A RCT Study of ERAS in Infants With Choledochal Cyst

March 14, 2023 updated by: Weibing Tang, Nanjing Children's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Children's Hospital of Nanjing Medical University
        • Contact:
          • Xiaofeng Lv, Master
          • Phone Number: +86 13770848430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ERAS group
To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period
Behavioral: Perioperative accelerated rehabilitation surgical measures
To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period
Other: placebo group
In this gruop,Children with cholangiectasia were given traditional perioperative treatment
Behavioral: Traditional treatment
To provide traditional perioperative treatment for children with cholangiectasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative length of stay
Time Frame: through study completion, an average of 1 year
To record the postoperative length of stay
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastrointestinal functional recovery
Time Frame: through study completion, an average of 1 month
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
Gastrointestinal decompression tube indwelling time
Time Frame: through study completion, an average of 1 month
To calculate the indwelling time of Gastrointestinal decompression tube after surgery
through study completion, an average of 1 month
Peritoneal drainage tube indwelling time
Time Frame: through study completion, an average of 1 month
To calculate the indwelling time of Peritoneal drainage tube
through study completion, an average of 1 month
Blood cortisol level
Time Frame: 24 hours after surgery
To test the consentration of cortisol in blood
24 hours after surgery
IL-6 level
Time Frame: 24 hours after surgery
To test the consentration of IL-6 in blood
24 hours after surgery
IL-10 level
Time Frame: 24 hours after surgery
To test the consentration of IL-10 in blood
24 hours after surgery
C-reactive protein (CRP)
Time Frame: 24 hours after surgery
To test the consentration of CRP in blood
24 hours after surgery
complication rate
Time Frame: one month after surgery
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
Hospitalization expenses
Time Frame: through study completion, an average of 1 month
the hospitalization cost of the child
through study completion, an average of 1 month
Parents satisfaction score
Time Frame: through study completion, an average of 1 month
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
30-day readmission rate
Time Frame: one month after surgery
To record the 30-day readmission rate after surgery
one month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Children's Hospital

Investigators

  • Principal Investigator: Xiaofeng Lv, Master, Children's Hospital of Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202204038-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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