Status:
COMPLETED
Efficiency of Two Dimensional High Definition vs Three Dimensional Endoscopic Systems in Transanal Endoscopic Surgery
Lead Sponsor:
Corporacion Parc Tauli
Conditions:
Rectal Adenoma
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01498354
Start Date
August 1 2010
End Date
February 1 2012
Last Update
April 18 2019
Active Locations (1)
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1
Corporacion Sanitaria Universitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208