- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07709702
ERAS in Choledochal Cyst & Biliary Atresia
Early Oral Feeding Versus Conventional Feeding After Surgery for Biliary Atresia and Choledochal Cyst: A Randomized Controlled Trial
This study aims to compare two feeding approaches after surgery for biliary atresia and choledochal cyst in children.
Traditionally, children are kept without oral feeding for more than 48 hours after these operations until bowel activity returns. However, newer Enhanced Recovery After Surgery (ERAS) programs suggest that starting feeding earlier may help children recover faster.
In this study, children undergoing surgery for biliary atresia or choledochal cyst will be randomly assigned to one of two groups. One group will start oral liquids within 24 hours after surgery and gradually progress to normal feeding as tolerated (early feeding group). The other group will receive conventional care, where feeding is started after more than 48 hours once bowel activity has returned.
Researchers will compare both groups for postoperative complications such as wound infection and anastomotic leakage, as well as the duration of hospital stay. Additional observations will include vomiting, abdominal distension, need for reinsertion of a nasogastric tube, requirement for repeat surgery, and time taken to resume normal feeding.
Participation in the study will not affect the standard surgical treatment provided. All children will receive routine perioperative care and will be monitored closely throughout their hospital stay and follow-up visits. The findings of this study may help determine whether early oral feeding is a safe and effective strategy to improve recovery and reduce hospitalization after pediatric hepatobiliary surgery.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Enhanced Recovery After Surgery (ERAS) pathways are evidence-based, multidisciplinary perioperative care protocols designed to reduce surgical stress, maintain physiological function, accelerate recovery, improve patient outcomes, and reduce healthcare costs. Early enteral nutrition is a key component of ERAS programs and has been associated with improved gastrointestinal recovery, reduced postoperative morbidity, and shorter hospital stay across multiple surgical specialties.
The role of early oral feeding following pediatric hepatobiliary surgery remains insufficiently studied, particularly in low- and middle-income countries. Biliary atresia and choledochal cysts are among the most common pediatric hepatobiliary disorders requiring major reconstructive surgery. Postoperative feeding practices vary considerably, and many centers continue to delay oral intake until bowel sounds return or passage of stool occurs. However, delayed feeding may prolong recovery, increase dependence on intravenous fluids, and extend hospitalization.
This prospective randomized controlled trial will be conducted at the Department of Paediatric Surgery, University of Child Health Sciences and The Children's Hospital Lahore. The study aims to compare early oral feeding with conventional postoperative feeding in children undergoing surgery for biliary atresia and choledochal cyst.
A total of 46 eligible patients will be enrolled and randomized equally into two groups. Children aged up to 14 years undergoing elective surgery for Type I or Type IV choledochal cyst and infants up to 3 months of age undergoing surgery for biliary atresia will be considered for inclusion. Patients with preoperative malnutrition, hypoalbuminemia, emergency procedures, external cyst drainage, or those not undergoing portoenterostomy after operative cholangiography will be excluded.
All enrolled participants will receive standardized perioperative care. In the intervention group, oral clear liquids will be initiated within 24 hours after surgery and advanced progressively to semisolid and full feeds according to tolerance. In the control group, oral feeding will commence after more than 48 hours postoperatively, following clinical evidence of return of bowel function, including passage of stool or flatus.
Patients will be monitored for postoperative complications including anastomotic leakage, surgical site infection, vomiting, abdominal distension, need for nasogastric tube reinsertion, and requirement for reoperation. Discharge criteria will be standardized for both groups and include stable vital signs, adequate oral intake, satisfactory bowel function, and surgeon approval.
The primary outcomes will be postoperative hospital stay, anastomotic leakage, and surgical site infection. Secondary outcomes will include time to initiation of feeds, time to full feeding, gastrointestinal tolerance, nasogastric tube reinsertion, postoperative complications, and need for repeat surgical intervention.
Data will be analyzed using SPSS version 26. Continuous variables will be reported as mean, median, and standard deviation, while categorical variables will be presented as frequencies and percentages. Comparisons between groups will be performed using independent sample t-tests or Chi-square tests as appropriate, with statistical significance defined as a p-value ≤0.05.
