Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05770739
Other study ID # 202204038-1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04963751 - ERAS in Pediatric & Adolescent Gynecology Preoperative Counseling N/A
Recruiting NCT04072419 - Application of Enhanced Recovery After Surgery for Congenital Esophageal Atresia During Perioperative Period
Recruiting NCT05564819 - Efficacy and Safety of Acetaminophen in Postoperative Pain Management of Infants Phase 1
Recruiting NCT05613439 - The Fast-track Centre for Hip and Knee Replacement Database
Completed NCT04543214 - Outcome of Enhanced Recovery After Surgery (ERAS) Protocols in Patients Undergoing Small Bowel Surgery
Not yet recruiting NCT05576766 - Enhanced Recovery After Surgery (ERAS) Pathway in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy N/A
Recruiting NCT05081804 - The Effect of Enhanced Recovery After Surgery (ERAS) for Cesarean Section on Neonatal Blood Glucose N/A
Completed NCT04538235 - Analgesic Non Inferiority of the Thoracic Bi-block in Comparison With Thoracic Epidural for VATS.
Not yet recruiting NCT05914090 - The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult N/A
Recruiting NCT05541640 - Intraoperative Lidocaine Infusion and Surgery-induced Release of Pro-inflammatory Cytokines After Abdominal Surgery N/A
Not yet recruiting NCT05511194 - Safety and Efficacy of ERAS Therapeutic Protocol for Complicated Appendicitis in Children N/A
Recruiting NCT05528484 - Self-reported Outcomes of Patients in ERAS Nursing N/A
Recruiting NCT04596800 - Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial Phase 3
Completed NCT04648644 - Application of ERAS Protocol in Emergency Surgery
Completed NCT02949518 - Enhanced Recovery After Spine Surgery N/A
Active, not recruiting NCT06457100 - Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery Phase 1/Phase 2
Recruiting NCT06137976 - Surgeon Perception of Gastric Decompression at Time of Gynecologic Laparoscopy N/A
Completed NCT06118593 - Why in Hospital After Wedge Resection
Active, not recruiting NCT06369194 - POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
Recruiting NCT04576533 - Patients Undergoing Laparoscopic Colorectal Surgery Walk Out From Operating Room After Surgery ( WOFOR-C1 ) N/A