Pediatric DisorderEPAANCT03712657
ERAS for Pediatric Acute Appendicitis
A study testing ERAS in people with Pediatric Disorder and Complicated Appendicitis, run by Feng Jiexiong at 1 site in China.
Trial summary
This multicenter, prospective randomized controlled study is designed to applicate perioperative Enhanced recovery after surgery (ERAS) management for children with acute complicated appendicitis, the aim is to promote postoperative recovery, shorten the hospital length of stay, and reduce the incidence of… Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Pediatric Disorder, Complicated Appendicitis
- What is being tested?
- ERAS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 893 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2022to 31 Oct 2023
- 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 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ages<14; no gender limitation;
- Alvarado scores ≥7;
- preoperative radiography examination indicated complicated appendicitis;
- Patients or their legal representatives have signed "informed consent"
Who cannot join
- complicated life-threatening disease;
- perioperative exploration not appendicitis;
- Recently participated in other clinical trials within 3 months;
- Researchers found not fit to participate in this trial for any condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center Research Manual for the Perioperative Application of Enhanced Recovery After Surgery in Pediatric Acute Appendicitis
This multicenter, prospective randomized controlled study is designed to applicate perioperative Enhanced recovery after surgery (ERAS) management for children with acute complicated appendicitis, the aim is to promote postoperative recovery, shorten the hospital length of stay, and reduce the incidence of postoperative complications.
Read the detailed description
The purpose of this study is through multi-center prospective RCT research, to discuss the application of ERAS in children with acute complicated appendicitis, including its preoperative rehydration, postoperative analgesia, preoperative and postoperative antibiotics application, as well as the discharge standards and so on. The major outcome is whether it can reduce the length of stay in hospital (LOS), secondary outcomes are included the incidence of postoperative complications and postoperative readmission rate, etc.
- Conditions
- Pediatric Disorder, Complicated Appendicitis
- Being tested
- ERAS
- Keywords
- ERAS, Pediatric surgery, Emergency, Both of systolic and diastolic will be measured
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASCombination product
- preoperative pain control;
- avoiding application of ureter;
- avoiding application of gastric tube;
- avoiding application of irrigation;
- avoiding application of drainage;
- early exercising postoperatively;
- early oral feeding postoperatively;
- early discharging.
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | interventions: 1.preoperative pain control; 2.avoiding application of ureter; 3.avoiding application of gastric tube; 4.avoiding application of irrigation; 5.avoiding application of drainage; 6.early exercising postoperatively; 7.early oral feeding postoperatively; 8.early discharging. Receives: Combination Product: ERAS |
| control group | No intervention | normal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay
less hospital length of stay
Measured: through study completion, an average of 7 days
Secondary outcomes (5)
first time for postoperative feeding
earlier postoperative feeding
Measured: up to 72 hours
first time for postoperative exercising
earlier postoperative exercising
Measured: 1-2 days
rate of postoperative complication
less postoperative complication
Measured: 1 months
rate of re-operation
less rate of re-operation
Measured: 1 months
rate of re-admission
less rate of re-admission
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start10 Jan 2022
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 893 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feng Jiexiong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Jiexiong, Tongji Hospital
- Investigators
- Jiexiong Feng, MD, Principal investigator, Tongji Hospital, HUST, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712657
- Sponsor's protocol ID
- TJH
- Acronym
- EPAA
- Status last verified
- Dec 2023
- First submitted
- 7 Oct 2018
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Research Manual for the Perioperative Application of Enhanced Recovery After Surgery in Pediatric Acute Appendicitis
- ClinicalTrials.gov ID
- NCT03712657
- Acronym / sponsor ID
- EPAA / TJH
- Conditions
- Pediatric Disorder, Complicated Appendicitis
- Keywords
- ERAS, Pediatric surgery, Emergency, Both of systolic and diastolic will be measured
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 893 participants (actual)
- Lead sponsor
- Feng JiexiongUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 19 Oct 2018 (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.
This multicenter, prospective randomized controlled study is designed to applicate perioperative Enhanced recovery after surgery (ERAS) management for children with acute complicated appendicitis, the aim is to promote postoperative recovery, shorten the hospital length of stay, and reduce the incidence of postoperative complications.
Detailed description
The purpose of this study is through multi-center prospective RCT research, to discuss the application of ERAS in children with acute complicated appendicitis, including its preoperative rehydration, postoperative analgesia, preoperative and postoperative antibiotics application, as well as the discharge standards and so on. The major outcome is whether it can reduce the length of stay in hospital (LOS), secondary outcomes are included the incidence of postoperative complications and postoperative readmission rate, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Combination Product: ERASinterventions: 1.preoperative pain control; 2.avoiding application of ureter; 3.avoiding application of gastric tube; 4.avoiding application of irrigation; 5.avoiding application of drainage; 6.early exercising postoperatively; 7.early oral feeding postoperatively; 8.early discharging. |
| control group | No intervention | –normal treatment |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ages<14; no gender limitation;
- Alvarado scores ≥7;
- preoperative radiography examination indicated complicated appendicitis;
- Patients or their legal representatives have signed "informed consent"
Key exclusion criteria (4 listed)
- complicated life-threatening disease;
- perioperative exploration not appendicitis;
- Recently participated in other clinical trials within 3 months;
- Researchers found not fit to participate in this trial for any condition
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 |
|---|---|---|
| ERAS1. preoperative pain control; 2. avoiding application of ureter; 3. avoiding application of gastric tube; 4. avoiding application of irrigation; 5. avoiding application of drainage; 6. early exercising postoperatively; 7. early oral feeding postoperatively; 8. early discharging. | Combination product | ERAS group |
Primary outcome
length of stay
Time frame: through study completion, an average of 7 days
less hospital length of stay
5 secondary outcomes
first time for postoperative feeding
Time frame: up to 72 hours
first time for postoperative exercising
Time frame: 1-2 days
rate of postoperative complication
Time frame: 1 months
rate of re-operation
Time frame: 1 months
rate of re-admission
Time frame: 1 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Individual participant dataSharing planned: No. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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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.
Jiexiong Feng, MD principal investigator
Tongji Hospital, HUST, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS in people with Pediatric Disorder and Complicated Appendicitis, run by Feng Jiexiong 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 4 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: finished, as of the sponsor's last update on 8 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay (time frame: through study completion, an average of 7 days). 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 8 Dec 2023.