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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xavier Serra-Aracil, Corporacion Parc Tauli
ClinicalTrials.gov Identifier:
NCT01498354
First received: December 21, 2011
Last updated: November 8, 2012
Last verified: November 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Corporacion Parc Tauli:

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

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Corporacion Parc Tauli

Additional 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
Study First Received: December 21, 2011
Last Updated: November 8, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by 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

ClinicalTrials.gov processed this record on August 28, 2014