TESD Pilot study - TEM vs. ESD
Not Applicable
Recruiting
- Conditions
- D12.8C20RectumMalignant neoplasm of rectum
- Registration Number
- DRKS00006125
- Lead Sponsor
- niverisitätsmedizin MannheimZentrale Interdisziplinäre Endoskopie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Non-pedunculated adenomas of the rectum > 15mm, < 40% of the circumference
Low-risk rectum carcinoma
Randomizable in regard to TEO or ESD (ventral up to 10 cm a.a., dorsal up to 14 cm a.a.)
Exclusion Criteria
Recurrence after malignoma
Other malginant tumors
Ulcerative colitis, FAP, HNPCC
Patient without possibility for written consent
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence after 12 month
- Secondary Outcome Measures
Name Time Method Rate of en-bloc-resection<br>Rate of R0-resection<br>Hospital stay<br>Complications (Clavien)<br><br>Quality of life (GIQLI) and incontinence (Wexner) by questionnaire preoperative and 3, 6 and 12 month postoperative.<br>