Comparison of Outcome of Colostomy Reversal in Pediatric Patients With Enhanced Recovery After Surgery Versus Traditional Care Protocols.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Length of Hospital Stay (Days)
研究概览
简要总结
The goal of this clinical trial is to learn whether using an Enhanced Recovery After Surgery (ERAS) protocol helps children recover faster after colostomy reversal compared with traditional care.
The main question it aims to answer is:
Does ERAS lower the number of days children need to stay in the hospital after colostomy reversal compared with traditional care?
Researchers will compare two groups:
ERAS group - Children receive shorter pre-surgery fasting, no mechanical bowel preparation, early pain control, and early feeding after surgery.
Traditional care group - Children receive the usual long bowel preparation, overnight fasting, opioid pain medicine, and a longer period without food after surgery.
Participants will:
Be randomly assigned to either the ERAS or traditional care group
Have their colostomy surgically closed by experienced pediatric surgeons
Be monitored daily until they can eat a solid meal without vomiting; this marks the end of their hospital stay
The study will enroll 60 children ages 2-13 at Children's Hospital Faisalabad, Pakistan.
Researchers will measure length of hospital stay from surgery until discharge as the main outcome.
详细描述
This single-center, prospective randomized controlled trial will compare two perioperative care strategies for pediatric colostomy reversal: the Enhanced Recovery After Surgery (ERAS) protocol and the conventional Traditional Care Protocol (TCP). The study is being conducted in the Department of Pediatric Surgery at the Children's Hospital and Institute of Child Health, Faisalabad, Pakistan.
Scientific Rationale
Colostomy reversal restores bowel continuity after temporary fecal diversion, which is frequently performed in children with anorectal malformations (ARM), Hirschsprung's disease (HD), or following severe perineal injury. Conventional postoperative care has historically included three days of mechanical bowel preparation, prolonged pre-operative fasting, routine nasogastric decompression, opioid-based analgesia, and delayed oral feeding. Evidence from both adult and pediatric literature shows that ERAS protocols-emphasizing minimal bowel preparation, shortened fasting, multimodal non-opioid analgesia, and early enteral feeding-can reduce hospital stay and enhance recovery without increasing complications. However, high-quality pediatric data, especially from South Asia, remain limited.
Study Design
The trial will enroll 60 children (ages 2-13 years) who meet inclusion criteria and have no major comorbidities or prior extensive abdominal surgery. Using a computer-generated randomization table, participants will be allocated in a 1:1 ratio to either the ERAS or TCP arm. The allocation will occur after informed consent from parents or guardians.
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
- None
入排标准
- 年龄范围
- 2 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Colostomy
- •Admitted for Reversal of colostomy
排除标准
- •Patients with endocrinal abnormalities
- •Patients with cardiac abnormalities
- •Patients with spinal abnormalities
- •Patients with bleeding abnormalities
- •Patients who have undergone previous multiple abdominal surgeries
研究组 & 干预措施
Enhanced Recovery after Surgery (ERAS)
Patients undergoing colostomy reversal managed with the Enhanced Recovery After Surgery (ERAS) protocol, which emphasizes reduced fasting, avoidance of mechanical bowel preparation, early postoperative oral feeding, and multimodal non-opioid analgesia.
干预措施: Enhanced Recovery after Surgery Protocol (Other)
Traditional Care Protocol
Patients undergoing colostomy reversal managed with the traditional perioperative care protocol, including three days of mechanical bowel preparation, overnight fasting before surgery, routine nasogastric tube placement, opioid-based postoperative pain control, and delayed resumption of oral intake.
干预措施: Traditional Care Protocol (Other)
结局指标
主要结局
Length of Hospital Stay (Days)
时间窗: From date of surgery through hospital discharge (an average of 3-14 days)
Duration of hospitalization measured from the day of surgery until discharge.
次要结局
未报告次要终点
研究者
Salman Ali
Post-Graduate Resident
Children Hospital Faisalabad