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A RCT Study of ERAS in Infants With Choledochal Cyst

Primary Purpose

Enhanced Recovery After Surgery, Infant ALL, Cholangiectasis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Perioperative accelerated rehabilitation surgical measures
Traditional treatment
Sponsored by
Nanjing Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Enhanced Recovery After Surgery

Eligibility Criteria

1 Day - 12 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Children's Hospital of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ERAS group

placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

postoperative length of stay
To record the postoperative length of stay

Secondary Outcome Measures

gastrointestinal functional recovery
To record the time of first exhaust and defecation and the time to return to full oral diet
Gastrointestinal decompression tube indwelling time
To calculate the indwelling time of Gastrointestinal decompression tube after surgery
Peritoneal drainage tube indwelling time
To calculate the indwelling time of Peritoneal drainage tube
Blood cortisol level
To test the consentration of cortisol in blood
IL-6 level
To test the consentration of IL-6 in blood
IL-10 level
To test the consentration of IL-10 in blood
C-reactive protein (CRP)
To test the consentration of CRP in blood
complication rate
to observe postoperative pulmonary infection, infection of incision, baby, abdominal cavity infection and the occurrence of complications such as anastomotic fistula, cholangitis.
Hospitalization expenses
the hospitalization cost of the child
Parents satisfaction score
To investigate the "Parents satisfaction score scale" (minimum=0, maximun=100); the higher scores mean a better outcome.
30-day readmission rate
To record the 30-day readmission rate after surgery

Full Information

First Posted
January 30, 2023
Last Updated
March 14, 2023
Sponsor
Nanjing Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05770739
Brief Title
A RCT Study of ERAS in Infants With Choledochal Cyst
Official Title
Application of Enhanced Recovery After Surgery During the Perioperative Period in Infants With Choledochal Cyst- a Multi-center Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enhanced Recovery After Surgery, Infant ALL, Cholangiectasis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ERAS group
Arm Type
Other
Arm Description
To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period
Arm Title
placebo group
Arm Type
Other
Arm Description
In this gruop,Children with cholangiectasia were given traditional perioperative treatment
Intervention Type
Behavioral
Intervention Name(s)
Perioperative accelerated rehabilitation surgical measures
Intervention Description
To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period
Intervention Type
Behavioral
Intervention Name(s)
Traditional treatment
Intervention Description
To provide traditional perioperative treatment for children with cholangiectasia
Primary Outcome Measure Information:
Title
postoperative length of stay
Description
To record the postoperative length of stay
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
gastrointestinal functional recovery
Description
To record the time of first exhaust and defecation and the time to return to full oral diet
Time Frame
through study completion, an average of 1 month
Title
Gastrointestinal decompression tube indwelling time
Description
To calculate the indwelling time of Gastrointestinal decompression tube after surgery
Time Frame
through study completion, an average of 1 month
Title
Peritoneal drainage tube indwelling time
Description
To calculate the indwelling time of Peritoneal drainage tube
Time Frame
through study completion, an average of 1 month
Title
Blood cortisol level
Description
To test the consentration of cortisol in blood
Time Frame
24 hours after surgery
Title
IL-6 level
Description
To test the consentration of IL-6 in blood
Time Frame
24 hours after surgery
Title
IL-10 level
Description
To test the consentration of IL-10 in blood
Time Frame
24 hours after surgery
Title
C-reactive protein (CRP)
Description
To test the consentration of CRP in blood
Time Frame
24 hours after surgery
Title
complication rate
Description
to observe postoperative pulmonary infection, infection of incision, baby, abdominal cavity infection and the occurrence of complications such as anastomotic fistula, cholangitis.
Time Frame
one month after surgery
Title
Hospitalization expenses
Description
the hospitalization cost of the child
Time Frame
through study completion, an average of 1 month
Title
Parents satisfaction score
Description
To investigate the "Parents satisfaction score scale" (minimum=0, maximun=100); the higher scores mean a better outcome.
Time Frame
through study completion, an average of 1 month
Title
30-day readmission rate
Description
To record the 30-day readmission rate after surgery
Time Frame
one month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaofeng Lv
Phone
+86 13770848430
Email
xflv1981@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Lv, Master
Organizational Affiliation
Children's Hospital of Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Lv, Master
Phone
+86 13770848430

12. IPD Sharing Statement

Learn more about this trial

A RCT Study of ERAS in Infants With Choledochal Cyst

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