The goal of this clinical trial is to determine whether the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon is feasible and safe. The main questions it aims to answer are: * Is the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon feasible (i.e., does it enable complete resection of the polyp)? * Is the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon safe? Participants will: * be treated with the EndoTEM system during the endoscopic submucosal dissection of polyps in the distal colon. * answere questionnaires on fecal continence and quality of life before and after the intervention. * be treated following standard clinical procedures before, during and after the endoscopic removal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
EndoTEM is a flexible transanally introduced port system that allows the insertion of a second instrument alongside the flexible endoscope. A curved rigid grasping instrument has been developed, with a 2 cm long tip that can be rotated and angled in all directions.
Universitätsklinikum Freiburg, Klinik für Innere Medizin II
Freiburg im Breisgau, Germany
RKH Klinikum Ludwigsburg
Ludwigsburg, Germany
Robert Bosch Krankenhaus GmbH
Stuttgart, Germany
Technical success of the endoscopic resection
Macroscopically complete resection.
Time frame: From the endoscopic resection to the follow-up endoscopy after 6 months.
R0 resection rate
Histological complete resection.
Time frame: Assessed with a biopsy collected during the intervention.
En bloc resection rate
Endoscopic removal of the polyp in one intact piece, including any necessary surrounding tissue.
Time frame: Assessed during the intervention.
Duration of the procedure
Time frame: From endoscope insertion until the end of procedure including supplementary and prophylactic interventions.
Resection time
Time frame: From start of the resection until detachment of the specimen.
Resection speed
Resected area per minute (mm²/min).
Time frame: Assessed during the intervention.
Periprocedural complications
Time frame: Complications that occur during or immediately around the intervention (until 3-6 months post-intervention).
Requirement for surgical intervention
Time frame: During the endoscopic submucosal dissection.
Rate of recurrence
Time frame: Assessed during follow-up endoscopy 3-6 months post-intervention.
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