Clinical trial NCT05770739: A RCT Study of ERAS in Infants With Choledochal Cyst
Official title: Application of Enhanced Recovery After Surgery During the Perioperative Period in Infants With Choledochal Cyst- a Multi-center Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Enhanced Recovery After Surgery
Infant ALL
Cholangiectasis
Lead sponsor: Nanjing Children's Hospital
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: postoperative length of stay
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: gastrointestinal functional recovery
timeFrame: through study completion, an average of 1 month
measure: Gastrointestinal decompression tube indwelling time
timeFrame: through study completion, an average of 1 month
measure: Peritoneal drainage tube indwelling time
timeFrame: through study completion, an average of 1 month
measure: Blood cortisol level
timeFrame: 24 hours after surgery
measure: IL-6 level
timeFrame: 24 hours after surgery
measure: IL-10 level
timeFrame: 24 hours after surgery
measure: C-reactive protein (CRP)
timeFrame: 24 hours after surgery
measure: complication rate
timeFrame: one month after surgery
measure: Hospitalization expenses
timeFrame: through study completion, an average of 1 month
measure: Parents satisfaction score
timeFrame: through study completion, an average of 1 month
measure: 30-day readmission rate
timeFrame: one month after surgery
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Children's Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Children's Hospital of Nanjing Medical University
name: Xiaofeng Lv, Master
role: PRINCIPAL_INVESTIGATOR
References: