Highlights
A multicenter stepped-wedge cluster-randomized trial across 18 US hospitals found that introducing a 21-element enhanced recovery protocol for children undergoing elective gastrointestinal surgery did not significantly reduce postoperative length of stay at the phase level.
Implementation was successful in one important respect: patient-level adherence increased substantially across baseline, implementation, and sustainment phases, indicating that centers were able to incorporate many protocol elements into routine care.
Clinical benefit became visible when fidelity was considered. Children who received at least 13 enhanced recovery elements had a 1.14-day shorter median postoperative stay and lower odds of complications than those with lower adherence.
The intervention also improved selected recovery metrics, including faster return to a regular diet and lower inpatient opioid exposure, while showing that order-set integration and institutional culture were moderately associated with better protocol fidelity.
Background
Enhanced recovery protocols, also termed enhanced recovery after surgery pathways, are structured perioperative care bundles designed to reduce physiologic stress, standardize best practices, and accelerate recovery. In adults, enhanced recovery has repeatedly been associated with shorter hospitalization, fewer complications, lower opioid use, and reduced costs across colorectal, hepatobiliary, gynecologic, urologic, and orthopedic surgery. Pediatric uptake, however, has been slower.
There are several reasons for this lag. Pediatric surgical populations are smaller and more heterogeneous, family-centered care adds complexity, perioperative workflows differ across children’s hospitals, and high-quality implementation research has been limited. Moreover, pediatric protocols often need adaptation for developmental stage, caregiver participation, nutrition strategies, and opioid-sparing pain control.
Elective gastrointestinal surgery in children and adolescents represents an especially relevant setting for enhanced recovery. These patients often undergo bowel resection, ostomy procedures, or related operations for inflammatory bowel disease or other chronic gastrointestinal conditions. Recovery can be delayed by ileus, pain, immobility, opioid exposure, and inconsistent postoperative feeding practices. A carefully designed pediatric enhanced recovery pathway therefore has strong biologic and clinical plausibility.
The ENRICH-US trial is notable because it did not only test whether a protocol worked. It also examined how well the protocol was implemented, using a hybrid implementation-effectiveness design. This is clinically important: failure of an enhanced recovery pathway may reflect either an ineffective intervention or inadequate delivery. The distinction matters for hospital leaders, surgeons, anesthesiologists, nurses, and quality-improvement teams deciding whether to invest in pediatric enhanced recovery programs.
Study Design
Trial framework
ENRICH-US was a prospective type 2 hybrid implementation-effectiveness trial using a stepped-wedge cluster-randomized design. Eighteen US sites participated between September 2019 and June 2024. In stepped-wedge trials, all sites eventually receive the intervention, but the timing of crossover is randomized. This design is attractive when the intervention is expected to be beneficial, when site-level implementation is required, and when investigators wish to evaluate both implementation and clinical effectiveness under real-world conditions.
Population
The trial enrolled 597 pediatric patients aged 10 to 18 years undergoing elective gastrointestinal surgery. The median age was 15 years, with an interquartile range of 13 to 17 years. Of the cohort, 274 patients, or 45.9%, were female and 323, or 54.1%, were male. Importantly, 433 patients, or 72.5%, had inflammatory bowel disease, indicating that the findings largely reflect an adolescent IBD surgical population rather than the full spectrum of pediatric GI surgery.
Intervention and implementation strategy
The intervention was a consensus-based 21-element enhanced recovery protocol. Although the abstract does not list every element individually, such protocols typically include preoperative counseling, minimization of fasting, multimodal analgesia, opioid-sparing strategies, standardized fluid management, antiemetic prophylaxis, early feeding, and early mobilization.
Implementation support was extensive. Sites were randomized into three groups and spent at least 9 months in a control phase with usual care before transitioning at 6-month intervals to an implementation phase and then a sustainment phase lasting 12 to 24 months. The implementation package included a structured toolkit based on 5 Active Implementation Frameworks, a one-year group-based Learning Collaborative curriculum, a tool repository, adherence feedback, and implementation report cards.
This is an unusually robust implementation strategy for pediatric perioperative care. The investigators also generated site-level scores based on 5AIF domains and examined whether these implementation metrics correlated with fidelity, an analytically useful feature that strengthens the translational value of the study.
Outcomes
The primary effectiveness outcome was postoperative length of stay. Secondary outcomes included inpatient opioid use, time to regular diet, complications, readmission, and patient-reported health-related quality of life. The study also measured protocol adherence at both patient and site level and explored the relationship between implementation scores and fidelity.
Key Findings
Primary outcome: no significant overall reduction in length of stay by study phase
The main headline result is that the enhanced recovery protocol did not significantly reduce postoperative length of stay when outcomes were compared across baseline, implementation, and sustainability phases. This phase-level neutral finding is important because it means that simply being in the “implementation era” of the trial was not enough to produce a measurable reduction in hospitalization duration across the entire cohort.
