Transanal endoscopic microsurgery with 3-D (TEM) or high-definition 2-D transanal endoscopic operation (TEO) for rectal tumors. A prospective, randomized clinical trial.

PURPOSE: Transanal endoscopic microsurgery (TEM) is a three-dimensional viewing endoscopic system procedure which provides access to rectal tumors through a rectoscope. Two-dimensional transanal endoscopic operation (TEO), with the introduction of high-definition vision, achieves results that are comparable to those of the classical TEM. The main aim of the study was to compare the effectiveness of TEO and TEM systems in a prospective, randomized clinical trial. STUDY POPULATION: patients meeting inclusion criteria for diagnosis of rectal tumors with curative intent. Sample size, 36 patients. Patients were randomized to receive one of the two procedures. Study variables recorded were the following: preoperative data (time taken to assemble equipment, surgical time, quality of pneumorectum), postoperative morbidity and mortality, pathology study of the tumors, and economic analysis.
RESULTS: Thirty-six patients were analyzed according to intention to treat. Two patients were excluded. The final per-protocol analysis was 34 patients. There were no significant differences in the preoperative or operative variables, quality of pneumorectum, postoperative variables, or pathology results. A trend toward benefit was observed in favor of TEO in time required for assembly, surgical suture time, and total surgical time though the differences were not statistically significant. Statistically significant differences were found in terms of the total cost of the procedure, with mean costs of 2,031 <euro> ± 440 for TEO and 2,603 <euro> ± 507 for TEM (95% CI 218.15-926.486 <euro>, p = 0.003).
CONCLUSION: No technical or clinical differences were observed between the results obtained with the two systems except lower cost with TEO.

RCT Entities:   Population Interventions Outcomes