Rectal Adenoma Clinical Trial
Official title:
Comparing the Efficiency of Two Dimensional High Definition (TEO) Versus Three Dimensional (TEM) Endoscopic Systems in Transanal Endoscopic Surgery; a Prospective Control Trial
Introduction: The usual surgical technique for large adenomatous tumors and rectal cancer is
anterior resection of the rectum or abdominoperineal resection. These techniques are
associated with high mortality and morbidity and with genitourinary dysfunctions.
To solve these problems, transanal endoscopic microsurgery (TEM) was designed. Through its
3-D vision system using a rectoscope, this procedure allows access to rectal tumors located
up to 20 cm from the anal verge. It is associated with minimal morbidity and has few
repercussions for anal continence.
The use of 2-D high definition cameras and screens obtains images of a similar quality to 3-D
images. This means that from the surgical point of view the procedure known as TEO (transanal
endoscopic operation) seems as practicable as classic TEM.
Main aim: To assess the effectiveness of 2-D high definition vision systems (TEO) versus
conventional 3-D (TEM) in endoscopic surgery of rectal tumors, with respect to surgical
facility, postoperative morbidity, quality of the surgical specimens, and cost.
Design: Prospective, controlled, randomized study of the efficacy of the use of 2-D high
definition endoscopic systems versus 3-D (TEM) in transanal endoscopic surgery.
Disease studied: Rectal adenomas and adenocarcinomas "in situ" suitable for local surgery.
Main variable evaluated: Cost per procedure assuming similar surgical efficacy and equal
postoperative morbidity.
Study population and total number of patients: Patients diagnosed with rectal tumor treated
with curative intent (rectal adenomas and adenocarcinomas "in situ"). The total sample
calculated for the trial was 36 patients, 18 in each group (TEO and TEM).
Timing and expected finish date: After approval by the CEIC, the expected date for the
inclusion of the first patient was August 2010. The study is expected to last 18-24 months.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04651764 -
Transanal Resection of Rectal Lesions With the ColubrisMX ELS System
|
N/A | |
| Completed |
NCT06158776 -
Predicting Rectal Adenoma With Canceration and Investigating Mechanism Based on Multimodal MRI and Biochemical Model
|
||
| Not yet recruiting |
NCT02579330 -
Trial on Use of Coloshield in Transanal and Anal Surgery
|
N/A |