A RCT Study of ERAS in Infants With Choledochal Cyst

Enhanced Recovery After Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770739
• Other study ID #: 202204038-1
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Nanjing Children's Hospital
• Contact: Xiaofeng Lv
• Phone: +86 13770848430
• Email: xflv1981[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Choledochal Cyst
• Enhanced Recovery After Surgery
• Infant ALL

Intervention

Behavioral:
• Perioperative accelerated rehabilitation surgical measures
To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period
• Traditional treatment
To provide traditional perioperative treatment for children with cholangiectasia

Locations

Country	Name	City	State
China	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative length of stay	To record the postoperative length of stay	through study completion, an average of 1 year
Secondary	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
Secondary	Gastrointestinal decompression tube indwelling time	To calculate the indwelling time of Gastrointestinal decompression tube after surgery	through study completion, an average of 1 month
Secondary	Peritoneal drainage tube indwelling time	To calculate the indwelling time of Peritoneal drainage tube	through study completion, an average of 1 month
Secondary	Blood cortisol level	To test the consentration of cortisol in blood	24 hours after surgery
Secondary	IL-6 level	To test the consentration of IL-6 in blood	24 hours after surgery
Secondary	IL-10 level	To test the consentration of IL-10 in blood	24 hours after surgery
Secondary	C-reactive protein (CRP)	To test the consentration of CRP in blood	24 hours after surgery
Secondary	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
Secondary	Hospitalization expenses	the hospitalization cost of the child	through study completion, an average of 1 month
Secondary	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
Secondary	30-day readmission rate	To record the 30-day readmission rate after surgery	one month after surgery