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.
NCT Number: NCT06443047
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Intra-procedural
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: up to 2 hours
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: 1 week
To assess, it will compare the proportion between the 2 groups of post-polypectomy syndrome at Day 7
Time frame: 1 month
Compare and assess the proportion of clinically significant delayed bleeding at 1 month
Time frame: 1 month
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
Time frame: up to 1 week
To compare the length of hospitalization defined as the number of procedural nights in the hospitals
Contact information is provided by the study sponsor or research team.
Alessandro D'Aprano, Dr.
CONTACT
Alessandro Repici, Prof.
CONTACT
Istituto Clinico Humanitas
Other
Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects: A Randomized Trial vs Conventional Clips That it Highlights the Importance of Suturing in Promoting Healing and Closure of the Colonic ESD Defects
Acronym: STITCH
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