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

NCT01498354 | Completed

• 1 other identifier: TEO-TEM-2010-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Adenoma

Keywords

Transanal endoscopic microsurgery; Transanal endoscopic operations; Rectal adenomas; Transanal endoscopic surgery; Rectal adenocarcinomas "in situ"

Outcome Measures

Primary Outcomes (1)

• Cost per procedure assuming similar surgical efficacy and equal postoperative morbidity

  30 days

Study Arms (2)

2-D high definition TEO (transanal endoscopic operation)

EXPERIMENTAL

Procedure: 2-D high definition vision systems, transanal endoscopic operation (TEO)

Transanal endoscopic microsurgery (TEM)

ACTIVE COMPARATOR

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)

Interventions

2-D high definition vision systems, transanal endoscopic operation (TEO) PROCEDURE

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

2-D high definition TEO (transanal endoscopic operation)

Transanal endoscopic microsurgery (TEM) PROCEDURE

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

Transanal endoscopic microsurgery (TEM)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Corporacion Sanitaria Universitaria Parc Tauli

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

• 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.

  PMID: 24676506 DERIVED

MeSH Terms

Interventions

Transanal Endoscopic Microsurgery

Intervention Hierarchy (Ancestors)

Transanal Endoscopic Surgery; Natural Orifice Endoscopic Surgery; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Proctoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Digestive System Surgical Procedures; Surgical Procedures, Operative; Microsurgery; Minimally Invasive Surgical Procedures

Study Officials

• Xavier Serra-Aracil, MD

  Corporacion Sanitaria Universitaria Parc Tauli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 21, 2011
• First Posted: December 23, 2011
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: February 1, 2012
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

ES (1)