Impact of Facilitation of Early Mobilization on Postoperative Pulmonary Outcomes After Colorectal Surgery: A Randomized Controlled Trial.

OBJECTIVE: To estimate the extent to which staff-directed facilitation of early mobilization impacts recovery of pulmonary function and 30-day postoperative pulmonary complications (PPCs) after colorectal surgery. SUMMARY BACKGROUND DATA: Early mobilization after surgery is believed to improve pulmonary function and prevent PPCs; however, adherence is low. The value of allocating resources (eg, staff time) to increase early mobilization is unknown. METHODS: This study involved the analysis of a priori secondary outcomes of a pragmatic, observer-blind, randomized trial. Consecutive patients undergoing colorectal surgery were randomized 1:1 to usual care (preoperative education) or facilitated mobilization (staff dedicated to assist transfers and walking during hospital stay). Forced vital capacity, forced expiratory volume in 1 second (FEV1), and peak cough flow were measured preoperatively and at 1, 2, 3 days and 4 weeks after surgery. PPCs were defined according to the European Perioperative Clinical Outcome Taskforce. RESULTS: Ninety-nine patients (57% male, 80% laparoscopic, median age 63, and predicted FEV1 97%) were included in the intention-to-treat analysis (usual care 49, facilitated mobilization 50). There was no between-group difference in recovery of forced vital capacity [adjusted difference in slopes 0.002 L/d (95% CI -0.01 to 0.01)], FEV1 [-0.002 L/d (-0.01 to 0.01)] or peak cough flow [-0.002 L/min/d (-0.02 to 0.02)]. Thirty-day PPCs were also not different between groups [adjusted odds ratio 0.67 (0.23-1.99)]. CONCLUSIONS: In this randomized controlled trial, staff-directed facilitation of early mobilization did not improve postoperative pulmonary function or reduce PPCs within an enhanced recovery pathway for colorectal surgery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02131844.

Construct Validity and Responsiveness of the Abdominal Surgery Impact Scale in the Context of Recovery After Colorectal Surgery.

BACKGROUND: The Abdominal Surgery Impact Scale is a patient-reported outcome measure that evaluates quality of life after abdominal surgery. Evidence supporting its measurement properties is limited. OBJECTIVE: This study aimed to contribute evidence for the construct validity and responsiveness of the Abdominal Surgery Impact Scale as a measure of recovery after colorectal surgery in the context of an enhanced recovery pathway. DESIGN: This is an observational validation study designed according to the Consensus-based Standards for the Selection of Health Measurement Instruments checklist. SETTING: This study was conducted at a university-affiliated tertiary hospital. PATIENTS: Included were 100 consecutive patients undergoing colorectal surgery (mean age, 65; 57% male). INTERVENTION: There were no interventions. MAIN OUTCOME MEASURES: Construct validity was assessed at 2 days and 2 and 4 weeks after surgery by testing the hypotheses that Abdominal Surgery Impact Scale scores were higher 1) in patients without vs with postoperative complications, 2) with higher preoperative physical status vs lower, 3) without vs with postoperative stoma, 4) in men vs women, 5) with shorter time to readiness for discharge (≤4 days) vs longer, and 6) with shorter length of stay (≤4 days) vs longer. To test responsiveness, we hypothesized that scores would be higher 1) preoperatively vs 2 days postoperatively, 2) at 2 weeks vs 2 days postoperatively, and 3) at 4 weeks vs 2 weeks postoperatively. RESULTS: The data supported 3 of the 6 hypotheses (hypotheses 1, 5, and 6) tested for construct validity at all time points. Two of the 3 hypotheses tested for responsiveness (hypotheses 1 and 2) were supported. LIMITATIONS: This study was limited by the risk of selection bias due to the use of secondary data from a randomized controlled trial. CONCLUSIONS: The Abdominal Surgery Impact Scale was responsive to the expected trajectory of recovery up to 2 weeks after surgery, but did not discriminate between all groups expected to have different recovery trajectories. There remains a need for the development of recovery-specific, patient-reported outcome measures with adequate measurement properties. See Video Abstract at http://links.lww.com/DCR/A814.

