ERAS in Choledochal Cyst & Biliary Atresia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-14
SponsorMuhammad Zubair Shoukat
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Enhanced Recovery After Surgery
Other interventionIn 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.
Post-operative care
Other interventionIn 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
Treatment groups
100 Participants
are divided into 4 treatment groupsGroup A: ERAS Feeding Protocol in Choledochal CystExperimental treatment 1 intervention
Group B: Conventional Feeding Protocol in Choledochal CystActive comparator 1 intervention
Group C: ERAS in Biliary AtresiaExperimental treatment 1 intervention
Group D: Conventional feeding protocol in Biliary AtresiaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Wound Infection
Condition characterized with presence of redness, swelling, warmth, pain or purulent discharge from surgical site classified according to CDC SSI grading.
Time frame
Within 04 weeks of surgery2
Anastomotic Leak
When surgical anastomosis fails and there is leakage proven with signs of peritonitis on clinical examination, pneumoperitoneum on radiographs
Time frame
Within hospital stay or on readmission within 1 month3
Length of Hospital Stay
Duration of stay measured in days
Time frame
From the date of surgery until the date of hospital discharge, assessed up to 30 daysSecondary outcomes
1
Vomiting
episodes of vomiting after surgery
Time frame
From start of feeding till 30 days post-operatively2
Abdominal Distension
Development of signs of abdominal distension on clinical examination leading to decision of holding feeds
Time frame
from initiation of oral feeds till 30 days post-operatively3
Need for Re-operation
Any sugical intervention required for post operative complications like wound infection or anastomotic leak or other previously unspecified reasons
Time frame
From start of oral feeds till 04 weeks post-opSponsors and contacts
Click on the lead sponsor to view all of their trials.
Muhammad Zubair Shoukat
Lead sponsor
University of Child Health Sciences and Children's Hospital, Lahore
Sponsor institution
University of Child Health Sciences and Children's Hospital, Lahore
Collaborator
Source ClinicalTrials.gov