国际临床自然腔道手术多中心试验——NOTES国际多中心试验研究：362例患者的初步结果
International multicenter trial on clinical natural orifice surgery--NOTES IMTN study: preliminary results of 362 patients.
作者信息
Zorron Ricardo, Palanivelu Chinnusamy, Galvão Neto Manoel Passos, Ramos Almino, Salinas Gustavo, Burghardt Jens, DeCarli Luis, Henrique Sousa Luiz, Forgione Antonello, Pugliese Raffaele, Branco Alcides J, Balashanmugan T S, Boza Camilo, Corcione Francesco, D'Avila Avila Fausto, Arturo Gómez Néstor, Galvão Ribeiro Paulo Ayrosa, Martins Susana, Filgueiras Marcos, Gellert Klaus, Wood Branco Anibal, Kondo William, Inacio Sanseverino Jose, de Sousa José Américo G, Saavedra Lil, Ramírez Edwin, Campos Josemberg, Sivakumar K, Rajan Pidigu Seshiyer, Jategaonkar Priyadarshan Anand, Ranagrajan Muthukumaran, Parthasarathi Ramakrishnan, Senthilnathan Palanisamy, Prasad Mohan, Cuccurullo Diego, Müller Verena
机构信息
Department of Surgery, University Hospital Teresopolis HCTCO-FESO, Rio de Janeiro, Brazil.
出版信息
Surg Innov. 2010 Jun;17(2):142-58. doi: 10.1177/1553350610370968.
OBJECTIVES
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.
目的
经自然腔道内镜手术（NOTES）正逐渐成为腹部手术一种有前景的替代方法。IMTN注册研究旨在前瞻性记录大量临床病例中自然腔道手术的早期结果。
方法
根据研究方案要求并经当地机构审查委员会批准，来自9个国家的16个中心被批准参与该研究。经胃和经阴道内镜自然腔道手术应用于362例患者。术中及术后参数被前瞻性记录。
结果
经阴道胆囊切除术的平均手术时间为96分钟，经胃胆囊切除术为111分钟。记录的总体并发症发生率为8.84%（I-II级占5.8%，III-IV级占3.04%）。四分之一的胆囊切除术和阑尾切除术患者无需任何镇痛。
结论
IMTN研究中NOTES的临床应用结果显示了这种新型微创替代腹腔镜手术和开放手术的不同方法的可行性。
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