Intestinal Diseases, Intestinal Resection
Conditions
Keywords
ERAS, Enhanced Recovery After Surgery, Pediatric surgery, Intestinal resection, Perioperative care
Brief 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.
Interventions
OTHERStandardized 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.
Sponsors
Michał Pasierbek
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Blinding is not feasible due to the nature of the ERAS perioperative protocol and surgical care.
Intervention model description
Prospective multicenter cohort study evaluating the implementation of a standardized pediatric ERAS-based protocol in children undergoing elective intestinal resection with primary anastomosis. Outcomes in the ERAS cohort will be compared with those of a historical control group treated before ERAS implementation in participating centers.
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients younger than 18 years * Patients undergoing elective intestinal resection with primary anastomosis * Patients treated in participating pediatric surgery departments * Patients managed according to the standardized pediatric ERAS-based protocol after its implementation in participating centers
Exclusion criteria
* Patients treated outside pediatric surgery departments * Patients requiring total parenteral nutrition prior to surgery * Emergency surgical procedures * Patients with Hirschsprung disease * Resection with stoma formation, or creation of a protective/diverting stoma during the index operation * Patients with incomplete clinical data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative day of discharge | From date of surgery to date of discharge during the index hospitalization | Postoperative day of discharge, defined as the number of postoperative calendar days from the index intestinal resection with primary anastomosis to hospital discharge. The day of surgery is defined as postoperative day 0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | From date of hospital admission to date of hospital discharge | Total length of hospital stay, defined as the number of calendar days from hospital admission to hospital discharge during the index hospitalization. |
| Postoperative day of initiation of oral feeding | From date of surgery to first oral intake during the index hospitalization | Postoperative day of first oral intake after the index surgery. The day of surgery is defined as postoperative day 0. |
| Postoperative day of achievement of tolerance of oral feeding | From date of surgery to achievement of tolerance of oral feeding during the index hospitalization | Postoperative day of achievement of tolerance of oral feeding, defined as continuation of oral feeding without vomiting requiring treatment interruption, nasogastric decompression, or postoperative parenteral nutrition. The day of surgery is defined as postoperative day 0. |
| Proportion of protocol elements fulfilled per participant | Perioperative period, from preoperative preparation to discharge after the index hospitalization | Proportion of predefined elements of the standardized pediatric ERAS-based perioperative protocol fulfilled for each participant, assessed using the study checklist. |
| Postoperative parenteral nutrition requirement | From date of surgery to date of discharge during the index hospitalization | Number of participants requiring postoperative parenteral nutrition during the index hospitalization. In the ERAS-based protocol, parenteral nutrition is not intended as routine postoperative support and is used only when oral or enteral feeding cannot be advanced because of delayed gastrointestinal recovery, clinically significant feeding intolerance, or postoperative complications. |
| 30-day postoperative complications | Within 30 days after surgery | Number of participants with any postoperative complication occurring within 30 days after the index surgery, including surgical, infectious, gastrointestinal, urinary, bleeding-related, or other clinically documented complications. |
| Major postoperative complications | Within 30 days after surgery | Number of participants with major postoperative complications, defined as Clavien-Dindo grade IIIa or higher, within 30 days after surgery. |
| 30-day readmission | Within 30 days after surgery | Number of participants requiring hospital readmission within 30 days after surgery. |
| 30-day unplanned reintervention or reoperation | Within 30 days after surgery | Number of participants requiring unplanned reoperation, radiological intervention, endoscopic intervention, or other surgical intervention for a postoperative complication within 30 days after surgery. |
| Surgical site infection, wound complication, or intra-abdominal abscess/collection | Within 30 days after surgery | Number of participants with superficial incisional, deep incisional, or organ/space surgical site infection, wound complication, or intra-abdominal abscess/collection within 30 days after surgery. |
| Anastomotic leak | Within 30 days after surgery | Number of participants with confirmed or clinically suspected anastomotic leak within 30 days after surgery. |
| Postoperative vomiting | From date of surgery to date of discharge during the index hospitalization | Number of participants with documented postoperative vomiting or retching during the index hospitalization. |
Countries
Poland
Contacts
CONTACTMichał J Pasierbek, M.D. Ph.D.
CONTACTEwa Bieniek, M.D.
PRINCIPAL_INVESTIGATORMichal Pasierbek, M.D. Ph.D.
Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology, Zabrze, Upper Silesia 41-800
Outcome results
None listed