Intestinal DiseasesPeERASNCT07504549
Implementation of a Pediatric ERAS-based Protocol in Intestinal Resection With Primary Anastomosis
A study testing Standardized Pediatric ERAS-Based Perioperative Protocol in people with Intestinal Diseases and Intestinal Resection, run by Michał Pasierbek at 9 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Intestinal Diseases, Intestinal Resection
- What is being tested?
- Standardized Pediatric ERAS-Based Perioperative Protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 9 sitesPoland
- Study dates
- 1 Apr 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Poland9 sites, 9 recruiting
- Recruiting
Medical University of Gdansk, Poland. Department of Surgery and Urology for Children and Adolescents
Gdansk, Pomeranian Voivodeship, 80- 803
Stefan Anzelewicz, M.D., +48 796 111 171, stefan.anzelewicz@gmail.com
Stefan Anzelewicz, M.D. Ph.D.
- Recruiting
Jan Kochanowski University of Kielce, Poland. Faculty of Medicine, Collegium Medicum; Department of Pediatric Surgery, Urology and Traumatology
Kielce, Świętokrzyskie Voivodeship, 25-317
Łukasz Władyszewski, M.D., +48 513 351 931, wladyszewski.lukasz@gmail.com
Przemysław Wolak, M.D.Ph.D.
- Recruiting
Jagiellonian University Medical College, University Children's Hospital of Krakow, Poland. Department of Pediatric Surgery
Krakow, Małopolska, 30- 663
Joanna Godlewska, M.D., +48 602 344 353, jgodlewska@usdk.pl
Joanna Godlewska, M.D.
- Recruiting
Medical University of Lublin, Poland. Department of Pediatric Surgery and Traumatology, University Children's Hospital
Lublin, Lublin Voivodeship, 20-093
Anna Golonka, M.D. Ph.D., +48 880 050 838, annagolonka007@gmail.com
Anna Golonka, M.D. Ph.D.
- Recruiting
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, 10-561
Tomasz Janowicz, M.D. Ph.D., +48 605 247 830, tojanow@gmail.com
Michał Puliński, M.D. Ph.D.
- Recruiting
Department of Pediatric Surgery and Urology, Clinical Hospital no 2. Poland
Rzeszów, Świętokrzyskie Voivodeship, 35-310
Anna Ogorzałek, M.D., +48 600 946 655, ogorzalki@poczta.fm
Anna Ogorzałek, M.D.
- Recruiting
University Clinical Center, Medical University of Warsaw, Poland. Department of Pediatric Surgery, Pediatric Urology and Pediatrics
Warsaw, Masovian Voivodeship, 02-091
Roksana Barglik, M.D. Ph.D, +48 780 050 600, roksana.barglik@gmail.com
Patrycja Sosnowska, M.D.Ph.D.
- Recruiting
Wroclaw Medical University, Wrocław, Poland. Clinical Department of Paediatric Cardiosurgery, Surgery and Urology
Wroclaw, Lower Silesian Voivodeship, 50-556
Katarzyna Rasiewicz, M.D., +48 71 736 49 00, kswiatek@usk.wroc.pl
Monika Bukowska, M.D., +48 71 736 49 00, monika.bukowska125@gmail.com
- Recruiting
Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology
Zabrze, Upper Silesia, 41-800
Michał J Pasierbek, M.D. Ph.D., +48 500 089 727, michal.pasierbek@sum.edu.pl
Ewa Bieniek, Trainee, +48 606 695 204, bankaewka@gmail.com
About this study
Official title: Implementation of a Standardized Pediatric ERAS-Based Protocol in Children Undergoing Elective Segmental Intestinal Resection With Primary Anastomosis: A Multicenter Prospective Study
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.
Read the 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
- Being tested
- Standardized Pediatric ERAS-Based Perioperative Protocol
- Keywords
- ERAS, Enhanced Recovery After Surgery, Pediatric surgery, Intestinal resection, Perioperative care
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Pediatric ERAS-Based Perioperative ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standardized Pediatric ERAS-Based Perioperative Protocol | Experimental | Children undergoing elective intestinal resection with primary anastomosis managed according to a standardized pediatric ERAS-based perioperative protocol developed for this multicenter study. Receives: Other: Standardized Pediatric ERAS-Based Perioperative Protocol |
| Conventional Perioperative Care (Historical Control) | No intervention | Patients who previously underwent elective intestinal resection with primary anastomosis before implementation of the ERAS protocol in participating centers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative day of discharge
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.
Measured: From date of surgery to date of discharge during the index hospitalization
Secondary outcomes (12)
Length of hospital stay
Total length of hospital stay, defined as the number of calendar days from hospital admission to hospital discharge during the index hospitalization.
Measured: From date of hospital admission to date of hospital discharge
Postoperative day of initiation of oral feeding
Postoperative day of first oral intake after the index surgery. The day of surgery is defined as postoperative day 0.
