We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficiency of Two Dimensional High Definition Versus Three Dimensional Endoscopic Systems in Transanal Endoscopic Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498354
First Posted: December 23, 2011
Last Update Posted: September 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Xavier Serra-Aracil, Corporacion Parc Tauli
  Purpose

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.


Condition Intervention Phase
Rectal Adenomas and Adenocarcinomas "in Situ" Procedure: 2-D high definition vision systems, transanal endoscopic operation (TEO) Procedure: Transanal endoscopic microsurgery (TEM) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Xavier Serra-Aracil, Corporacion Parc Tauli:

Primary Outcome Measures:
  • Cost per procedure assuming similar surgical efficacy and equal postoperative morbidity [ Time Frame: 30 days ]

Enrollment: 36
Study Start Date: August 2010
Study Completion Date: February 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2-D high definition TEO (transanal endoscopic operation) Procedure: 2-D high definition vision systems, transanal endoscopic operation (TEO)
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
Active Comparator: Transanal endoscopic microsurgery (TEM)
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
Procedure: Transanal endoscopic microsurgery (TEM)
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01498354


Locations
Spain
Corporacion Sanitaria Universitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208
Sponsors and Collaborators
Corporacion Parc Tauli
Investigators
Principal Investigator: Xavier Serra-Aracil, MD Corporacion Sanitaria Universitaria Parc Tauli
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xavier Serra-Aracil, Medical Doctor, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT01498354     History of Changes
Other Study ID Numbers: TEO-TEM-2010-01
First Submitted: December 21, 2011
First Posted: December 23, 2011
Last Update Posted: September 10, 2015
Last Verified: September 2015

Keywords provided by Xavier Serra-Aracil, Corporacion Parc Tauli:
Transanal endoscopic microsurgery
Transanal endoscopic operations
Rectal adenomas
Transanal endoscopic surgery
Rectal adenocarcinomas "in situ"

Additional relevant MeSH terms:
Adenocarcinoma
Adenoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms