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Comparing the Efficiency of Two Dimensional High Definition (TEO) Versus Three Dimensional (TEM) Endoscopic Systems in Transanal Endoscopic Surgery; a Prospective Control Trial


Phase 3
18 Years
90 Years
Not Enrolling
Both
Rectal Adenomas and Adenocarcinomas "in Situ"

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Trial Information

Comparing the Efficiency of Two Dimensional High Definition (TEO) Versus Three Dimensional (TEM) Endoscopic Systems in Transanal Endoscopic Surgery; a Prospective Control Trial


Inclusion Criteria:



- Patients of either sex older than 18 years

- Rectal tumor identified as rectal adenoma by multifocal biopsy using colonoscopy,
with endorectal ultrasound and magnetic resonance imaging findings of non-invasive
tumor.

- Size of the tumor between 2 and 6 cm in maximum diameter.

- Tumor location, lower edge at least 2 cm from the anal verge, and upper edge at least
15 cm from the anal verge.

- ASA score more than III.

- intervention was performed under general anesthesia

Exclusion Criteria:

- Invasive adenocarcinoma shown in the final pathology study. "in situ" or
intraepithelial adenocarcinomas are not excluded .

- Pregnant patients

- Patients with liver cirrhosis or blood dyscrasia.

- Patients who can not be administered under general anesthesia.

- Patients on antiplatelet or anticoagulation therapy who have not been properly
prepared for surgery.

- Presence of two or more transanal endoscopic excisions in the same procedure.

- Informed consent not signed.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Cost per procedure assuming similar surgical efficacy and equal postoperative morbidity

Outcome Time Frame:

30 days

Safety Issue:

Yes

Principal Investigator

Xavier Serra-Aracil, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Corporacion Sanitaria Universitaria Parc Tauli

Authority:

Spain: Comité Ético de Investigación Clínica

Study ID:

TEO-TEM-2010-01

NCT ID:

NCT01498354

Start Date:

August 2010

Completion Date:

February 2012

Related Keywords:

  • Rectal Adenomas and Adenocarcinomas "in Situ"
  • Transanal endoscopic microsurgery
  • Transanal endoscopic operations
  • Rectal adenomas
  • Transanal endoscopic surgery
  • Rectal adenocarcinomas "in situ"
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Adenoma

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