Hart trial
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Transcript of Hart trial
HART
Sum
mar
y Pr
esen
tatio
n, v
1.0,
23A
pr20
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
endm
ent
v3.0
, 19M
ar20
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