Measuring In-Hospital Recovery After Colorectal Surgery Within a Well-Established Enhanced Recovery Pathway: A Comparison Between Hospital Length of Stay and Time to Readiness for Discharge.

BACKGROUND: Hospital length of stay is often used as a measure of in-hospital recovery but may be confounded by organizational factors. Time to readiness for discharge may provide a superior index of recovery. OBJECTIVE: The purpose of this study was to contribute evidence for the construct validity of time to readiness for discharge and length of stay as measures of in-hospital recovery after colorectal surgery in the context of a well-established enhanced recovery pathway. DESIGN: This was an observational validation study designed according to the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist. SETTINGS: The study was conducted at a university-affiliated tertiary hospital. PATIENTS: A total of 100 consecutive patients undergoing elective colorectal resection (mean age = 65 y; 57% men; 81% laparoscopic) who participated in a randomized controlled trial were included. MAIN OUTCOME MEASURES: We tested a priori hypotheses that length of stay and time-to-readiness for discharge are longer in patients undergoing open surgery, with lower physical status, with severe comorbidities, with postoperative complications, undergoing rectal surgery, who are older (≥75 y), who have a new stoma, and who have inflammatory bowel disease. RESULTS: Median time-to-readiness for discharge and length of stay were both 3 days. For both measures, 6 of 8 construct validity hypotheses were supported (hypotheses 1 and 4-8). LIMITATIONS: The use of secondary data from a randomized controlled trial (risk of selection bias) was a limitation. Results may not be generalizable to institutions where patient care is not equally structured. CONCLUSIONS: This study contributes evidence to the construct validity of time-to-readiness for discharge and length of stay as measures of in-hospital recovery within enhanced recovery pathways. Our findings suggest that length of stay can be a less resource-intensive and equally construct-valid index of in-hospital recovery compared with time-to-readiness for discharge. Enhanced recovery pathways may decrease process-of-care variances that impact length of stay, allowing more timely discharge once discharge criteria are achieved. See Video Abstract at http://links.lww.com/DCR/A564.

Association of Elevated Pre-operative Hemoglobin A1c and Post-operative Complications in Non-diabetic Patients: A Systematic Review.

IMPORTANCE: Pre-operative hyperglycemia is associated with post-operative adverse outcomes in diabetic and non-diabetic patients. Current pre-operative screening includes random plasma glucose, yet plasma glycated hemoglobin (HbA1c) is a better measure of long-term glycemic control. It is not clear whether pre-operative HbA1c can identify non-diabetic patients at risk of post-operative complications. OBJECTIVE: The systematic review summarizes the evidence pertaining to the association of suboptimal pre-operative HbA1c on post-operative outcomes in adult surgical patients with no history of diabetes mellitus. EVIDENCE REVIEW: A detailed search strategy was developed by a librarian to identify all the relevant studies to date from the major online databases. FINDINGS: Six observational studies met all the eligibility criteria and were included in the review. Four studies reported a significant association between pre-operative HbA1c levels and post-operative complications in non-diabetic patients. Two studies reported increased post-operative infection rates, and two reported no difference. Of four studies assessing the length of stay, three did not observe any association with HbA1c level and only one study observed a significant impact. Only one study found higher mortality rates in patients with suboptimal HbA1c. CONCLUSIONS AND RELEVANCE: Based on the limited available evidence, suboptimal pre-operative HbA1c levels in patients with no prior history of diabetes predict post-operative complications and represent a potentially modifiable risk factor.

Biologic mesh for repair of ventral hernias in contaminated fields: long-term clinical and patient-reported outcomes.

