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TRANSANAL ENDOSCOPIC MICROSURGERY VERSUS ENDOSCOPIC MUCOSAL RESECTION FOR LARGE RECTAL ADENOMAS


- candidate number3878
- NTR NumberNTR1422
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-aug-2008
- Secondary IDsMEC 08/183 # 08.17.1104  ZonMw: 17099.2201
- Public TitleTRANSANAL ENDOSCOPIC MICROSURGERY VERSUS ENDOSCOPIC MUCOSAL RESECTION FOR LARGE RECTAL ADENOMAS
- Scientific TitleTRANSANAL ENDOSCOPIC MICROSURGERY VERSUS ENDOSCOPIC MUCOSAL RESECTION FOR LARGE RECTAL ADENOMAS
- ACRONYMTREND study
- hypothesisTransanal endoscopic microsurgery and extended EMR are both effective treatments for large rectal adenomas with comparable recurrence rates. However, EMR does not require general/spinal anesthesia or hospital admission and may be associated with lower morbidity. Therefore, EMR may improve quality of life and reduce health care costs.
- Healt Condition(s) or Problem(s) studiedAdenomas, Endoscopic mucosa resection, Rectal adenomas , Microsurgery
- Inclusion criteria1. Large non-pedunculated rectal adenoma with a diameter of at least 3cm
2. Located between 1-15cm from the anal verge
3. Biopsies of the lesion did not show invasion of neoplastic tissue in the submucosal layer
4. Flexible video endoscopy or rigid proctoscopy plus endoscopic ultrasonography exclude suspicion of invasive submucosal cancer
5. total colonoscopy will be done to detect and remove all synchronous colonic neoplasia first
6. ASA-classification I-III
7. Absence of non-correctable coagulopathy
8. Patient age of 18 years or older
- Exclusion criteria- See inclusion criteria
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2009
- planned closingdate1-jan-2013
- Target number of participants184
- InterventionsTransanal endoscopic microsurgery (TEM) according to Buess; and endoscopic mucosal resection (EMR) with submucosal injection of NaCl (according to Karita)
- Primary outcome- Proportion of patients with recurrence (2 year follow up)
- The number of days that a patient is alive, outside the hospital and free of recurrence during a two-year follow-up period starting at the day of the initial treatment
- Secondary outcome- Complications
- Generic and disease specific healt related quality of life
- Costs
- TimepointsStart inclusion: 1-1-2009
Stop inclusion: 1-10-2011
Stop follow up: 1-1-2013
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD, PhD Evelien Dekker
- CONTACT for SCIENTIFIC QUERIESMD, PhD Evelien Dekker
- Sponsor/Initiator Academic Medical Center (AMC), Department of Hepato- and Gastroenterology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryMulticenter randomized trial comparing the cost-effectiveness and cost-utility of TEM versus EMR for resection of large (>=3cm) rectal adenomas.
- Main changes (audit trail)
- RECORD28-aug-2008 - 8-sep-2008


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