Scoliosis IdiopathicNCT05159505
Interdisciplinary Scoliosis Correction Program.
An observational study of Scoliosis Idiopathic and Scoliosis; Juvenile, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
The aim of this study is to compare the outcomes after scoliosis surgery before and after the implementation of an interdisciplinary juvenile scoliosis correction program in teenager based on ERAS (enhanced recovery after surgery) principles. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic, Scoliosis; Juvenile, Scoliosis
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2021to 30 Sep 2022
- Phase
- Observational
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Caucasian children undergoing orthopedics surgery (e.g. spine surgery for adolescent idiopathic scoliosis).
Who may be able to join
- patient with age < 18 years
- patient scheduled for idiopatic scoliosis surgery
Who cannot join
- patient with age > 18years others type of scoliosis
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Pomeranian Medical University
Szczecin, 70-204
Jowita Biernawska, MD PhD, +48501337073, lisienko@wp.pl
About this study
Official title: Strategies for the Implementation of an Interdisciplinary Juvenile Scoliosis Correction Program Based on ERAS Principles. Before-after Study.
The aim of this study is to compare the outcomes after scoliosis surgery before and after the implementation of an interdisciplinary juvenile scoliosis correction program in teenager based on ERAS (enhanced recovery after surgery) principles.
Read the detailed description
Creating an optimal protocol for interdisciplinary care in the perioperative period in terms of therapeutic management (anesthesia and surgery schedule), as well as care, rehabilitation and ensuring mental well-being determines the real impact on the reduction of the risk of complications in the perioperative period. Enhanced recovery after surgery (ERAS) protocol has been found to result in reduced lenght of stay and complications in adult patients. Data in pediatric population remains modest. In addition to ERAS principles our terapeutic team has created a special educational application for better patient preparation for surgery. The purpose of the application is to explain the general rules of conduct in the process of preparing and carrying out surgery, anesthesia, prehabilitation and physiotherapy in children undergoing orthopedics surgery (e.g. spine surgery for adolescent idiopathic scoliosis).
Hypothesis: Implementing an interdisciplinary juvenile scoliosis correction program based on ERAS principles and special educational app. will improve patient outcomes leading to a statistically significant reduction in post-operative pain and opioids demand, complication rate, length of stay without increasing readmissions and cost.
- Conditions
- Scoliosis Idiopathic, Scoliosis; Juvenile, Scoliosis, ERAS, Complication,Postoperative, Complication of Surgical Procedure
- Medical subject headings
- Scoliosis, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| "the before" group | 40 teenagers after scoliosis surgery before interdisciplinary program implementation | |
| "the after" group 1 | 40 teenagers after scoliosis surgery after ERAS program implementation | |
| "the after" group 2 | 40 teenagers after scoliosis surgery after ERAS and educational program implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
type of complications
surgery and anaesthesia complications
Measured: up to 4 weeks after surgery
Secondary outcomes (4)
Postoperative length of hospital stay
Postoperative length of hospital stay
Measured: up to 4 weeks after surgery
Number of Analgetics consumption
consumption including opioids and non-opioids drug
Measured: up to 6 days after surgery
Time to first bowel motion
Able to eat without abdominal discomfort, nausea, or vomiting
Measured: up to 6 days after surgery
Time to first verticalization
Measured: up to 6 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start1 Dec 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jowita Biernawska, Pomeranian Medical University Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159505
- Sponsor's protocol ID
- KB-0012/126/10/2021/Z
- Status last verified
- Dec 2021
- First submitted
- 2 Dec 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: nd
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies for the Implementation of an Interdisciplinary Juvenile Scoliosis Correction Program Based on ERAS Principles. Before-after Study.
- ClinicalTrials.gov ID
- NCT05159505
- Acronym / sponsor ID
- KB-0012/126/10/2021/Z
- Conditions
- Scoliosis Idiopathic, Scoliosis; Juvenile, Scoliosis, ERAS, Complication,Postoperative, Complication of Surgical Procedure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 16 Dec 2021 (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.
The aim of this study is to compare the outcomes after scoliosis surgery before and after the implementation of an interdisciplinary juvenile scoliosis correction program in teenager based on ERAS (enhanced recovery after surgery) principles.
Detailed description
Creating an optimal protocol for interdisciplinary care in the perioperative period in terms of therapeutic management (anesthesia and surgery schedule), as well as care, rehabilitation and ensuring mental well-being determines the real impact on the reduction of the risk of complications in the perioperative period. Enhanced recovery after surgery (ERAS) protocol has been found to result in reduced lenght of stay and complications in adult patients. Data in pediatric population remains modest. In addition to ERAS principles our terapeutic team has created a special educational application for better patient preparation for surgery. The purpose of the application is to explain the general rules of conduct in the process of preparing and carrying out surgery, anesthesia, prehabilitation and physiotherapy in children undergoing orthopedics surgery (e.g. spine surgery for adolescent idiopathic scoliosis).
Hypothesis: Implementing an interdisciplinary juvenile scoliosis correction program based on ERAS principles and special educational app. will improve patient outcomes leading to a statistically significant reduction in post-operative pain and opioids demand, complication rate, length of stay without increasing readmissions and cost.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| "the before" group | – | –40 teenagers after scoliosis surgery before interdisciplinary program implementation |
| "the after" group 1 | – | –40 teenagers after scoliosis surgery after ERAS program implementation |
| "the after" group 2 | – | –40 teenagers after scoliosis surgery after ERAS and educational program implementation |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Caucasian children undergoing orthopedics surgery (e.g. spine surgery for adolescent idiopathic scoliosis).
Key inclusion criteria (2 listed)
- patient with age < 18 years
- patient scheduled for idiopatic scoliosis surgery
Key exclusion criteria (1 listed)
- patient with age > 18years others type of scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
type of complications
Time frame: up to 4 weeks after surgery
surgery and anaesthesia complications
4 secondary outcomes
Postoperative length of hospital stay
Time frame: up to 4 weeks after surgery
Number of Analgetics consumption
Time frame: up to 6 days after surgery
Time to first bowel motion
Time frame: up to 6 days after surgery
Time to first verticalization
Time frame: up to 6 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: Undecided. nd
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis Idiopathic and Scoliosis; Juvenile, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 2 inclusion and 1 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 16 Dec 2021. 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 Poland. 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 Jowita Biernawska, MD PhD (501337073, lisienko@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
type of complications (time frame: up to 4 weeks after surgery). 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 16 Dec 2021.