BACKGROUND: Guidelines recommend biologic prosthetics for ventral hernia repair (VHR) in contaminated fields, yet long-term and patient-reported data are limited. We aimed to determine the long-term rate of hernia recurrence, and other clinical and patient-reported outcomes following the use of porcine small intestine submucosa (PSIS) for VHR in a contaminated field. METHODS: Consecutive patients undergoing open VHR with PSIS mesh in a contaminated field from 2004 to 2014 were prospectively evaluated for hernia recurrence and other post-operative complications. Multivariate logistic and Cox regression analyses identified predictors of hernia recurrence and surgical site infection. Patient-reported outcomes were evaluated using SF-36, Hernia-Related Quality-of-Life Survey (HerQLes) and Body Image Questionnaire instruments. RESULTS: Forty-six hernias were repaired in clean-contaminated [16 (35 %)], contaminated [11 (24 %)] and dirty [19 (41 %)] fields. Median follow-up was 47 months [interquartile range: 31-79] and all patients had greater than 12-month follow-up. Sixteen patients (35 %) were not re-examined. Incidence of surgical site events and surgical site infection were 43 % (n = 20) and 56 % (n = 25), respectively. American Society of Anesthesiologists score 3 or greater was an independent predictor of surgical site infection (odds ratio 5.34 [95 % confidence interval 1.01-41.80], p = 0.04). Hernia recurrence occurred in 61 % (n = 28) with a median time to diagnosis of 16 months [interquartile range 8-26]. After bridged repair, 16 of 18 patients (89 %) recurred, compared to 12 of 28 (43 %) when fascia was approximated (p < 0.01). Bridged repair was an independent predictor of recurrence (odds ratio 10.67 [95 % confidence interval 2.42-76.08], p < 0.01). Patients with recurrences had significantly worse scores on the SF-36 mental health component and self-perceived body image, whereas HerQLes scores were similar. CONCLUSIONS: Hernia recurrences and wound infections are high with the use of biologic PSIS mesh in contaminated surgical fields. Careful consideration is warranted using this approach.

Ensuring Early Mobilization Within an Enhanced Recovery Program for Colorectal Surgery: A Randomized Controlled Trial.

OBJECTIVE: To estimate the extent to which the addition of staff-directed facilitation of early mobilization to an Enhanced Recovery Program (ERP) impacts recovery after colorectal surgery, compared with usual care. SUMMARY BACKGROUND DATA: Early mobilization is considered an important component of ERPs but, despite guidelines recommendations, adherence remains quite low. The value of dedicating specific resources (eg, staff time) to increase early mobilization is unknown. METHODS: This randomized trial involved 99 colorectal surgery patients in an established ERP (median age 63, 57% male, 80% laparoscopic) randomized 1:1 to usual care (including preoperative education about early mobilization with postoperative daily targets) or facilitated mobilization [staff dedicated to assist transfers and walking from postoperative days (PODs) 0-3]. Primary outcome was the proportion of patients returning to preoperative functional walking capacity (6-min walk test) at 4 weeks after surgery. We also explored the association of the intervention with in-hospital mobilization, time to achieve discharge criteria, time to recover gastrointestinal function, 30-day comprehensive complication index, and patient-reported outcome measures. RESULTS: In the facilitated mobilization group, adherence to mobilization targets was greater on POD0 [OR 4.7 (95% CI 1.8-11.9)], POD1 [OR 6.5 (95% CI 2.3-18.3)], and POD2 [OR 3.7 (95% CI 1.2-11.3)]. Step count was at least 2-fold greater on POD1 [mean difference 843.3 steps (95% CI 219.5-1467.1)] and POD2 [mean difference 1099.4 steps (95% CI 282.7-1916.1)] There was no between-group difference in recovery of walking capacity at 4 weeks after surgery [OR 0.77 (95% CI 0.30-1.97)]. Other outcome measures were also not different between groups. CONCLUSIONS: In an ERP for colorectal surgery, staff-directed facilitation of early mobilization increased out-of-bed activities during hospital stay but did not improve outcomes. This study does not support the value of allocating additional resources to ensure early mobilization in ERPs. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02131844.

The effect of early mobilization protocols on postoperative outcomes following abdominal and thoracic surgery: A systematic review.

