Abstract
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.
Method
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 € ± 440 for TEO and 2,603 € ± 507 for TEM (95 % CI 218.15–926.486 €, p = 0.003).
Conclusion
No technical or clinical differences were observed between the results obtained with the two systems except lower cost with TEO.
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Acknowledgments
We would like to thank the members of the Coloproctology Unit, Dr Jordi Bombardó, Isidro Ayguavives, and Marina Retamar, and the residents at the Coloproctology Unit who followed the study protocol. We also thank Cristina Gomez-Vigo for correcting the manuscript and to Michael Maudsley for the translation into English. We are grateful to the nurses of the Surgery Unit for their support in the use of the procedures.
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Trial registration: ClinicalTrials.gov. Registration number: NCT01498354. Name of trial registry: Efficiency of Two Dimensional High Definition Versus Three Dimensional Endoscopic Systems in Transanal Endoscopic Surgery. URL:http://www.clinicaltrials.gov.
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Serra-Aracil, X., Mora-Lopez, L., Alcantara-Moral, M. et al. 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 29, 605–610 (2014). https://doi.org/10.1007/s00384-014-1849-3
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DOI: https://doi.org/10.1007/s00384-014-1849-3