Clinical Trials Directory

Trials / Completed

CompletedNCT02547090

Minimizing Complications in Scoliosis Surgery in Children With Cerebral Palsy

The Effect of Two Surgeons on Blood Loss and Operative Time in Cerebral Palsy (CP) Patients Undergoing Posterior Spinal Fusion

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Phoenix Children's Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Background: Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of complications and mortality. Complication rates have been reported as high as 45%, and infection rates typically reported at 15%. Efforts to improve efficiency by reducing operative time and blood loss could decrease these risks. The purpose of this study is to investigate the impact of utilizing two attending surgeons on blood loss, operative time, and complications in this population. Methods: This is a prospective, matched cohort analysis with a consecutive series of patients with CP who underwent PSF, with two attending surgeons, in 2012. These are matched with a control group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident, PA, or RN-FA. The groups are compared using paired Student T-tests and chi square tests (significance set a p\<0.05).

Conditions

Interventions

TypeNameDescription
PROCEDUREThe use of two attending surgeons during posterior spinal fusionPatients in the experimental group received posterior spinal fusion with two attending surgeons. Patients in the control group received posterior spinal fusion with one attending surgeon and one first assist, which could be a resident, PA, or nurse.

Timeline

Start date
2012-02-01
Primary completion
2014-05-01
Completion
2015-03-01
First posted
2015-09-11
Last updated
2015-09-11

Source: ClinicalTrials.gov record NCT02547090. Inclusion in this directory is not an endorsement.