A RCT Study of ERAS in Infants With Choledochal Cyst

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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Application of Enhanced Recovery After Surgery During the Perioperative Period in Infants With Choledochal Cyst- a Multi-center Randomized Clinical Trial

Conditions
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Enhanced Recovery After Surgery, Infant ALL, Cholangiectasis

Intervention / Treatment
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* Behavioral: Perioperative accelerated rehabilitation surgical measures
* Behavioral: Traditional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ERAS group<br>To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period | Behavioral: Perioperative accelerated rehabilitation surgical measures<br>* To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period<br>|
| Other: placebo group<br>In this gruop,Children with cholangiectasia were given traditional perioperative treatment | Behavioral: Traditional treatment<br>* To provide traditional perioperative treatment for children with cholangiectasia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative length of stay | To record the postoperative length of stay | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastrointestinal functional recovery | To record the time of first exhaust and defecation and the time to return to full oral diet | through study completion, an average of 1 month | 
| Gastrointestinal decompression tube indwelling time | To calculate the indwelling time of Gastrointestinal decompression tube after surgery | through study completion, an average of 1 month | 
| Peritoneal drainage tube indwelling time | To calculate the indwelling time of Peritoneal drainage tube | through study completion, an average of 1 month | 
| Blood cortisol level | To test the consentration of cortisol in blood | 24 hours after surgery | 
| IL-6 level | To test the consentration of IL-6 in blood | 24 hours after surgery | 
| IL-10 level | To test the consentration of IL-10 in blood | 24 hours after surgery | 
| C-reactive protein (CRP) | To test the consentration of CRP in blood | 24 hours after surgery | 
| complication rate | to observe postoperative pulmonary infection, infection of incision, baby, abdominal cavity infection and the occurrence of complications such as anastomotic fistula, cholangitis. | one month after surgery | 
| Hospitalization expenses | the hospitalization cost of the child | through study completion, an average of 1 month | 
| Parents satisfaction score | To investigate the Parents satisfaction score scale (minimum=0, maximun=100); the higher scores mean a better outcome. | through study completion, an average of 1 month | 
| 30-day readmission rate | To record the 30-day readmission rate after surgery | one month after surgery |