NCT07504549

Implementation of a Pediatric ERAS-based Protocol in Intestinal Resection With Primary Anastomosis

Implementation of a Standardized Pediatric ERAS-Based Protocol in Children Undergoing Elective Segmental Intestinal Resection With Primary Anastomosis: A Multicenter Prospective Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Michał Pasierbek · Academic / Other
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Enhanced Recovery After Surgery (ERAS) is a multimodal perioperative care strategy designed to reduce surgical stress, decrease postoperative complications, and accelerate recovery after surgery. Although ERAS protocols are widely implemented in adult surgery, their application in pediatric surgery remains limited, and standardized perioperative guidelines for children undergoing intestinal surgery have not yet been fully established. This multicenter prospective study aims to evaluate the feasibility, safety, and clinical outcomes of implementing a standardized pediatric ERAS-based protocol in children undergoing elective intestinal resection with primary anastomosis. The study will be conducted in nine tertiary pediatric surgery centers in Poland. A total of 60 pediatric patients will be prospectively enrolled and managed according to the ERAS protocol. Outcomes in this cohort will be compared with a historical control group consisting of patients who underwent similar procedures before ERAS implementation. The primary research question is whether implementation of an ERAS protocol in pediatric intestinal surgery is safe and feasible and whether it improves postoperative recovery compared with conventional perioperative care. The study will evaluate perioperative outcomes including postoperative complications, length of hospital stay, tolerance of early oral feeding, and postoperative pain control.

Detailed description

Enhanced Recovery After Surgery (ERAS) is a multimodal perioperative care strategy designed to reduce surgical stress, minimize postoperative complications, and accelerate recovery after major surgery. The concept was initially introduced by Henrik Kehlet in the late 1990s for patients undergoing colorectal surgery. The original "fast-track surgery" program included several key elements such as multimodal analgesia, avoidance of nasogastric tubes and abdominal drains, early postoperative oral feeding, early mobilization, and early removal of urinary catheters. These measures resulted in a significant reduction in postoperative length of hospital stay without increasing postoperative complications. Subsequently, an international multidisciplinary working group led by Henrik Kehlet and Olle Ljungqvist further developed these concepts, leading to the creation of the ERAS protocol. Over the past two decades, ERAS protocols have been implemented across many surgical specialties and have consistently demonstrated improvements in postoperative outcomes, including reduced complication rates, shorter hospital stays, and faster return to normal activity. Traditional perioperative practices commonly used in surgery, such as prolonged preoperative fasting, routine mechanical bowel preparation, liberal intraoperative fluid administration, delayed postoperative feeding, routine use of nasogastric tubes and abdominal drains, and extensive use of opioid analgesia, have gradually been abandoned or significantly limited as evidence supporting ERAS principles accumulated. Instead, ERAS protocols emphasize multimodal analgesia, early postoperative oral nutrition, optimized perioperative fluid management, early mobilization, and patient-centered perioperative education. Although ERAS protocols are widely implemented and well validated in adult surgery, their application in pediatric surgery remains limited. Pediatric ERAS pathways require modification because of the physiological and developmental differences of pediatric patients. Certain elements of adult ERAS protocols, such as routine thromboprophylaxis or intensive metabolic monitoring, are not routinely applicable in children. Nevertheless, preliminary studies have demonstrated that ERAS principles are safe and feasible in pediatric surgical populations. Currently, perioperative care of children undergoing intestinal surgery in Poland varies considerably between centers, and standardized national guidelines have not yet been established. The aim of the present study is to evaluate the feasibility, safety, and clinical outcomes of a standardized pediatric ERAS-based protocol in children undergoing elective intestinal resection with primary anastomosis. Patients with Hirschsprung disease will be excluded from the study because of the distinct pathophysiology of the disease, differences in surgical management, and specific postoperative recovery patterns, which could introduce significant heterogeneity and confound the evaluation of a standardized pediatric ERAS-based protocol in intestinal resection with primary anastomosis. This multicenter study will be conducted in nine tertiary pediatric surgery centers in Poland. Due to the relatively small number of patients undergoing intestinal resection procedures in individual centers, a multicenter study design is necessary to achieve adequate statistical power. A total of 60 pediatric patients will be prospectively enrolled following implementation of the standardized pediatric ERAS-based protocol. The sample size includes an additional margin to account for potential dropouts. Outcomes in the ERAS cohort will be compared with a historical control group consisting of patients who underwent similar surgical procedures prior to the introduction of the ERAS protocol in the participating centers. All participating centers will implement the same standardized pediatric ERAS-based protocol for children undergoing elective intestinal resection. Compliance with protocol elements will be monitored using a standardized checklist completed for each patient. Key components of the standardized pediatric ERAS-based protocol include comprehensive preoperative patient and caregiver education, nutritional assessment and optimization, avoidance of prolonged preoperative fasting, preoperative carbohydrate loading, multimodal opioid-sparing analgesia including regional anesthesia techniques, optimized intraoperative fluid management, maintenance of normothermia, minimization of invasive devices such as nasogastric tubes and abdominal drains, early removal of urinary catheters, early postoperative mobilization, and early initiation of oral feeding. Postoperative pain will be assessed using age-appropriate validated scales, including the CHIPPS scale for children younger than five years, the Wong-Baker FACES Pain Rating Scale for children aged five to ten years, and the Visual Analogue Scale (VAS) for children older than ten years. The primary objective of the study is to assess the safety and feasibility of the standardized pediatric ERAS-based protocol in pediatric intestinal surgery. Secondary objectives include evaluation of postoperative recovery parameters, including length of hospital stay, postoperative complications, tolerance of early feeding, and postoperative pain control. The ultimate goal of this project is to generate high-quality multicenter evidence supporting the use of ERAS protocols in pediatric intestinal surgery and to contribute to the development of national perioperative care recommendations for children undergoing intestinal resection procedures in Poland.

Conditions

• Intestinal Diseases
• Intestinal Resection

Interventions

Type	Name	Description
OTHER	Standardized Pediatric ERAS-Based Perioperative Protocol	Standardized pediatric ERAS-based perioperative care pathway developed for this multicenter study in children undergoing elective intestinal resection with primary anastomosis. The protocol includes preoperative counseling, nutritional assessment, reduced fasting, carbohydrate loading, multimodal analgesia with regional anesthesia, optimized intraoperative fluid management, early mobilization, and early postoperative oral feeding.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-05-01
• Completion: 2028-07-01
• First posted: 2026-04-01
• Last updated: 2026-04-01

Locations

9 sites across 1 country: Poland