NCT05770739

A RCT Study of ERAS in Infants With Choledochal Cyst

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Nanjing Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Day – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Enhanced Recovery After Surgery
• Infant ALL
• Cholangiectasis

Interventions

Type	Name	Description
BEHAVIORAL	Perioperative accelerated rehabilitation surgical measures	To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period
BEHAVIORAL	Traditional treatment	To provide traditional perioperative treatment for children with cholangiectasia

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2023-03-15
• Last updated: 2023-03-15

Locations

1 site across 1 country: China