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Trial Title:
A RCT Study of ERAS in Infants With Choledochal Cyst
NCT ID:
NCT05770739
Condition:
Enhanced Recovery After Surgery
Infant ALL
Cholangiectasis
Conditions: Official terms:
Choledochal Cyst
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Perioperative accelerated rehabilitation surgical measures
Description:
To apply accelerated rehabilitation surgery to children with biliary dilatation during
perioperative period
Arm group label:
ERAS group
Intervention type:
Behavioral
Intervention name:
Traditional treatment
Description:
To provide traditional perioperative treatment for children with cholangiectasia
Arm group label:
placebo group
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:
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.
Criteria for 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
Gender:
All
Minimum age:
1 Day
Maximum age:
12 Months
Healthy volunteers:
No
Locations:
Facility:
Name:
Children's Hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210008
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaofeng Lv, Master
Phone:
+86 13770848430
Start date:
January 1, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Nanjing Children's Hospital
Agency class:
Other
Source:
Nanjing Children's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05770739
