A Multicentre Trial of the Anterior Perineal PlanE for Ultra Low Anterior Resection of the Rectum (The APPEAR Technique) in the Prevention of Permanent Stoma in Benign and Malignant Disease
This study is recruiting patients with distal third rectal pathology, for whom a
conventional sphincter saving procedure is contraindicated, or likely to be technically
impossible.
Recruited patients will initially undergo trial dissection by conventional sphincter
preserving surgical techniques, which if successful will result in patients entering study
arm 1.
However, should this not be possible, a trial anterior perineal dissection will be
attempted, with patients entered into study arm 2 if perineal dissection is adequate to
allow full rectal excision, and preserve sphincter integrity.
If during a trial of anterior perineal dissection it is decided that sphincter preservation
is not safe, or will not allow eradication of rectal disease, conventional proctectomy will
be performed, with patients entering study arm 3.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Yield (within each arm of study)
5 years
No
Prof Norman S Williams, MS FRCS
Study Chair
Centre for Academic Surgery, Queen Mary University of London
United Kingdom: National Health Service
09/H0704/30
NCT00534131
April 2004
March 2012
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