Condition category
Surgery
Date applied
28/03/2015
Date assigned
06/05/2015
Last edited
01/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Neil Scott

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

POSSUM in HNFFS

Study hypothesis

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

Wales REC, 20/04/2015, ref: 15/WA/0136.

Study design

Prospective cohort

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format . Please use the contact details to request a patient information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

30 day morbidity in head and neck free flap surgery.

Secondary outcome measures

No secondary outcome measures.

Overall trial start date

01/10/2014

Overall trial end date

04/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing head and neck free flap surgical reconstruction for oral cancer.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

Patients NOT undergoing head and neck free flap surgical reconstruction for oral cancer.

Recruitment start date

03/08/2015

Recruitment end date

04/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Trial participating centre

University Hospital Wales
Heath Park
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Royal Gwent Hospital
Cardiff Road
Newport
NP20 2UB
United Kingdom

Sponsor information

Organisation

Morriston Hospital

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

01/01/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes