Early Oral Feeding Versus Conventional Feeding After Surgery for Biliary Atresia and Choledochal Cyst: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Wound Infection
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Wound Infection
时间窗: 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.
Anastomotic Leak
时间窗: 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
Length of Hospital Stay
时间窗: From the date of surgery until the date of hospital discharge, assessed up to 30 days
Duration of stay measured in days
次要结局
- Vomiting(From start of feeding till 30 days post-operatively)
- Abdominal Distension(from initiation of oral feeds till 30 days post-operatively)
- Need for Re-operation(From start of oral feeds till 04 weeks post-op)
研究者
Muhammad Zubair Shoukat
Dr.
University of Child Health Sciences and Children's Hospital, Lahore