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.
Large superficial colonic polyps are increasingly detected thanks to colorectal cancer screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps. Nevertheless, several adverse events affect ESD, especially in the colon. They could be life-threatening, call for or prolong the hospitalization, require blood transfusion, additional endoscopic or surgical procedures and increase costs. Thus, preventing these adverse events is an important clinical and medico-economic objective. Endoscopic closure of post-ESD defects could reduce this risk. However, closing these large defects with conventional clips can be difficult, unsuccessful and prolong the duration of the whole procedure. A new trough-the-scope suturing system could successfully provide a complete endoscopic closure of post-ESD defects in the colon in a reasonable time. Expected benefits are a decrease of morbidity and costs related to colonic ESD procedure
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
66
The 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)
Time frame: Intra-procedural
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)
Time frame: up to 2 hours
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