A RCT Study of ERAS in Infants With Choledochal Cyst

Nanjing Children's Hospital

Status: Enrolling

Conditions: Infant ALL; Cholangiectasis; Enhanced Recovery After Surgery

Treatments: Behavioral: Traditional treatment; Behavioral: Perioperative accelerated rehabilitation surgical measures

Study type: Interventional

Funder types: Other

Identifiers

NCT05770739

202204038-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 1 day to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups

ERAS group

Other group

Description:

To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period

Treatment:

Behavioral: Perioperative accelerated rehabilitation surgical measures

placebo group

Other group

Description:

In this gruop,Children with cholangiectasia were given traditional perioperative treatment

Treatment:

Behavioral: Traditional treatment