Interdisciplinary Scoliosis Correction Program.

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

• Registration Number: NCT05159505
• Lead Sponsor: Pomeranian Medical University Szczecin

Brief 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.

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 Timeline

• Status Verified: 2021-12
• Study Start: 2021-12-01
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-02
• Last Update Submitted: 2021-12-02
• Study First Posted: 2021-12-16
• Last Update Posted: 2021-12-16
• Primary Completion: 2022-06-30
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• patient with age < 18 years
• patient scheduled for idiopatic scoliosis surgery

Exclusion Criteria

• patient with age > 18years others type of scoliosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
type of complications	up to 4 weeks after surgery	surgery and anaesthesia complications

Secondary Outcome Measures

Name	Time	Method
Time to first verticalization	up to 6 days after surgery
Number of Analgetics consumption	up to 6 days after surgery	consumption including opioids and non-opioids drug
Time to first bowel motion	up to 6 days after surgery	Able to eat without abdominal discomfort, nausea, or vomiting
Postoperative length of hospital stay	up to 4 weeks after surgery	Postoperative length of hospital stay

Trial Locations

Locations (1)

Pomeranian Medical University; 🇵🇱 Szczecin, Poland