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

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).

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Procedure: The use of two attending surgeons during posterior spinal fusion

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study group consisted of 25 consecutive patients with CP and progressive neuromuscular scoliosis who underwent PSF in 2012 with the use of a two surgeon team. The control group consisted of a consecutive series of patients with CP who underwent PSF by a single surgeon from 2008-2010 at the same institution. The control group was a cohort of patients matched for age, gender, weight and Cobb angle.

Description

Inclusion Criteria:

• Cerebral palsy
• neuromuscular scoliosis requiring posterior spinal fusion (>50 degree Cobb)
• PSF from 2008-2012 at Phoenix Children's Hospital
• GMFCS IV or V

Exclusion Criteria:

• Diagnosis other than CP
• GMFCS I-III
• Previous spine deformity surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CP who underwent PSF by two attendings in 2012	Procedure: The use of two attending surgeons during posterior spinal fusion; Patients 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.
CP who underwent PSF by a single surgeon from 2008-2010

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Complications due to PFS surgery	Post-operative hospital stay (up to 12 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgical time	intraoperative
Estimated blood loss	intraoperative
Length of Stay	During hospitalization (up to 12 days)

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 9, 2015
• First Submitted That Met QC Criteria: September 10, 2015
• First Posted (Estimate): September 11, 2015

Study Record Updates

• Last Update Posted (Estimate): September 11, 2015
• Last Update Submitted That Met QC Criteria: September 10, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 11-124