NCT05097066

Brief Summary

Neurosurgical practice has seen many important changes over several decades with advances in treatments and the types of patients treated. Neurosurgical procedures have evolved, and as outcomes have improved the number of patients being treated has increased. There are no recent evaluations of national neurosurgical practice in the United Kingdom (UK), with the last prospective cohort studies being Safe Neurosurgery 1993 and Safe Neurosurgery 2000. More recent studies of neurosurgical services have been based on data from single institutions or surgeons and these may not give a representative picture of practice nationally. Recent national quality improvement programmes for neurosurgery in England (such as the National Neurosurgical Audit Programme (NNAP) and Cranial Neurosurgery and Spinal Surgery Getting It Right First Time (GIRFT) Programmes) have focused on using national hospital administrative datasets. To be effective, quality improvement initiatives require robust outcome measures and quality (process) indicators. Currently, there is a lack of validated quality indicators for neurosurgery, with practice often being described using generic measures such as readmission and reoperation rates and length of stay. Many studies have been able to derive these common outcome measures, but it may also be possible to produce indicators specific to neurosurgery. The aim of this observational study was firstly to describe the current pattern of neurosurgical admissions and procedures in England, and thereby given an overview of the epidemiology of neurosurgical patients. Secondly, it aims to investigate the range of outcome measures that might be produced from hospital administrative data and use these to assess the quality of care in neurosurgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
371,418

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

5 years

First QC Date

September 14, 2021

Last Update Submit

October 14, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Length of stay

    Length of the hospital admission to neurosurgery

    From date of admission to date of discharge from hospital; assessed up to 60 months.

  • Additional inpatient neurosurgical procedure rate

    A further neurosurgical procedure in admissions where patients have had a primary (main) neurosurgical procedure.

    From date of admission to date of discharge from hospital; assessed up to 60 months.

  • Proportion of patients discharged home

    Proportion of patients discharged to their normal address.

    Determined on date of discharge from hospital; assessed up to 60 months.

  • In-patient mortality rate

    In-patient mortality after a neurosurgical procedure.

    From date of the neurosurgical procedure through date of death from any cause (in-patient deaths only); assessed up to 60 months.

Study Arms (2)

Elective neurosurgery

Any elective neurosurgical procedure.

Procedure: Neurosurgical procedure

Non-elective neurosurgery

Any non-elective neurosurgical procedure.

Procedure: Neurosurgical procedure

Interventions

Any neurosurgical procedure in the National Neurosurgical Audit Programme (NNAP) Coding Framework of neurosurgical procedures.

Elective neurosurgeryNon-elective neurosurgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All admissions to neurosurgical units in the National Health Service (NHS) in England. This covers any patients in England who required neurosurgical care, except those admitted to Private Providers of neurosurgical care.

You may qualify if:

  • All admissions to neurosurgical units in the National Health Service (NHS) in England.

You may not qualify if:

  • Records with poor quality data (e.g. no data for clinical diagnoses).
  • Patients under 18 years that were admitted to an adult neurosurgical unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nervous System Diseases

Interventions

Neurosurgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Ryan Mathew

    University of Leeds

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and Consultant Neurosurgeon

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 27, 2021

Study Start

April 1, 2013

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

October 27, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share