A limited endoscopoic assisted laparoscopic wedge resection of colon polyps is safe and effective.
ID
Bron
Verkorte titel
Aandoening
colon polyps, irradical endoscopic resection, endoscopic assisted wedge resection
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
safety of limited endoscopic assited laparoscopic wedge resection(EAWR)
Achtergrond van het onderzoek
The detection rate of colon polyps difficult to resect endoscopically is rising. Available techniques such as EMR/ESD are not applicable to all cases. Segmental colectomy is associated with significant morbidity and mortality.
Therefore, we introduced a limited endoscopy assisted laparoscopic wedge resections (EAWR) by using a linear stapler without anastomosis for the treatment of such polyps.
The objective is to study the safety and radicality of limited EAWR for the treatment of difficult colon polyps. Therefore, our primary endpoint is the 30-day morbidity after an EAWR. One of the secondary endpoints are the costs related with the procedure.
Doel van het onderzoek
A limited endoscopoic assisted laparoscopic wedge resection of colon polyps is safe and effective.
Onderzoeksopzet
- 30-day morbidity
- 6 months recurrence of adenomatous tissue by colonoscopy
Onderzoeksproduct en/of interventie
laparoscopic wedge resection and a colonoscopy during this intervention
Publiek
L.W. Leicher,
Dokter van Heesweg 2
Zwolle 8025 AB
The Netherlands
0031 38 424 5000
l.w.leicher@isala.nl
Wetenschappelijk
L.W. Leicher,
Dokter van Heesweg 2
Zwolle 8025 AB
The Netherlands
0031 38 424 5000
l.w.leicher@isala.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- A difficult non-invasive polyp that cannot be removed by standard EMR/ESD technique as assessed by an experienced gastroenterology expert panel
- A non-lifting recurrence of adenomatous tissue after irradical endoscopic removal.
- Resection of the scar after a prior endoscopic removal of an invasive T1 CRC without free resection margins but without high risk features of lymph node metastasis
- age of 18 years of older
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Pregnancy
- > 50% circumferential growth of the polyp in the lumen
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6200 |
| NTR-old | NTR6364 |
| Ander register | UMX Utrecht METC Approvel number : Reference 16-571 |