Interdisciplinary Scoliosis Correction Program.

Scoliosis Clinical Trial

Official title:

Strategies for the Implementation of an Interdisciplinary Juvenile Scoliosis Correction Program Based on ERAS Principles. Before-after Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05159505
• Other study ID #: KB-0012/126/10/2021/Z
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: December 2021
• Source: Pomeranian Medical University Szczecin
• Contact: Jowita Biernawska, MD PhD
• Phone: 501337073
• Email: lisienko[@]wp.pl
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• patient with age < 18 years

• patient scheduled for idiopatic scoliosis surgery

Exclusion Criteria:

• patient with age > 18years others type of scoliosis

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• Complication,Postoperative
• ERAS
• Postoperative Complications
• Scoliosis
• Scoliosis Idiopathic
• Scoliosis; Juvenile

Locations

Country	Name	City	State
Poland	Pomeranian Medical University	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	type of complications	surgery and anaesthesia complications	up to 4 weeks after surgery
Secondary	Postoperative length of hospital stay	Postoperative length of hospital stay	up to 4 weeks after surgery
Secondary	Number of Analgetics consumption	consumption including opioids and non-opioids drug	up to 6 days after surgery
Secondary	Time to first bowel motion	Able to eat without abdominal discomfort, nausea, or vomiting	up to 6 days after surgery
Secondary	Time to first verticalization		up to 6 days after surgery