HART

Sum

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1.0,

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15

Chief Investigator: Mr Jared Torkington*

Co-investigator: Ms Julie Cornish*

Co-investigator: Miss Rhiannon Harries*

Co-investigator: Mr Dave Bosenquet**

Trial Manager: Dr Buddug Rees*

*University Hospital of Wales, Cardiff

**Royal Gwent Hospital, Newport

Midline incision >5cm

Mass closure n=400

Hughes repair n=400

Primary objective: Incidence of incisional hernias at one year as assessed by clinical examination

HART Surgical Study

Colorectal cancer

Multi-centre, n~20

Clinical Study Report

4 years

Draft publication submitted

HART, Hughes Repair

The Hughes closure method, using a combination of sutures placed either closer to, or further from, the central incision. When the sutures are pulled to close the defect, the sutures lie both across and along the incision.

HART, Inclusion and Exclusion Criteria

Exclusion criteria • Unable to provide informed

consent

Inclusion criteria • Patients aged 18 years or older • Able to give informed consent • Both standard mass closure and

the Hughes repair closure are suitable closing techniques for the patient

• An elective patient for colorectal cancer surgery following full staging investigations including an abdominal CT scan

OR • An emergency patient with a

strong suspicion of colorectal cancer as per CT

HART, Inclusion and Exclusion Criteria at point of randomisation/closure

Exclusion criteria • Inserting a mesh as part of the

abdominal closure • Undergoing musculofascial flap

closure of perineal defect in abdomino-perineal wound closure

Inclusion criteria • Midline abdominal incision (open

or laparoscopic assisted/converted)

• Incision of 5cm or more

HART, patient activities

Screen all colorectal cancer patients due surgical treatment

At baseline, check eligibility and CT, obtain consent and gather information including QoL

Perform surgery, check eligibility and randomise for closure technique, and close

At 30 days, collect QoL data and surgical site infection diary

At 6 months, collect QoL data

At 1 year, undertake primary endpoint clinical examination, CT scan and collect QoL data

Screening Baseline Surgery Discharge 30 days 6 months 1 year

At discharge, collect post-surgical information

HART, timeline

Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May June Jul

2013 2015

STAR

T

2014

Feasibility phase

Recruitment*

Pilot/Main phase

Recruitment* FIN

ISH

STAR

T

Prot

ocol

Am

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ent

v3.0

, 19M

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15

Oth

er S

ite

Initi

atio

ns

*To date, the study has been conducted at single site: University Hospital of Wales, Cardiff

HART, next steps If interested please complete the ‘expression of interest’ form and return to the trial manager Please consider that you will need to identify the following people: • Principal Investigator • Coordinating Trainee, to work with trial manager, R&D, PI etc • Research Nurse

• Clinical Nurse Specialist

• Radiologist

• R&D contact to coordinate approval process