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ERAS in Choledochal Cyst & Biliary Atresia

2026년 7월 13일 업데이트: Muhammad Zubair Shoukat

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Muhammad Zubair Shoukat, MBBS, FCPS Pediatric Surgery
  • 전화번호: 03126446646
  • 이메일: zubairshaukat@outlook.com

연구 장소

    • Punjab Province
      • Lahore, Punjab Province, 파키스탄, 54300
        • 모병
        • University of Child Health Sciences, The Children's Hospital, Lahore

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. All children diagnosed with choledochal cyst type I and IV on MRCP or CT scan, undergoing elective Roux-En-Y hepaticojejunostomy
  2. All children with provisional diagnosis of biliary atresia undergoing Roux-En-Y portoenterostomy

Exclusion Criteria:

  1. 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
  2. patients with history of Emergency surgery or external drainage of choledochal cyst
  3. Hemodynamically unstable patients after surgery
  4. Previous history of GI surgery

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른 이름들:
  • Fast-tract feeding protocol
  • Early oral feeding
활성 비교기: 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
다른 이름들:
  • Conventional Feeding Protocol
실험적: 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.
다른 이름들:
  • Fast-tract feeding protocol
  • Early oral feeding
활성 비교기: 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
다른 이름들:
  • Conventional Feeding Protocol

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Wound Infection
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Vomiting
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Sundas Zahra, MBBS, University of Child Health sciences & The Children's Hospital, Lahore

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 7월 27일

기본 완료 (추정된)

2026년 7월 1일

연구 완료 (추정된)

2026년 8월 1일

연구 등록 날짜

최초 제출

2026년 6월 13일

QC 기준을 충족하는 최초 제출

2026년 7월 13일

처음 게시됨 (실제)

2026년 7월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 13일

마지막으로 확인됨

2026년 7월 1일

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담도 폐쇄증, Kasai Portoenterostomy 상태에 대한 임상 시험

Enhanced Recovery After Surgery에 대한 임상 시험

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