Enhanced Recovery After SurgeryNCT05770739
A RCT Study of ERAS in Infants With Choledochal Cyst
A study testing Perioperative accelerated rehabilitation surgical measures and Traditional treatment in people with Enhanced Recovery After Surgery and Infant ALL, run by Nanjing Children's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Enhanced Recovery After Surgery, Infant ALL, Cholangiectasis
- What is being tested?
- Perioperative accelerated rehabilitation surgical measures and Traditional treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210008
Xiaofeng Lv, Master, +86 13770848430
About this study
Official title: 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.
Read the 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.
- Conditions
- Enhanced Recovery After Surgery, Infant ALL, Cholangiectasis
- Being tested
- Perioperative accelerated rehabilitation surgical measures, Traditional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative accelerated rehabilitation surgical measuresBehavioural
To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period
Traditional treatmentBehavioural
To provide traditional perioperative treatment for children with cholangiectasia
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Other | To apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period Receives: Behavioral: Perioperative accelerated rehabilitation surgical measures |
| placebo group | Other | In this gruop,Children with cholangiectasia were given traditional perioperative treatment Receives: Behavioral: Traditional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative length of stay
To record the postoperative length of stay
Measured: through study completion, an average of 1 year
Secondary outcomes (11)
gastrointestinal functional recovery
To record the time of first exhaust and defecation and the time to return to full oral diet
Measured: through study completion, an average of 1 month
Gastrointestinal decompression tube indwelling time
To calculate the indwelling time of Gastrointestinal decompression tube after surgery
Measured: through study completion, an average of 1 month
Peritoneal drainage tube indwelling time
To calculate the indwelling time of Peritoneal drainage tube
Measured: through study completion, an average of 1 month
Blood cortisol level
To test the consentration of cortisol in blood
Measured: 24 hours after surgery
IL-6 level
To test the consentration of IL-6 in blood
Measured: 24 hours after surgery
IL-10 level
To test the consentration of IL-10 in blood
Measured: 24 hours after surgery
C-reactive protein (CRP)
To test the consentration of CRP in blood
Measured: 24 hours after surgery
complication rate
to observe postoperative pulmonary infection, infection of incision, baby, abdominal cavity infection and the occurrence of complications such as anastomotic fistula, cholangitis.
Measured: one month after surgery
Hospitalization expenses
the hospitalization cost of the child
Measured: through study completion, an average of 1 month
Parents satisfaction score
To investigate the "Parents satisfaction score scale" (minimum=0, maximun=100); the higher scores mean a better outcome.
Measured: through study completion, an average of 1 month
30-day readmission rate
To record the 30-day readmission rate after surgery
Measured: one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weibing Tang, Nanjing Children's Hospital
- Investigators
- Xiaofeng Lv, Master, Principal investigator, Children's Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770739
- Sponsor's protocol ID
- 202204038-1
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Enhanced Recovery After Surgery During the Perioperative Period in Infants With Choledochal Cyst- a Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05770739
- Acronym / sponsor ID
- 202204038-1
- Conditions
- Enhanced Recovery After Surgery, Infant ALL, Cholangiectasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nanjing Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Other | Behavioral: Perioperative accelerated rehabilitation surgical measuresTo apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period |
| placebo group | Other | Behavioral: Traditional treatmentIn this gruop,Children with cholangiectasia were given traditional perioperative treatment |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative accelerated rehabilitation surgical measuresTo apply accelerated rehabilitation surgery to children with biliary dilatation during perioperative period | Behavioural | ERAS group |
| Traditional treatmentTo provide traditional perioperative treatment for children with cholangiectasia | Behavioural | placebo group |
Primary outcome
postoperative length of stay
Time frame: through study completion, an average of 1 year
To record the postoperative length of stay
11 secondary outcomes
gastrointestinal functional recovery
Time frame: through study completion, an average of 1 month
Gastrointestinal decompression tube indwelling time
Time frame: through study completion, an average of 1 month
Peritoneal drainage tube indwelling time
Time frame: through study completion, an average of 1 month
Blood cortisol level
Time frame: 24 hours after surgery
IL-6 level
Time frame: 24 hours after surgery
IL-10 level
Time frame: 24 hours after surgery
C-reactive protein (CRP)
Time frame: 24 hours after surgery
complication rate
Time frame: one month after surgery
Hospitalization expenses
Time frame: through study completion, an average of 1 month
Parents satisfaction score
Time frame: through study completion, an average of 1 month
30-day readmission rate
Time frame: one month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaofeng Lv, Master principal investigator
Children's Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative accelerated rehabilitation surgical measures and Traditional treatment in people with Enhanced Recovery After Surgery and Infant ALL, run by Nanjing Children's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaofeng Lv (+86 13770848430, xflv1981@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative length of stay (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.