Measured: From date of surgery to first oral intake during the index hospitalization
Postoperative day of achievement of tolerance of oral feeding
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.
Measured: From date of surgery to achievement of tolerance of oral feeding during the index hospitalization
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.
Measured: Perioperative period, from preoperative preparation to discharge after the index hospitalization
Postoperative parenteral nutrition requirement
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.
Measured: From date of surgery to date of discharge during the index hospitalization
30-day postoperative complications
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.
Measured: Within 30 days after surgery
Major postoperative complications
Number of participants with major postoperative complications, defined as Clavien-Dindo grade IIIa or higher, within 30 days after surgery.
Measured: Within 30 days after surgery
30-day readmission
Number of participants requiring hospital readmission within 30 days after surgery.
Measured: Within 30 days after surgery
30-day unplanned reintervention or reoperation
Number of participants requiring unplanned reoperation, radiological intervention, endoscopic intervention, or other surgical intervention for a postoperative complication within 30 days after surgery.
Measured: Within 30 days after surgery
Surgical site infection, wound complication, or intra-abdominal abscess/collection
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.
Measured: Within 30 days after surgery
Anastomotic leak
Number of participants with confirmed or clinically suspected anastomotic leak within 30 days after surgery.
Measured: Within 30 days after surgery
Postoperative vomiting
Number of participants with documented postoperative vomiting or retching during the index hospitalization.
Measured: From date of surgery to date of discharge during the index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Apr 2026
- Primary completionMay 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michał Pasierbek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michał Pasierbek, Medical University of Silesia
- Investigators
- Michal Pasierbek, M.D. Ph.D., Principal investigator, Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology, Zabrze, Upper Silesia 41-800
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504549
- Sponsor's protocol ID
- ERAS_PED_RESECTION_2026
- Other IDs
- Ethics approval No
- Acronym
- PeERAS
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is a multicenter academic study involving pediatric patients, and no formal data-sharing agreement has been established among the participating centers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Standardized Pediatric ERAS-Based Protocol in Children Undergoing Elective Segmental Intestinal Resection With Primary Anastomosis: A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT07504549
- Acronym / sponsor ID
- PeERAS / ERAS_PED_RESECTION_2026
- Conditions
- Intestinal Diseases, Intestinal Resection
- Keywords
- ERAS, Enhanced Recovery After Surgery, Pediatric surgery, Intestinal resection, Perioperative care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Michał PasierbekUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standardized Pediatric ERAS-Based Perioperative Protocol | Experimental | Other: Standardized Pediatric ERAS-Based Perioperative ProtocolChildren undergoing elective intestinal resection with primary anastomosis managed according to a standardized pediatric ERAS-based perioperative protocol developed for this multicenter study. |
| Conventional Perioperative Care (Historical Control) | No intervention | –Patients who previously underwent elective intestinal resection with primary anastomosis before implementation of the ERAS protocol in participating centers. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Pediatric ERAS-Based Perioperative ProtocolStandardized 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. | Other | Standardized Pediatric ERAS-Based Perioperative Protocol |
Primary outcome
Postoperative day of discharge
Time frame: 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.
12 secondary outcomes
Length of hospital stay
Time frame: From date of hospital admission to date of hospital discharge
Postoperative day of initiation of oral feeding
Time frame: From date of surgery to first oral intake during the index hospitalization
Postoperative day of achievement of tolerance of oral feeding
Time frame: From date of surgery to achievement of tolerance of oral feeding during the index hospitalization
Proportion of protocol elements fulfilled per participant
Time frame: Perioperative period, from preoperative preparation to discharge after the index hospitalization
Postoperative parenteral nutrition requirement
Time frame: From date of surgery to date of discharge during the index hospitalization
30-day postoperative complications
Time frame: Within 30 days after surgery
Major postoperative complications
Time frame: Within 30 days after surgery
30-day readmission
Time frame: Within 30 days after surgery
30-day unplanned reintervention or reoperation
Time frame: Within 30 days after surgery
Surgical site infection, wound complication, or intra-abdominal abscess/collection
Time frame: Within 30 days after surgery
Anastomotic leak
Time frame: Within 30 days after surgery
Postoperative vomiting
Time frame: From date of surgery to date of discharge during the index hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is a multicenter academic study involving pediatric patients, and no formal data-sharing agreement has been established among the participating centers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Pasierbek, M.D. Ph.D. principal investigator
Medical University of Silesia, Katowice, Poland. Department of Children's Developmental Defects Surgery and Traumatology, Zabrze, Upper Silesia 41-800
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Pediatric ERAS-Based Perioperative Protocol in people with Intestinal Diseases and Intestinal Resection, run by Michał Pasierbek at 9 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michał J Pasierbek, M.D. Ph.D. (+48 500 089 727, michal.pasierbek@sum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative day of discharge (time frame: From date of surgery to date of discharge during the index hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.