Cranio-PRO
Research type
Research Study
Full title
Patient-reported outcomes following cranioplasty: A cross-sectional cohort study
IRAS ID
291914
Contact name
Mohammad Arish Mustafa
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Operations involving the brain often require removing a piece of bone from the skull to provide access. Sometimes, this bone cannot be replaced at the end of the operation. A cranioplasty is an operation that is later performed to repair the defect in the skull commonly using a synthetic plate. Cranioplasty, like any other operation, might lead to changes both in physical and emotional well-being.
The aim of this study is to determine how patients feel about their physical, emotional health along with their physical appearance following cranioplasty.
Very little work has been carried out to assess quality of life following cranioplasty. This study will help doctors gain a better understanding of the long-term effects of this operation. This knowledge will help doctors to better understand the needs of patients, and will help doctors to provide better care for future patients.
To be eligible for the study participants must be over 16 years of age, have capacity to give consent, have had their cranioplasty on or after the 1st of January 2010, and be able to communicate using the English language. The Cranio-PRO study aims to recruit 296 participants.
Participants will be mailed a consent form and a participant information leaflet. After participants send back the completed consent form they will be mailed five questionnaires to complete and return. The questionnaires will assess overall quality of life, emotional well-being and participants' feelings regarding their own appearance. These questionnaires will take approximately 20 minutes to complete and can be done at the participants’ convenience.
This study will be conducted at The Walton Centre NHS Foundation Trust. Cranio-PRO is set to start on the 01/04/2020 and close on 01/10/2022. The study is set to last for 1 year and 6 months.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
21/YH/0019
Date of REC Opinion
27 Jan 2021
REC opinion
Further Information Favourable Opinion