BACKGROUND: Early mobilization is considered an important element of postoperative care; however, how best to implement this intervention in clinical practice is unknown. This systematic review summarizes the evidence regarding the impact of specific early mobilization protocols on postoperative outcomes after abdominal and thoracic surgery. METHOD: The review was performed according to PRISMA guidelines. We searched 8 electronic databases to identify studies comparing patients receiving a specific protocol of early mobilization to a control group. Methodologic quality was assessed using the Downs and Black tool. RESULTS: Four studies in abdominal surgery (3 randomized controlled trials [RCTs] and 1 observational prospective study) and 4 studies in thoracic surgery (3 RCTs and 1 observational retrospective study) were identified. None of the 5 studies evaluating postoperative complications reported differences between groups. One of 4 studies evaluating duration of stay reported a significant decrease in the intervention group. One of 3 studies evaluating gastrointestinal function reported differences in favor of the intervention group. One of 4 studies evaluating performance-based outcomes reported differences in favor of the intervention group. One of 5 studies evaluating patient-reported outcomes reported differences in favor of the intervention group. Overall methodologic quality was poor. CONCLUSION: Few comparative studies have evaluated the impact of early mobilization protocols on outcomes after abdominal and thoracic surgery. The quality of these studies was poor and results were conflicting. Although bed rest is harmful, there is little available evidence to guide clinicians in effective early mobilization protocols that increase mobilization and improve outcomes.

Systematic review of the influence of enhanced recovery pathways in elective lung resection.

OBJECTIVE: Enhanced-recovery pathways aim to accelerate postoperative recovery and facilitate early hospital discharge. The aim of this systematic review was to summarize the evidence regarding the influence of this intervention in patients undergoing lung resection. METHODS: The review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement. Eight bibliographic databases (Medline, Embase, BIOSIS, CINAHL, Web of Science, Scopus, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials) were searched for studies comparing postoperative outcomes in adult patients treated within an enhanced-recovery pathway or traditional care. Risk of bias was assessed using the Cochrane Collaboration risk of bias tool. RESULTS: Six studies fulfilled our selection criteria (1 randomized and 5 nonrandomized studies). All the nonrandomized studies reported shorter length of stay in the intervention group (difference, 1.2-9.1 days), but the randomized study reported no differences. There were no differences between groups in readmissions, overall complications, and mortality rates. Two nonrandomized studies reported reduction in hospital costs in the intervention group. Risk of bias favoring enhanced recovery pathways was high. CONCLUSIONS: A small number of low-quality comparative studies have evaluated the influence of enhanced-recovery pathways in patients undergoing lung resection. Some studies suggest that this intervention may reduce length of stay and hospital costs, but they should be interpreted in light of several methodologic limitations. This review highlights the need for well-designed trials to provide conclusive evidence about the role of enhanced-recovery pathways in this patient population.

The six-minute walk test as a measure of postoperative recovery after colorectal resection: further examination of its measurement properties.

INTRODUCTION: Patients, clinicians and researchers seek an easy, reproducible and valid measure of postoperative recovery. The six-minute walk test (6MWT) is a low-cost measure of physical function, which is a relevant dimension of recovery. The aim of the present study was to contribute further evidence for the validity of the 6MWT as a measure of postoperative recovery after colorectal surgery. METHODS: This study involved a sample of 174 patients enrolled in three previous randomized controlled trials. Construct validity was assessed by testing the hypotheses that the distance walked in 6 min (6MWD) at 4 weeks after surgery is greater (1) in younger versus older patients, (2) in patients with higher preoperative physical status versus lower, (3) after laparoscopic versus open surgery, (4) in patients without postoperative complications versus with postoperative complications; and that 6MWD (5) correlates cross-sectionally with self-reported physical activity as measured with a questionnaire (CHAMPS). Statistical analysis was performed using linear regression and Spearman's correlation. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to guide the formulation of hypotheses and reporting of results. RESULTS: One hundred and fifty-one patients who completed the 6MWT at 4 weeks after surgery were included in the analysis. All hypotheses tested for construct validity were supported by the data. Older age, poorer physical status, open surgery and occurrence of postoperative complications were associated with clinically relevant reduction in 6MWD (>19 m). There was a moderate positive correlation between 6MWD and patient-reported physical activity (r = 0.46). CONCLUSIONS: This study contributes further evidence for the construct validity of the 6MWT as a measure of postoperative recovery after colorectal surgery. Results from this study support the use of the 6MWT as an outcome measure in studies evaluating interventions aimed to improve postoperative recovery.