The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips.
Patient suffering from 30-60 mm colonic polyps with indication of ESD
Male or female patients aged > 18 years' old
Patients able to fill in questionnaires written in Italian
Failure of endoscopic resection
Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn)
Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)
Polyp inside the ileo-cecal valvula.
Parallel
TTS suturing system
DeviceThe use of TTS suturing system could allow a quick, complete endoscopic closure of colonic post-ESD defects, providing relevant clinical and medico-economic benefits.
Compare the proportion of complete closure between the two groups
To assess the proportion of complete closure, defined when opposite margins are drawn together without a persistent post-resection defect of more than 1 cm (pictures and/or videos)
duration of the closure procedure
To assess the closure procedure time, which is defined by duration between the beginning of assemblage of the suturing system and the end of the closure in the intervention group and between the opening of the bag of the first clip until the end of the closure in the control group.(pictures-videos)
Proportion of post-polypectomy syndrome
To assess, it will compare the proportion between the 2 groups of post-polypectomy syndrome at Day 7
Proportion of clinically significant delayed bleeding
Compare and assess the proportion of clinically significant delayed bleeding at 1 month
Cost-effectiveness ratio
To assess the cost-effectiveness ratio, estimated by dividing the difference in costs observed between the two strategies by the difference of effectiveness at 1 month. The effectiveness criterion being the closure time at 1 month
Length of hospitalization
To compare the length of hospitalization defined as the number of procedural nights in the hospitals
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This trial is not recruiting at the moment. You can still explore other options:
