A RCT Study of ERAS in Infants With Choledochal Cyst

NCT05770739 | Unknown

• 1 other identifier: 202204038-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Enhanced Recovery After Surgery; Infant ALL; Cholangiectasis

Outcome Measures

Primary Outcomes (1)

• postoperative length of stay

  To record the postoperative length of stay

  through study completion, an average of 1 year

Secondary Outcomes (11)

• gastrointestinal functional recovery

  through study completion, an average of 1 month

• Gastrointestinal decompression tube indwelling time

  through study completion, an average of 1 month

• Peritoneal drainage tube indwelling time

  through study completion, an average of 1 month

• Blood cortisol level

  24 hours after surgery

• IL-6 level

  24 hours after surgery

Study Arms (2)

ERAS group

OTHER

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

Behavioral: Perioperative accelerated rehabilitation surgical measures

placebo group

OTHER

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

Behavioral: Traditional treatment

Interventions

Perioperative accelerated rehabilitation surgical measures BEHAVIORAL

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

ERAS group

Traditional treatment BEHAVIORAL

To provide traditional perioperative treatment for children with cholangiectasia

placebo group

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Children's Hospital: lead

Study Sites (1)

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210008, China

RECRUITING

Study Officials

• Xiaofeng Lv, Master

  Children's Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofeng Lv

CONTACT

+86 13770848430; xflv1981@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 15, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-02

Locations

CN (1)