For clinicians, this is a cautionary result. It suggests that introducing a protocol, even with education, feedback, and collaborative support, does not automatically translate into improved patient outcomes at the population level. In perioperative quality improvement, the gap between protocol availability and protocol delivery remains highly consequential.
Secondary outcomes: selected improvements despite neutral overall trial result
Although the trial did not show significant phase-based improvements in most outcomes, two secondary recovery measures improved: time to regular diet was shorter and opioid use during hospitalization decreased. These are clinically meaningful findings. Earlier diet advancement reflects more confident postoperative management and may indicate reduced ileus or faster gastrointestinal recovery. Lower inpatient opioid exposure is particularly relevant in pediatric surgery, where opioid stewardship has become an important goal for both short-term safety and broader public health reasons.
No significant differences by study phase were seen for length of stay, most secondary outcomes, or readmission in the abstract summary. Likewise, there is no signal in the abstract suggesting a harm tradeoff such as increased readmissions accompanying earlier feeding or lower opioid use.
Fidelity mattered: higher patient-level adherence was associated with better outcomes
The most informative finding emerged from fidelity-adjusted analyses. Patients who received at least 13 of the enhanced recovery elements had significantly better outcomes than those with lower exposure. Median postoperative length of stay was reduced by 1.14 days, with a 95% confidence interval of -2.01 to -0.27 days. In practical terms, that is a substantial reduction for elective pediatric GI surgery, particularly when scaled across centers.
Higher adherence was also associated with fewer complications, with an adjusted odds ratio of 0.48 and a 95% confidence interval of 0.28 to 0.82. This suggests nearly a halving of complication odds among children who actually received a substantial proportion of the pathway. Because complication reduction is harder to achieve than process improvement, this result strongly supports the clinical value of the protocol when delivered with sufficient intensity.
These findings reframe the trial. Rather than concluding that pediatric enhanced recovery does not work, the more accurate interpretation is that implementation at the site-phase level was insufficiently uniform to produce a clear intention-to-treat effect, while patient-level receipt of the intervention was associated with meaningful benefit.
Adherence improved over time
Patient-level adherence increased significantly by study phase. The median number of protocol elements delivered was 11 during baseline, 14 during implementation, and 14 during sustainment, with P less than .001. This pattern is instructive for two reasons. First, centers did improve uptake, showing that the implementation strategy had real effect. Second, the plateau between implementation and sustainment suggests that once sites reached a certain level of integration, further gains may have been limited without additional redesign or automation.
Implementation determinants: order sets and culture were linked to fidelity
ERP integration into order sets and site culture were moderately correlated with fidelity. This is one of the study’s most actionable implementation findings. Order sets convert abstract recommendations into routine bedside actions, reducing reliance on memory and individual variation. Institutional culture likely captures team alignment, leadership support, accountability, and the willingness of surgeons, anesthesiologists, nurses, and dietitians to change established routines.
For hospitals seeking to operationalize these results, the message is straightforward: educational sessions alone are unlikely to be enough. High-fidelity enhanced recovery probably requires embedded clinical decision support, standardized perioperative workflows, multidisciplinary buy-in, and local ownership.
Clinical Interpretation
The ENRICH-US trial should be viewed as a positive implementation science study with a negative phase-level effectiveness result and a positive fidelity-adjusted effectiveness signal. That distinction is essential.
At first glance, the primary result appears disappointing. However, stepped-wedge implementation studies often dilute treatment effects because crossover timing, secular trends, local disruptions, variable uptake, and selective adherence all blur contrasts between phases. The COVID-19 era overlap between 2019 and 2024 may also have introduced operational variability, although the abstract does not provide a formal analysis of this issue.
The stronger message is that enhanced recovery works best when it is actually delivered. The observed threshold effect of at least 13 elements implies that protocol completeness matters. This is consistent with adult literature showing that enhanced recovery pathways are not single interventions but bundles whose benefits depend on cumulative fidelity. Early feeding without opioid-sparing analgesia, or mobilization without standardized fluids and antiemetic strategies, may not be enough to materially change length of stay.
The reduction in inpatient opioid use is especially relevant. Even without an overall length-of-stay benefit at the phase level, lower opioid exposure and faster return to regular diet represent worthwhile perioperative gains. They also align with family-centered recovery goals, reduced nausea and constipation, and potentially smoother transition home.
Strengths
This study has several major strengths. It was multicenter, prospective, and randomized at the cluster level. It used a hybrid implementation-effectiveness approach, which is well suited to complex perioperative interventions. It included a structured and theory-informed implementation package rather than an informal quality-improvement effort. It assessed both site-level and patient-level adherence and formally linked implementation determinants to fidelity. Finally, it evaluated sustainment rather than only early adoption.
