No registrations found.
ID
Source
Brief title
Health condition
full-thickness resection
FTR
recurrent fibrosed adenoma
Sponsors and support
results, and the decision to publish results.
Intervention
Outcome measures
Primary outcome
• R0-resection rate [Timepoint: 2 weeks]
• Full-thickness resection rate [Timepoint: 2 weeks]
• Complication rate [Timepoint: 30 days]
Secondary outcome
• Recurrence at 6 months follow-up [Timepoint: 6 months]
• Patients experience 7 days after resection [Timepoint: 7 days]
• Patients experience 30 days after resection [Timepoint: 30 days]
Study objective
The aim of this study is to prospectively test the safety and feasibility of endoscopic full-thickness resection in the colon using the Pro-select Padlock clip.
Study design
• R0-resection rate [Timepoint: 2 weeks]v
• Full-thickness resection rate [Timepoint: 2 weeks]
• Complication rate [Timepoint: 30 days]
• Recurrence at 6 months follow-up [Timepoint: 6 months]
• Patients experience 7 days after resection [Timepoint: 7 days]
• Patients experience 30 days after resection [Timepoint: 30 days]
Intervention
Endoscopic full-thickness resection with the ProSelect PadLock clip in the colon.
Yara Backes
Kamernummer Q04.4.43, Postbus 85500
Utrecht 3508 GA
The Netherlands
+31 88 75 507 22
Y.Backes@umcutrecht.n
Yara Backes
Kamernummer Q04.4.43, Postbus 85500
Utrecht 3508 GA
The Netherlands
+31 88 75 507 22
Y.Backes@umcutrecht.n
Inclusion criteria
• ≥18 years old
• informed consent
• Indication for full-thickness resection: recurrent fibrosed adenoma, adenoma located in diverticula, SET of the colon, Rx/R1 endoscopic resection of a T1 CRC
Exclusion criteria
• Target lesions > 20 mm
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5428 |
| NTR-old | NTR5562 |
| Other | : 15-419 |