Transanal 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…
ID
Bron
Verkorte titel
Aandoening
Large rectal adenomas of at least 3 cm in diameter; invasive submucosal cancer is being excluded.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Proportion of patients with recurrence (2 year follow up)<br>
- 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
Achtergrond van het onderzoek
Multicenter randomized trial comparing the cost-effectiveness and cost-utility of TEM versus EMR for resection of large (>=3cm) rectal adenomas.
Doel van het onderzoek
Transanal 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.
Onderzoeksopzet
Start inclusion: 1-1-2009
Stop inclusion: 1-10-2011
Stop follow up: 1-1-2013
Onderzoeksproduct en/of interventie
Transanal endoscopic microsurgery (TEM) according to Buess; and endoscopic mucosal resection (EMR) with submucosal injection of NaCl (according to Karita)
Publiek
Department of Gastroenterology and Hepatology <br>
P.O. Box 22660
Evelien Dekker
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664702
e.dekker@amc.uva.nl
Wetenschappelijk
Department of Gastroenterology and Hepatology <br>
P.O. Box 22660
Evelien Dekker
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5664702
e.dekker@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- See inclusion criteria
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1361 |
| NTR-old | NTR1422 |
| Ander register | ZonMw: 17099.2201 : MEC 08/183 # 08.17.1104 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |