Is risk prediction possible in head and neck free flap surgery?

ISRCTN	ISRCTN11295626
DOI	https://doi.org/10.1186/ISRCTN11295626
Secondary identifying numbers	N/A

Submission date: 28/03/2015
Registration date: 06/05/2015
Last edited: 01/05/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Being able to predict the risk of complications or death associated with surgery is becoming more important because it helps inform patients about the possible outcomes of their operation. It also provides a way to assess how successful a surgeon or hospital unit is. The Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM) is widely used to calculate risk in general surgery. However, there is currently no way to calculate the risk of Head and Neck Free Flap Surgery (HNFFS) because POSSUM scoring in HNFFS is thought to be not very accurate. This means that doctors cannot provide patients with a personalised percentage risk of complications or death before they have their HNFFS. This study aims to formulate an equation that will enable researchers to develop such a risk calculation.

Who can participate?
All patients in South Wales undergoing HNFFS for cancer.

What does the study involve?
This study only involves data collection and does not alter a patient’s treatment plan in anyway. Data is collected at three points: before surgery, on the day of/during surgery and throughout the hospital stay. Participants are asked to complete various questionnaires related to lifestyle and health history.

What are the possible benefits and risks of participating?
The results of the study will not benefit participants directly. However, it will allow future head and neck cancer patients to be given a percentage risk calculation of possible complications and death related to their surgery which might assist in their decision making. There are no side effects or risks to patients.

Where is the study run from?
1. Morriston Hospital Wales (UK)
2. University Hospital Wales (UK)
3. Royal Gwent Hospital Wales (UK)

When is the study starting and how long is it expected to run for?
August 2015 to August 2017

Who is funding the study?
Investigator initiated and funded (UK)

Who is the main contact?
Mr N Scott (UK)
NeilThomas.Scott@Wales.nhs.uk

Contact information

Mr Neil Scott
Scientific

Department of Oral and Maxillofacial Surgery
Morriston Hospital
Swansea
SA6 6NL
United Kingdom

Study information

Study design	Prospective cohort
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format . Please use the contact details to request a patient information sheet.
Scientific title	Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM): a tool to predict morbidity & mortality in Head & Neck Free Flap Surgery
Study acronym	POSSUM in HNFFS
Study objectives	Risk prediction (morbidity and mortality) is possible in Head and Neck Free Flap Surgery using an adapted Physiological and Operative Severity Score for the enUmeration of Mortality and Morbidity (POSSUM) risk assessment calculation.
Ethics approval(s)	Wales REC, 20/04/2015, ref: 15/WA/0136.
Health condition(s) or problem(s) studied	Risk prediction in patients undergoing free flap reconstruction surgery following oral cancer surgical resection.
Intervention	1. Pre-operative data: age, smoking history; alcohol history; Performance Status questionnaire; Adult Co-morbidity Evaluation (ACE-27); previous surgery to head and neck; previous radiotherapy to head and neck; tumour stage and nodal status. 2. Peri-operative data: duration of surgery; type of free flap; blood loss; tracheostomy performed; ischaemic time of free flap. 3. Post-operative data: all patient complications are recorded.
Intervention type	Other
Primary outcome measure	30 day morbidity in head and neck free flap surgery.
Secondary outcome measures	No secondary outcome measures.
Overall study start date	01/10/2014
Completion date	04/08/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	300
Key inclusion criteria	Patients undergoing head and neck free flap surgical reconstruction for oral cancer.
Key exclusion criteria	Patients NOT undergoing head and neck free flap surgical reconstruction for oral cancer.
Date of first enrolment	03/08/2015
Date of final enrolment	04/08/2017

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centres

Morriston Hospital

Morriston Hospital
ABMU Health Board
Heol Maes Eglwys
Swansea
SA6 6NL
United Kingdom

University Hospital Wales

Heath Park
Cardiff
CF14 4XW
United Kingdom

Royal Gwent Hospital

Cardiff Road
Newport
NP20 2UB
United Kingdom

Sponsor information

Morriston Hospital
Hospital/treatment centre

Research and Development Department
ABMU Health Board
Swansea
SA6 6NL
Wales
United Kingdom

"ROR"	https://ror.org/01p830915

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/01/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	The study will be written up as a full length article and submitted to the British Journal of Oral and Maxillofacial Surgery or Head and Neck. It will also be submitted to appropriate conferences for oral presentation.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No