These features make the study more relevant to health systems than many efficacy trials. Clinicians need to know not only whether an intervention can work under ideal conditions, but whether it can be integrated across diverse hospitals and maintained over time.
Limitations
The main limitation is the discrepancy between protocol implementation and protocol receipt. Because outcomes improved only when adherence was high, the trial’s neutral primary result may partly reflect incomplete or inconsistent delivery. That is scientifically informative but may frustrate those seeking a simple yes-or-no answer.
Generalizability is another consideration. More than 70% of participants had inflammatory bowel disease, and the age range was 10 to 18 years, with a median age of 15 years. The findings may therefore be most applicable to adolescents undergoing elective intestinal surgery rather than to infants, younger children, or the full range of pediatric abdominal operations.
The abstract does not provide the full list of ERP elements, detailed complication definitions, subgroup analyses, site heterogeneity data, cost outcomes, or patient-reported quality-of-life results. Without the full text, one cannot determine which components were most difficult to implement or whether certain elements drove the observed benefit more than others.
Finally, stepped-wedge designs are vulnerable to temporal confounding. Changes in staffing, case mix, perioperative practices, or broader health system pressures over nearly five years could affect outcomes independently of the intervention.
Implications for Practice and Policy
For pediatric surgeons and perioperative leaders, this trial supports continued investment in enhanced recovery, but with a shift in emphasis from protocol publication to protocol execution. Hospitals should track patient-level fidelity, not just whether a pathway exists. A center that reports having an enhanced recovery pathway may still be delivering it inconsistently.
Several implementation lessons stand out. First, embed the pathway into electronic order sets. Second, measure adherence element by element and feed results back to teams. Third, focus on multidisciplinary culture, since recovery pathways span surgery, anesthesia, nursing, pharmacy, nutrition, and rehabilitation. Fourth, identify a minimum fidelity target, because the apparent threshold effect suggests that partial implementation may blunt clinical benefit.
For policymakers and quality collaboratives, the trial highlights the value of implementation science metrics in surgical studies. Future benchmarking efforts may need to include fidelity indicators alongside clinical endpoints. If reimbursement or accreditation eventually incorporates pediatric enhanced recovery, process reliability should be part of the framework.
Future Research
Key next steps include defining which protocol elements are most strongly associated with improved outcomes, whether certain operations benefit more than others, and how to optimize pathway delivery in lower-volume settings. Additional work should also assess costs, caregiver-reported recovery, postdischarge opioid prescribing, and broader pediatric age groups.
A pragmatic next-generation trial might compare standard implementation support with a more automation-heavy strategy, such as mandatory order-set defaults, real-time adherence alerts, and local facilitation focused on low-performing elements. Another important question is whether the observed fidelity threshold of 13 elements is reproducible or whether different operations require different adherence targets.
Conclusion
The ENRICH-US stepped-wedge cluster-randomized trial provides a nuanced but clinically valuable message. A consensus-based pediatric enhanced recovery protocol for elective gastrointestinal surgery did not significantly shorten postoperative length of stay when evaluated by study phase alone, despite a comprehensive implementation strategy. However, protocol adherence improved over time, and children who actually received a higher proportion of pathway elements experienced shorter hospitalization and fewer complications. They also had faster return to a regular diet and lower inpatient opioid use.
In other words, the study does not argue against pediatric enhanced recovery. It argues for higher-fidelity pediatric enhanced recovery. For clinicians and hospital leaders, the practical lesson is that implementation quality is not secondary to effectiveness; in this context, it is a major determinant of effectiveness.
Funding and Trial Registration
ClinicalTrials.gov Identifier: NCT04060303.
Funding information was not provided in the abstract supplied here. Readers should consult the full JAMA Surgery article for complete funding and conflict-of-interest disclosures.
Reference
Raval MV, Tian Y, Schäfer W, Balbale SN, Perez MN, Ingram ME, Lehane A, Smith CJ, Sullivan GA, Reiter AJ, Hu A, Borst JM, Blake SC, Close S, Davis TL, Essner BS, Heiss KF, Huang LW, Wymore E, Paniagua-Perez D, Engelhardt KM, Graffy PM, Johnson JK, Lillehei CW, Gray BW, Goldstein SD, Short SS, Pandya SR, Taylor JA, Gayer C, Goldin AB, Boelig MM, Rialon KL, Jancelewicz T, Lipskar AM, Jafri M, Tracy ET, Harting MT, Sulkowski JP, Ham PB, Vali K, Cina RA, Schindel DT, Islam S, Teeple EA, Shah SR, Gosain A, Rothstein DH, Brockel MA, Chown J, Holl JL. Implementation and Effectiveness of an Enhanced Recovery Protocol for Children Undergoing Surgery: The ENRICH-US Stepped-Wedge Cluster-Randomized Trial. JAMA Surgery. 2026-05-13. PMID: 42126839. https://pubmed.ncbi.nlm.nih.gov/42126839/
