Is risk prediction possible in head and neck free flap surgery?
| ISRCTN | ISRCTN11295626 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11295626 |
| Protocol serial number | N/A |
| Sponsor | Morriston Hospital |
| Funder | Investigator initiated and funded |
- 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
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
Scientific
Department of Oral and Maxillofacial Surgery
Morriston Hospital
Swansea
SA6 6NL
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective cohort |
| Secondary study design | Cohort study |
| Study type | Participant 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(s) |
30 day morbidity in head and neck free flap surgery. |
| Key secondary outcome measure(s) |
No secondary outcome measures. |
| Completion date | 04/08/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
ABMU Health Board
Heol Maes Eglwys
Swansea
SA6 6NL
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Newport
NP20 2UB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
