The HART Surgical Study is a multi-centre clinical trial investigating two closure techniques - mass closure versus Hughes repair - to assess the incidence of incisional hernias at one year in patients undergoing surgery for colorectal cancer. The trial has recruited patients at the University Hospital of Wales in Cardiff and is seeking to expand to other sites. Interested sites should complete an expression of interest form identifying key personnel and contacts to facilitate the trial approval and initiation process at their centre.

1. HARTSummaryPresentation,v1.0,23Apr2015
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

2. 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
4years
Draft publication submitted

3. 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.

4. 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

5. 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

6. 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

7. 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
START
2014
Feasibility
phase
Recruitment*
Pilot/Main
phase
Recruitment*
FINISH
START
ProtocolAmendment
v3.0,19Mar2015
OtherSite
Initiations
*To date, the study has been conducted at single site:
University Hospital of Wales, Cardiff

8. 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