This study seeks to generate local evidence regarding the safety and effectiveness of early postoperative feeding following pediatric hepatobiliary surgery. The findings may support implementation of ERAS principles in pediatric surgical practice and contribute to improved recovery, reduced hospitalization, and more efficient utilization of healthcare resources.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sundas Zahra, MBBS
- Numéro de téléphone: +923400686300
- E-mail: sundaszahra1080@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Muhammad Zubair Shoukat, MBBS, FCPS Pediatric Surgery
- Numéro de téléphone: 03126446646
- E-mail: zubairshaukat@outlook.com
Lieux d'étude
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54300
- Recrutement
- University of Child Health Sciences, The Children's Hospital, Lahore
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- All children diagnosed with choledochal cyst type I and IV on MRCP or CT scan, undergoing elective Roux-En-Y hepaticojejunostomy
- All children with provisional diagnosis of biliary atresia undergoing Roux-En-Y portoenterostomy
Exclusion Criteria:
- Patients with suspected biliary atresia not undergoing portoenterostomy after Per-op cholangiogram either due to ruling out of disease or advanced disease deemed candidates for liver transplant
- patients with history of Emergency surgery or external drainage of choledochal cyst
- Hemodynamically unstable patients after surgery
- Previous history of GI surgery
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: ERAS Feeding Protocol in Choledochal Cyst
The patients with Roux-en-Y hepaticojejunostomy for choledochal cyst will be started oral liquids within 24 hours of surgery, NG Tube will be removed before starting oral feeds
|
In ERAS feeding protocol or early oral feeding protocol, patients will be allowed oral liquids within 24 hours of surgery irrespective of confirmation of bowel functions.
Autres noms:
|
|
Comparateur actif: Conventional Feeding Protocol in Choledochal Cyst
The post operative patients of Roux-en-Y hepaticojejunostomy for choledochal cyst will be allowed oral liquids after confirmation of resumption of bowel function (Positive bowel sounds, passage of stool or flatus, clear NG aspirate)
|
In conventional feeding protocol, feeds will be resumed after surgery on confirmation of bowel functions with auscultation for bowel sounds or passage of stool or flatus, usually after 48 hours
Autres noms:
|
|
Expérimental: ERAS in Biliary Atresia
Post-op patients of Roux-en-Y portoenterostomy for biliary atresia will be allowed oral liquids within 24 hours of surgery and NG tube will be removed.
|
In ERAS feeding protocol or early oral feeding protocol, patients will be allowed oral liquids within 24 hours of surgery irrespective of confirmation of bowel functions.
Autres noms:
|
|
Comparateur actif: Conventional feeding protocol in Biliary Atresia
Post-op patients of portoenterostomy for biliary atresia will be allowed oral feeds only after confirmation of bowel functions (positive bowel sounds, passage of stool or flatus, clearing of NG aspirate)
|
In conventional feeding protocol, feeds will be resumed after surgery on confirmation of bowel functions with auscultation for bowel sounds or passage of stool or flatus, usually after 48 hours
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Wound Infection
Délai: Within 04 weeks of surgery
|
Condition characterized with presence of redness, swelling, warmth, pain or purulent discharge from surgical site classified according to CDC SSI grading.
|
Within 04 weeks of surgery
|
|
Anastomotic Leak
Délai: Within hospital stay or on readmission within 1 month
|
When surgical anastomosis fails and there is leakage proven with signs of peritonitis on clinical examination, pneumoperitoneum on radiographs
|
Within hospital stay or on readmission within 1 month
|
|
Length of Hospital Stay
Délai: From the date of surgery until the date of hospital discharge, assessed up to 30 days
|
Duration of stay measured in days
|
From the date of surgery until the date of hospital discharge, assessed up to 30 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Vomiting
Délai: From start of feeding till 30 days post-operatively
|
episodes of vomiting after surgery
|
From start of feeding till 30 days post-operatively
|
|
Abdominal Distension
Délai: from initiation of oral feeds till 30 days post-operatively
|
Development of signs of abdominal distension on clinical examination leading to decision of holding feeds
|
from initiation of oral feeds till 30 days post-operatively
|
|
Need for Re-operation
Délai: From start of oral feeds till 04 weeks post-op
|
Any sugical intervention required for post operative complications like wound infection or anastomotic leak or other previously unspecified reasons
|
From start of oral feeds till 04 weeks post-op
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sundas Zahra, MBBS, University of Child Health sciences & The Children's Hospital, Lahore
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs
- Maladies du système digestif
- Maladies des voies biliaires
- Anomalies congénitales
- Kystes
- Maladies des voies biliaires
- Anomalies du système digestif
- Maladies et anomalies congénitales, héréditaires et néonatales
- Atrésie biliaire
- Kyste du cholédoque
- Procédures chirurgicales, opératoires
- Soins périopératoires
- Récupération améliorée après la chirurgie
Autres numéros d'identification d'étude
- 1139/CH-UCHS
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .