The MERCURY Study demonstrated the accuracy, feasibility and reproducibility of Magnetic Resonance Imaging (MRI) to stage rectal cancer in a prospective, multidisciplinary, multi-centre study. However, there were differences in patient outcome, dependent upon the position of the tumour in the rectum and its height above the anal verge. Whilst the outcome was excellent for patients who underwent an anterior resection, the outcome, based upon margin involvement and quality of the specimen, was poor for patients who underwent an abdomino-perineal excision for low rectal cancer. It is proposed that accurate MRI staging pre-operatively will allow the correct patients to receive neo-adjuvant chemoradiotherapy (CRT), and also pre-warn the surgeons if the resection margins appear threatened so that the operation can be modified to take this into account. The primary aims of the Low Rectal Cancer Study (MERCURY II) are to assess the rate of CRM positivity rate in low rectal cancer and to assess the difference in global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation.
The aim of this study is to reduce the positive margin rate of 30% to around 15%. The study is an international multicentre, prospective, observational study, whereby patients with biopsy-proven low-rectal cancer (lower edge of the tumour \< 6cms from the anal verge on MRI), will be recruited from participating centres, having given informed, written consent. Data from the radiology, surgical and pathological aspects will be collected and analysed centrally at the Royal Marsden Hospital. The patient's medical records will be reviewed for five years post surgery, and the patients will also be followed up by quality of life questionnaires. This project aims to show that in low rectal cancer, improved local control and survival can be achieved through a reduction in the involved CRM rates by MRI-planned surgery and selective pre-operative therapy. It also aims to assess the ability to predict disease recurrence and to provide an assessment of disease-free survival and overall survival.
Study Type
OBSERVATIONAL
Enrollment
542
Vivantes Klinikum im Friedrichshain
Berlin, Germany
Krankenhaus Dresden-Friedrichstadt
Dresden, Germany
The First Surgical Clinic
Belgrade, Serbia
Milton Keynes General Hospital
Milton Keynes, Buckinghamshire, United Kingdom
Stepping Hill Hospital
Stockport, Cheshire, United Kingdom
North Hampshire Hospitals NHS Trust (Basingstoke Hospital)
Basingstoke, Hampshire, United Kingdom
West Middlesex University Hospital
Isleworth, Middlesex, United Kingdom
Weston General Hospital
Weston-super-Mare, Somerset, United Kingdom
Croydon University Hospital
Croydon, Surrey, United Kingdom
Frimley Park Hospital NHS Foundation Trust
Frimley, Surrey, United Kingdom
...and 7 more locations
To assess the rate of CRM positivity rate in low rectal cancer.
Time frame: 4 years
To compare global quality of life at two years post surgery in patients according to plane of surgery with or without sphincter preservation.
Time frame: 8 years
To compare patient reported outcomes in patients according to plane of surgery with or without sphincter preservation.
Time frame: 8 years
Analysis of the clinical and radiological factors influencing the decision by surgeons to carry out Anterior Resections, APE or extralevator APE.
Time frame: 8 years
Comparison of time to local recurrence, disease-free and overall survival between patients undergoing different types of surgery.
Time frame: 8 years
Comparison of imaging and pathology staging assessment, patient characteristics and complication rates, between different types of surgery and surgical approaches.
Time frame: 8 years
Investigation of potential associations between imaging and pathology assessment of radial and distal margins, neo-adjuvant chemoradiotherapy, perineal complications and sphincter preservation rates.
Time frame: 8 years
Investigation of potential association between length of operation with number of complications and length of post-operative ITU/HDU stay.
Time frame: 8 years
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