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van CCT (UK)


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Limited surgival resection of colon polyps


- candidate number26528
- NTR NumberNTR6364
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jan-2017
- Secondary IDsReference 16-571 UMX Utrecht METC Approvel number
- Public TitleLimited surgival resection of colon polyps
- Scientific TitleLIMited wEdge ResectIon for Colon polyps
- ACRONYMLIMERIC
- hypothesisA limited endoscopoic assisted laparoscopic wedge resection of colon polyps is safe and effective.
- Healt Condition(s) or Problem(s) studiedColon polyps, Endoscopic resection
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2017
- planned closingdate1-jan-2019
- Target number of participants115
- Interventionslaparoscopic wedge resection and a colonoscopy during this intervention
- Primary outcomesafety 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
- Timepoints- 30-day morbidity
- 6 months recurrence of adenomatous tissue by colonoscopy
- Trial web sitewww.limeric.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. MD L.W. Leicher,
- CONTACT for SCIENTIFIC QUERIESDrs. MD L.W. Leicher,
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- Publications
- Brief summaryThe 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.

- Main changes (audit trail)
- RECORD24-jan-2017 - 19-jun-2017


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