A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
OLV Ziekenhuis
Aalst, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
University Hospital
Ghent, Belgium
UZ Leuven
Leuven, Belgium
Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.
Time frame: Up to 15 weeks
Performance Rate of anastomotic leak (both radiological and clinical leaks)
Time frame: Up to 15 weeks post procedure or at stoma closure, whichever comes first
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