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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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.
Wroclaw Medical University, Wrocław, Poland. Clinical Department of Paediatric Cardiosurgery, Surgery and Urology
Wroclaw, Lower Silesian Voivodeship, Poland
Medical University of Lublin, Poland. Department of Pediatric Surgery and Traumatology, University Children's Hospital
Lublin, Lublin Voivodeship, Poland
University Clinical Center, Medical University of Warsaw, Poland. Department of Pediatric Surgery, Pediatric Urology and Pediatrics
Warsaw, Masovian Voivodeship, Poland
Jagiellonian University Medical College, University Children's Hospital of Krakow, Poland. Department of Pediatric Surgery
Krakow, Małopolska, Poland
Medical University of Gdansk, Poland. Department of Surgery and Urology for Children and Adolescents
Gdansk, Pomeranian Voivodeship, Poland
Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology
Zabrze, Upper Silesia, Poland
Regional Specialist Children's Hospital in Olsztyn, Poland. Clinical Department of Pediatric Surgery and Pediatric Urology with the Vascular Anomalies Treatment Center
Olsztyn, Warmian-Masurian Voivodeship, Poland
Jan Kochanowski University of Kielce, Poland. Faculty of Medicine, Collegium Medicum; Department of Pediatric Surgery, Urology and Traumatology
Kielce, Świętokrzyskie Voivodeship, Poland
Department of Pediatric Surgery and Urology, Clinical Hospital no 2. Poland
Rzeszów, Świętokrzyskie Voivodeship, Poland
Number of participants with successful early postoperative recovery
Successful early postoperative recovery is defined as fulfillment of all of the following criteria: initiation of oral feeding according to the standardized pediatric ERAS-based protocol; tolerance of oral feeding without need for nasogastric decompression or parenteral nutrition; absence of major postoperative complications (Clavien-Dindo grade III or higher); and discharge from hospital according to standard clinical criteria.
Time frame: Within 7 days after surgery
Postoperative length of hospital stay
Duration of postoperative hospitalization measured in days from the date of surgery to the date of discharge.
Time frame: From date of surgery to date of discharge
Time to initiation of oral feeding
Time from the end of surgery to the first postoperative oral intake
Time frame: From end of surgery to first oral intake
Time to achievement of tolerance of oral feeding
Time from the end of surgery to achievement of tolerance of oral feeding, defined as continuation of postoperative oral feeding without vomiting requiring treatment interruption, nasogastric decompression, or parenteral nutrition.
Time frame: From end of surgery to achievement of tolerance of oral feeding
Proportion of protocol elements fulfilled per participant
Proportion of predefined elements of the standardized pediatric ERAS-based perioperative protocol fulfilled for each participant, assessed using the study checklist.
Time frame: During index hospitalization, from admission to discharge
Number of participants without mechanical bowel preparation before surgery
Number of participants who did not undergo mechanical bowel preparation before the index surgical procedure.
Time frame: Preoperative period, before surgery
Number of participants not requiring postoperative parenteral nutrition
Number of participants who did not require parenteral nutrition during postoperative hospitalization.
Time frame: From date of surgery to date of discharge
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