Colo-rectal Polyps Clinical Trial
Official title:
"Underwater" Technique With Submucosal Solution of Viscose Solution -SIC 8000 (EleviewTM) - For Endoscopic Resection of Cole-rectal Polyps With Signs of Fibrosis. Pilot Study
All procedures are performed in the investigator's outpatient gastroenterology and digestive
endoscopy unit by experienced endoscopists in conventional mucosectomies of the lower
intestinal tract.
Before the procedure each patient, a normal endoscopic procedure. At the site of the lesion
the lumen will be completely decompressed with aspiration of the gas, and then again relaxed
with the instillation of only water. The EleviewTM will be injected into the submucosa in
such quantities as to obtain a satisfactory lift of the lesion. The lesion will then be
removed with a diathermic loop, preferably en-bloc, and in any case up to macroscopic
evidence of complete resection. All the removed material will be stored and sent to
histological analysis. Tolerability score will be recorded during the procedure.
Any "bleeding" (both intra- and post-procedural), perforation, post-polypectomy syndrome,
stenosis or death in the 6 months following the procedure will be born "complication".
A surveillance colonoscopy including biopsy sampling of the research site scheduled 6 months
after the procedure
n/a