Patient-Level Adherence Drives Enhanced Recovery Benefits in Pediatric GI Surgery

Optimizing Recovery for Children After Gastrointestinal Surgery

Enhanced recovery protocols (ERPs) have become a standard of care in adult surgery, integrating multimodal strategies to minimize physiological stress and accelerate recovery. These protocols consistently reduce hospital stays, complication rates, and opioid use in procedures like oesophagectomy [1, 2], gastrectomy [3, 2], and other major abdominal surgeries [4, 5]. Research continues to refine specific elements, such as early oral feeding [6] and pain management strategies [7]. Despite this well-established success in adults, the adoption and effectiveness of similar protocols for pediatric surgical patients have been less certain [8]. A recent multi-center trial now provides a detailed assessment of a structured ERP designed for children and adolescents undergoing elective gastrointestinal surgery.

Study Design and Implementation Strategies

This study aimed to evaluate both the clinical impact and the real-world implementation of a consensus-based enhanced recovery protocol for pediatric patients undergoing elective gastrointestinal surgery. The investigators used a prospective type 2 hybrid implementation-effectiveness design, a methodology that simultaneously assesses a clinical intervention and the strategies used to integrate it into practice. The trial followed a stepped-wedge, cluster-randomized structure, where participating sites serve as their own controls, transitioning from usual care to the intervention in a staggered, randomized sequence. This design is particularly robust for evaluating how new protocols perform in varied clinical environments. The study enrolled patients aged 10 to 18 years across 18 US sites between September 2019 and June 2024.

Measuring Outcomes and Adherence

The trial's primary effectiveness outcome was postoperative length of stay (LOS), a key indicator of patient recovery and healthcare resource use. Secondary outcomes provided a broader clinical picture, including opioid consumption, time to resumption of a regular diet, postoperative complications, hospital readmission rates, and patient-reported health-related quality of life. These metrics were compared across three distinct periods for each site: a baseline phase with usual care, an implementation phase where the ERP was introduced, and a sustainability phase to assess long-term adoption. To measure implementation success, the researchers tracked adherence to the protocol's elements at both the patient and site level. They also developed site-level scores based on the 5 Active Implementation Frameworks (5AIFs), a set of conceptual domains that gauge an organization's capacity for adopting new practices. A key goal was to determine if higher implementation scores correlated with greater fidelity to the protocol, linking organizational readiness to clinical practice.

Patient Demographics and Initial Findings

The trial included 597 pediatric patients, with a median age of 15 years (interquartile range [IQR], 13-17). The cohort consisted of 274 (45.9%) female and 323 (54.1%) male patients. Notably, 433 patients (72.5%) had a diagnosis of inflammatory bowel disease, making the results highly relevant to this population. When the investigators compared outcomes across the study phases (baseline, implementation, and sustainability), they found no statistically significant difference in the primary outcome of postoperative LOS. Most secondary outcomes also remained unchanged. However, the introduction of the ERP was associated with two specific clinical improvements: patients experienced a shorter time to resuming a regular diet and required decreased opioid use during their hospitalization. This initial analysis suggested that while a site-wide ERP rollout did not shorten hospital stays on its own, it did confer tangible benefits in recovery and pain management.

The Critical Role of Patient-Level Adherence

A more granular analysis of the data revealed that the protocol's effectiveness was contingent on how consistently it was applied to individual patients. While site-level implementation did not reduce LOS, high patient-level fidelity to the ERP was associated with significantly shorter hospital stays and fewer complications. Specifically, patients who received at least 13 of the 21 ERP elements had a median LOS that was shorter by 1.14 days (95% CI, -2.01 to -0.27). This demonstrates that the protocol's benefits are realized only when a critical threshold of its components is delivered. Furthermore, high adherence was linked to a substantial improvement in safety; these patients had a nearly 50% reduction in the odds of complications, with an adjusted odds ratio of 0.48 (95% CI, 0.28-0.82). Adherence itself improved significantly throughout the trial, with the median number of ERP elements delivered per patient increasing from 11 at baseline to 14 during the implementation and sustainability phases (P < .001). The study also found that successful integration of the ERP into electronic order sets and a supportive site culture were moderately correlated with this improved fidelity, pointing to systemic factors that drive consistent application.

Clinical Implications and Future Directions

This stepped-wedge cluster-randomized trial (ClinicalTrials.gov Identifier: NCT04060303) provides a nuanced but clear message for clinicians managing pediatric gastrointestinal surgery patients. The simple act of launching an ERP at an institutional level is not sufficient to significantly reduce postoperative length of stay. The protocol's success hinges on consistent, high-fidelity application at the individual patient level. The data show that when at least 13 of the 21 protocol elements are delivered, the clinical benefits are substantial: a reduction in median LOS of 1.14 days and a nearly 50% lower odds of complications (adjusted OR, 0.48). For practicing physicians, this underscores that ERPs are not a passive checklist but an active, dose-dependent intervention. Future quality improvement efforts should therefore shift focus from mere site-level adoption to developing systems, such as integrated order sets and supportive team cultures, that ensure every patient receives the intended components of care.

References

1. Kennelly P, Davey MG, Griniouk D, Calpin G, Donlon N. Evaluating the impact of enhanced recovery after surgery protocols following oesophagectomy: a systematic review and meta-analysis of randomised clinical trials. Diseases of the esophagus. 2025. doi:10.1093/dote/doae118

2. Osilli D, Loon MM, Ibrahim FE, Brar Y. Enhanced Recovery After Surgery in Oesophagogastric Procedures: A Systematic Review of Clinical Outcomes and Postoperative Recovery. Cureus. 2025. doi:10.7759/cureus.99546

3. Liu W, He L, Yin C, Gong G. Enhanced recovery after gastrectomy: updated Meta-analysis of 27 randomized trials (2018–2025). BMC Surgery. 2025. doi:10.1186/s12893-025-03399-2

4. Wu C, Deng Z, Zhu Y, et al. Transcutaneous electrical acupoint stimulation accelerates gastrointestinal function recovery after abdominal surgery: a systemic review and meta-analysis of randomized controlled trials. International Journal of Surgery. 2025. doi:10.1097/JS9.0000000000002946

5. Feng D, Liu S, Lu Y, Wei W, Han P. Clinical efficacy and safety of enhanced recovery after surgery for patients treated with radical cystectomy and ileal urinary diversion: a systematic review and meta-analysis of randomized controlled trials. Translational Andrology and Urology. 2020. doi:10.21037/tau-19-941

6. Paudel N, Jha A, Basharat A, et al. Early Versus Delayed Oral Feeding After Esophagectomy for Esophageal Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials Assessing Safety, Clinical Recovery, and Quality of Life Outcomes.. Journal of Gastrointestinal Surgery. 2026. doi:10.1016/j.gassur.2026.102322

7. Dowell D, Ragan K, Jones CM, Baldwin G, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain—United States, 2022. MMWR Recommendations and Reports. 2022. doi:10.15585/mmwr.rr7103a1

8. Raval MV, Wymore E, Ingram ME, Tian Y, Johnson JK, Holl JL. Assessing effectiveness and implementation of a perioperative enhanced recovery protocol for children undergoing surgery: study protocol for a prospective, stepped-wedge, cluster, randomized, controlled clinical trial.. Trials. 2020. doi:10.1186/s13063-020-04851-9