D12.8 C20
Conditions
Interventions
Group 1: Transanal endoscopic microsurgery (TEM)
Group 2: Endoscopic submucosal dissection (ESD)
Sponsors
Univerisitätsmedizin MannheimZentrale Interdisziplinäre Endoskopie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria: Recurrence after malignoma Other malginant tumors Ulcerative colitis, FAP, HNPCC Patient without possibility for written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence after 12 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of en-bloc-resection Rate of R0-resection Hospital stay Complications (Clavien) Quality of life (GIQLI) and incontinence (Wexner) by questionnaire preoperative and 3, 6 and 12 month postoperative. | — |
Countries
Germany
Contacts
Public ContactMoritz Sold
Universitätsmedizin MannheimZentrale Interdisziplinäre Endoskopie
Outcome results
None listed