endoscopic full thickness resection colorectal polyp colorectal adenoma colonoscopy Nederlands: endoscopische full thickness resectie colorectale poliep colorectaal adenoom coloscopie
Conditions
Interventions
There will be no formal interventions in this study, since this is a prospective registration of endoscopic full-thickness resection, wherefore the indication for this procedure is already set by an t
Sponsors
Academic Medical Center Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: We will prospectively include all patients who are scheduled to undergo an eFTR procedure with the FTRD performed by one of the trained endoscopists in the Netherlands. In order to be eligible to be included in this study a patient must meet all of the following criteria: - Scheduled to undergo eFTR procedure with the FTRD performed by one of the trained endoscopists in performing FTRD procedures in the Netherlands
Exclusion criteria
Exclusion criteria: There are no formal exclusion criteria since the indication for a full thickness resection of all patients was already set by a trained endoscopist in the Netherlands.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our main study endpoint is the technical success rate of all scheduled eFTR procedures with the FTRD defined as the number of patients with a complete endoscopic en bloc resection in the Netherlands. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary study parameters are designed to further study the technical success, the applicability and the safety of all eFTR procedures in the Netherlands; - The number of patients with histologically confirmed R0 resection defined as negative lateral and deep margins - The number of patients with a histologically confirmed full thickness resection - The number of eFTR procedures in which the procedure was not technical succesfull, due to the inability to reach the lesion, the inability to retract all the tissue in the FTRD and technical difficulties with the FTRD - Number of intra procedural complications, defined as any perforation or a bleeding for which an additional intervention, defined as transfusion, admission, radiologic intervention or surgical treatment is required - Number of patients with early (48 hours) and late (until 14 days) postprocedural complications for which additional treatment is necessary, defined as presentation at the emergency ward, transfusion, admission, repeat endoscopy, radiologic intervention or surgical treatment - The occurrence of recurrence during follow-up colonoscopies - Procedural time | — |
Contacts
Public ContactMaxime E.S. Bronzwaer
Meibergdreef 9
Outcome results
None listed