A RCT Study of ERAS in Infants With Choledochal Cyst
- Conditions
- CholangiectasisEnhanced Recovery After SurgeryInfant ALL
- Interventions
- Behavioral: Traditional treatmentBehavioral: Perioperative accelerated rehabilitation surgical measures
- Registration Number
- NCT05770739
- Lead Sponsor
- Nanjing Children's Hospital
- Brief Summary
Recently, with reference to the successful experience of accelerated rehabilitation surgery in the field of adult surgery, the investigators have conducted studies on ERAS in pediatric and even infant cholangiectasia surgery to discuss its feasibility and safety. The results showed that some items of ERAS could be safely applied in perioperative management of CBD, and could reduce traumatic stress and promote postoperative recovery. Therefore, the investigators assumed that the ERAS protocols could be safely applied in the treatment of CBD in children and even infants, reducing traumatic stress in children with CBD, promoting postoperative rehabilitation, reducing complications and hospitalization time, reducing hospitalization costs, and saving medical resources.
- Detailed Description
1. Optimize preoperative, intraoperative and postoperative perioperative management by learning from the successful experience of accelerated rehabilitation surgery model in other fields.
For example: necessary and sufficient preoperative education of children and guardians; short fasting before surgery; oral carbohydrate at 2h before surgery; breast feeding at 4h before surgery (formula feeding at 6h before surgery); improved intestinal preparation; irregular placement of nasogastric tube; the use of general anesthesia plus epidural or sacral block anesthesia during surgery; attention to the whole process of heat preservation; strict control of infusion volume; and selection of minimally invasive hands Methods of operation; early postoperative activity, multi-mode analgesia, etc.
2. According to the pathophysiological characteristics of infants with cholangiectasia, several aspects were studied: minimally invasive surgery；promote gastrointestinal motor function recovery；develop principles and plans for early postoperative feeding；Rational placement of abdominal drainage tube; precise choice of anesthesia method, etc.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Infants aged 0-12 months
- According to the clinical manifestations and preoperative imaging examination, the children admitted to hospital were diagnosed with choledochal cyst
- The legal guardian of the child signs the Informed Consent
- Have potentially life-threatening diseases of various organ systems
- Preoperatively associated with other diseases that interfere with the treatment process of the child
- Caroli's disease was diagnosed
- Any other condition that the investigator deems unsuitable for participation in the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo group Traditional treatment In this gruop,Children with cholangiectasia were given traditional perioperative treatment ERAS group Perioperative accelerated rehabilitation surgical measures To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period
- Primary Outcome Measures
Name Time Method postoperative length of stay through study completion, an average of 1 year To record the postoperative length of stay
- Secondary Outcome Measures
Name Time Method IL-6 level 24 hours after surgery To test the consentration of IL-6 in blood
complication rate one month after surgery to observe postoperative pulmonary infection, infection of incision, baby, abdominal cavity infection and the occurrence of complications such as anastomotic fistula, cholangitis.
gastrointestinal functional recovery through study completion, an average of 1 month To record the time of first exhaust and defecation and the time to return to full oral diet
Blood cortisol level 24 hours after surgery To test the consentration of cortisol in blood
C-reactive protein (CRP) 24 hours after surgery To test the consentration of CRP in blood
Gastrointestinal decompression tube indwelling time through study completion, an average of 1 month To calculate the indwelling time of Gastrointestinal decompression tube after surgery
Peritoneal drainage tube indwelling time through study completion, an average of 1 month To calculate the indwelling time of Peritoneal drainage tube
IL-10 level 24 hours after surgery To test the consentration of IL-10 in blood
Parents satisfaction score through study completion, an average of 1 month To investigate the "Parents satisfaction score scale" (minimum=0, maximun=100); the higher scores mean a better outcome.
30-day readmission rate one month after surgery To record the 30-day readmission rate after surgery
Hospitalization expenses through study completion, an average of 1 month the hospitalization cost of the child
Trial Locations
- Locations (1)
Children's Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China