, reoperation rates, and hospital length of stay. Results:Between September 15 and December 15, 2017, 2084 patients were included in the study. Of these, 1286 individuals (61.7%) were men; mean age was 68 years (interquartile range [IQR], 59-77). A total of 879 patients (42.2%) presented with postoperative complications and 566 patients (27.2%) developed moderate to severe complications. The number of patients with moderate or severe complications was lower in the ERAS group (25.2% vs 30.3%; odds ratio [OR], 0.77; 95% CI, 0.63-0.94; P?=?.01). The overall rate of adherence to the ERAS protocol was 63.6% (IQR, 54.5%-77.3%), and the rate for patients from hospitals self-declared as ERAS was 72.7% (IQR, 59.1%-81.8%) vs non-ERAS institutions, which was 59.1% (IQR, 50.0%-63.6%; P?<?.001). Adherence quartiles among patients receiving the highest and lowest ERAS components showed that the patients with the highest adherence rates had fewer moderate to severe complications (OR, 0.34; 95% CI, 0.25-0.46; P?<?.001), overall complications (OR, 0.33; 95% CI, 0.26-0.43; P?<?.001), and mortality (OR, 0.27; 95% CI, 0.07-0.97; P?=?.06) compared with those who had the lowest adherence rates. Conclusions and Relevance:An increase in ERAS adherence appears to be associated with a decrease in postoperative complications.

Dataset Information

Accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI): a study protocol for a novel randomised controlled trial.

Publications

Accelerated enhanced <i>Recover</i>y following <i>M</i>inimally <i>I</i>nvasive colorectal cancer surgery (<i>RecoverMI</i>): a study protocol for a novel randomised controlled trial.

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