Application of Enhanced Recovery After Surgery During the Perioperative Period in Infants With Choledochal Cyst- a Multi-center Randomized Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Enhanced Recovery After Surgery
- Sponsor
- Nanjing Children's Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- postoperative length of stay
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Weibing Tang
professor
Nanjing Children's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
postoperative length of stay
Time Frame: through study completion, an average of 1 year
To record the postoperative length of stay
Secondary Outcomes
- IL-6 level(24 hours after surgery)
- gastrointestinal functional recovery(through study completion, an average of 1 month)
- Blood cortisol level(24 hours after surgery)
- C-reactive protein (CRP)(24 hours after surgery)
- complication rate(one month after surgery)
- Gastrointestinal decompression tube indwelling time(through study completion, an average of 1 month)
- Peritoneal drainage tube indwelling time(through study completion, an average of 1 month)
- IL-10 level(24 hours after surgery)
- Parents satisfaction score(through study completion, an average of 1 month)
- 30-day readmission rate(one month after surgery)
- Hospitalization expenses(through study completion, an average of 1 month)