NCT01498354

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

Comparing the Efficiency of Two Dimensional High Definition (TEO) Versus Three Dimensional (TEM) Endoscopic Systems in Transanal Endoscopic Surgery; a Prospective Control Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Adenoma

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2010-08-01
• Primary completion: 2010-10-01
• Completion: 2012-02-01
• First posted: 2011-12-23
• Last updated: 2019-04-18

Locations

1 site across 1 country: Spain