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

Sponsor

Corporacion Parc Tauli (Other)

Overall Status

Completed

CT.gov ID

NCT01498354

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Adenoma	Procedure: 2-D high definition vision systems, transanal endoscopic operation (TEO) Procedure: Transanal endoscopic microsurgery (TEM)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

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

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Cost per procedure assuming similar surgical efficacy and equal postoperative morbidity [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.