No registrations found.
ID
Source
Brief title
Health condition
colon polyps, irradical endoscopic resection, endoscopic assisted wedge resection
Sponsors and support
Intervention
Outcome measures
Primary outcome
safety of limited endoscopic assited laparoscopic wedge resection(EAWR)
Secondary outcome
- effectiveness of EAWR, defined as the number of radical resection (margin of normal colonic mucosa of at least 1mm)
- morbidity of limited EAWR 3 months after the procedure
- recurrence rate at 6 months
- total procedure related costs of limited EAWR
- implementation of limited EAWR in the Netherlands
Background summary
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.
Study objective
A limited endoscopoic assisted laparoscopic wedge resection of colon polyps is safe and effective.
Study design
- 30-day morbidity
- 6 months recurrence of adenomatous tissue by colonoscopy
Intervention
laparoscopic wedge resection and a colonoscopy during this intervention
L.W. Leicher,
Dokter van Heesweg 2
Zwolle 8025 AB
The Netherlands
0031 38 424 5000
l.w.leicher@isala.nl
L.W. Leicher,
Dokter van Heesweg 2
Zwolle 8025 AB
The Netherlands
0031 38 424 5000
l.w.leicher@isala.nl
Inclusion criteria
- 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
Exclusion criteria
- Pregnancy
- > 50% circumferential growth of the polyp in the lumen
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 | NL6200 |
| NTR-old | NTR6364 |
| Other | UMX Utrecht METC Approvel number : Reference 16-571 |