A RCT Study of ERAS in Infants With Choledochal Cyst

NCT ID: NCT05770739

Last Updated: 2023-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Enhanced Recovery After Surgery Infant ALL Cholangiectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ERAS group

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

Group Type OTHER

Perioperative accelerated rehabilitation surgical measures

Intervention Type BEHAVIORAL

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

placebo group

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

Group Type OTHER

Traditional treatment

Intervention Type BEHAVIORAL

To provide traditional perioperative treatment for children with cholangiectasia

Interventions

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Perioperative accelerated rehabilitation surgical measures

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

Intervention Type BEHAVIORAL

Traditional treatment

To provide traditional perioperative treatment for children with cholangiectasia

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weibing Tang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaofeng Lv, Master

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Nanjing Medical University

Locations

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Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaofeng Lv

Role: CONTACT

+86 13770848430

Facility Contacts

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Xiaofeng Lv, Master

Role: primary

+86 13770848430

Other Identifiers

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202204038-1

Identifier Type: -

Identifier Source: org_study_id

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