Efficiency of Two Dimensional High Definition vs Three Dimensional Endoscopic Systems in Transanal Endoscopic Surgery
Primary Purpose
Rectal Adenoma
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
2-D high definition vision systems, transanal endoscopic operation (TEO)
Transanal endoscopic microsurgery (TEM)
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Adenoma focused on measuring Transanal endoscopic microsurgery, Transanal endoscopic operations, Rectal adenomas, Transanal endoscopic surgery, Rectal adenocarcinomas "in situ"
Eligibility Criteria
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.
Sites / Locations
- Corporacion Sanitaria Universitaria Parc Tauli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
2-D high definition TEO (transanal endoscopic operation)
Transanal endoscopic microsurgery (TEM)
Arm Description
Transanal endoscopic microsurgery (TEM), 3-D vision system using a rectoscope, which allows access to rectal tumors located up to 20 cm from the anal verge
Outcomes
Primary Outcome Measures
Cost per procedure assuming similar surgical efficacy and equal postoperative morbidity
Secondary Outcome Measures
Full Information
NCT ID
NCT01498354
First Posted
December 21, 2011
Last Updated
April 17, 2019
Sponsor
Corporacion Parc Tauli
1. Study Identification
Unique Protocol Identification Number
NCT01498354
Brief Title
Efficiency of Two Dimensional High Definition vs Three Dimensional Endoscopic Systems in Transanal Endoscopic Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Adenoma
Keywords
Transanal endoscopic microsurgery, Transanal endoscopic operations, Rectal adenomas, Transanal endoscopic surgery, Rectal adenocarcinomas "in situ"
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2-D high definition TEO (transanal endoscopic operation)
Arm Type
Experimental
Arm Title
Transanal endoscopic microsurgery (TEM)
Arm Type
Active Comparator
Arm Description
Transanal endoscopic microsurgery (TEM), 3-D vision system using a rectoscope, which allows access to rectal tumors located up to 20 cm from the anal verge
Intervention Type
Procedure
Intervention Name(s)
2-D high definition vision systems, transanal endoscopic operation (TEO)
Intervention Description
Transanal endoscopic operation (TEO). Through its 2-D vision system using a rectoscope, this procedure allows access to rectal tumors located up to 20 cm from the anal verge
Intervention Type
Procedure
Intervention Name(s)
Transanal endoscopic microsurgery (TEM)
Intervention Description
Transanal endoscopic microsurgery (TEM). 3-D vision system using a rectoscope, allowing access to rectal tumors located up to 20 cm from the anal verge
Primary Outcome Measure Information:
Title
Cost per procedure assuming similar surgical efficacy and equal postoperative morbidity
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Serra-Aracil, MD
Organizational Affiliation
Corporacion Sanitaria Universitaria Parc Tauli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporacion Sanitaria Universitaria Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24676506
Citation
Serra-Aracil X, Mora-Lopez L, Alcantara-Moral M, Caro-Tarrago A, Navarro-Soto S. Transanal endoscopic microsurgery with 3-D (TEM) or high-definition 2-D transanal endoscopic operation (TEO) for rectal tumors. A prospective, randomized clinical trial. Int J Colorectal Dis. 2014 May;29(5):605-10. doi: 10.1007/s00384-014-1849-3. Epub 2014 Mar 28.
Results Reference
derived
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Efficiency of Two Dimensional High Definition vs Three Dimensional Endoscopic Systems in Transanal Endoscopic Surgery
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