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International multicenter trial on clinical natural orifice surgery--NOTES IMTN study: preliminary results of 362 patients. 2010
Ricardo Zorron, and
Chinnusamy Palanivelu, and
Manoel Passos Galvão Neto, and
Almino Ramos, and
Gustavo Salinas, and
Jens Burghardt, and
Luis DeCarli, and
Luiz Henrique Sousa, and
Antonello Forgione, and
Raffaele Pugliese, and
Alcides J Branco, and
T S Balashanmugan, and
Camilo Boza, and
Francesco Corcione, and
Fausto D'Avila Avila, and
Néstor Arturo Gómez, and
Paulo Ayrosa Galvão Ribeiro, and
Susana Martins, and
Marcos Filgueiras, and
Klaus Gellert, and
Anibal Wood Branco, and
William Kondo, and
Jose Inacio Sanseverino, and
José Américo G de Sousa, and
Lil Saavedra, and
Edwin Ramírez, and
Josemberg Campos, and
K Sivakumar, and
Pidigu Seshiyer Rajan, and
Priyadarshan Anand Jategaonkar, and
Muthukumaran Ranagrajan, and
Ramakrishnan Parthasarathi, and
Palanisamy Senthilnathan, and
Mohan Prasad, and
Diego Cuccurullo, and
Verena Müller
Department of Surgery, University Hospital Teresopolis HCTCO-FESO, Rio de Janeiro, Brazil. rzorron@terra.com.br
OBJECTIVE Natural orifice translumenal endoscopic surgery (NOTES) is evolving as a promising alternative for abdominal surgery. IMTN Registry was designed to prospectively document early results of natural orifice surgery among a large group of clinical cases. METHODS Sixteen centers from 9 countries were approved to participate in the study, based on study protocol requirements and local institutional review board approval. Transgastric and transvaginal endoscopic natural orifice surgery was clinically applied in 362 patients. Intraoperative and postoperative parameters were prospectively documented. RESULTS Mean operative time for transvaginal cholecystectomy was 96 minutes, compared with 111 minute for transgastric cholecystectomy. A general complication rate of 8.84% was recorded (grade I-II representing 5.8%, grade III-IV representing 3.04%). No requirement for any analgesia was found in one fourth of cholecystectomy and appendectomy patients. CONCLUSIONS Results of clinical applications of NOTES in the IMTN Study showed the feasibility of different methods of this new minimally invasive alternative for laparoscopic and open surgery.
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