To analyse the efficacy and safety of two standard methods of endoscopic mucosal resection (EMR) for large non-pedunculated colorectal polyps, the investigators will compare submucosal injection-assisted endoscopic mucosal resection (SEMR) versus underwater endoscopic mucosal resection, without submucosal injection (UEMR).
Underwater endoscopic mucosal resection (UEMR) emerges as a variant of traditional resection, in which a submucosal cushion formation is not necessary. This technique was described in 2012 by Kenneth Binmoeller based on the physical floating effect of colonic mucous membrane by filling the colonic lumen using water instead of air. This "floating effect" conditions the natural separation of the colonic wall layers, allowing the distension of the submucosal space without the need to inject substances into it. On the other hand, performing resection in liquid medium conditions could drive the benefit of heat dissipation caused by the current, which would reduces thermal damage caused to the tissues.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
356
Polypectomy is performed under full water emersion avoiding the use of submucosal injection.
It will be performed in a 2-step procedure. First the formation of a submucosal injection underneath the polyp to create a submucosal safety cushion. Then EMR is performed with a polipectomy snare.
Hospital del Mar. Parc de Salut Mar
Barcelona, Spain
RECRUITINGHospital General Universitario de Ciudad Real
Ciudad Real, Spain
RECRUITINGLesion recurrence rate
Presence of polyp tissue at the same site as the original lesion (adenoma or sessile serrated polyp)
Time frame: 1 year
Technical success rate
Complete removal of polypoid tissue during the procedure
Time frame: 1 hour
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events (delated hemorrhage, perforation, hospital admission)
Time frame: 1 year
En bloc Resection rate
Rate of endoscopic mucosal resection in one piece during the procedure
Time frame: 1 hour
Procedure time
Time in minutes for the endoscopic mucosal resection
Time frame: 1 hour
Number of fragments
Number of fragments of the endoscopic mucosal resection
Time frame: 1 hour
Lesion size
Size of the lesion in millimeters
Time frame: 1 hour
Thermal artecfacts
Time frame: 1 hour
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.