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.
ID
Bron
Verkorte titel
Aandoening
full-thickness resection
FTR
recurrent fibrosed adenoma
Ondersteuning
results, and the decision to publish results.
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
• R0-resection rate [Timepoint: 2 weeks]<br>
• Full-thickness resection rate [Timepoint: 2 weeks]<br>
• Complication rate [Timepoint: 30 days]
Doel van het onderzoek
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.
Onderzoeksopzet
• 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]
Onderzoeksproduct en/of interventie
Endoscopic full-thickness resection with the ProSelect PadLock clip in the colon.
Publiek
Yara Backes
Kamernummer Q04.4.43, Postbus 85500
Utrecht 3508 GA
The Netherlands
+31 88 75 507 22
Y.Backes@umcutrecht.n
Wetenschappelijk
Yara Backes
Kamernummer Q04.4.43, Postbus 85500
Utrecht 3508 GA
The Netherlands
+31 88 75 507 22
Y.Backes@umcutrecht.n
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• ≥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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Target lesions > 20 mm
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL5428 |
NTR-old | NTR5562 |
Ander register | : 15-419 |