International multicenter trial on clinical natural orifice surgery--NOTES IMTN study: preliminary results of 362 patients.
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.
Zorron
Ricardo
R
Department of Surgery, University Hospital Teresopolis HCTCO-FESO, Rio de Janeiro, Brazil. rzorron@terra.com.br
Palanivelu
Chinnusamy
C
Galvão Neto
Manoel Passos
MP
Ramos
Almino
A
Salinas
Gustavo
G
Burghardt
Jens
J
DeCarli
Luis
L
Henrique Sousa
Luiz
L
Forgione
Antonello
A
Pugliese
Raffaele
R
Branco
Alcides J
AJ
Balashanmugan
T S
TS
Boza
Camilo
C
Corcione
Francesco
F
D'Avila Avila
Fausto
F
Arturo Gómez
Néstor
N
Galvão Ribeiro
Paulo Ayrosa
PA
Martins
Susana
S
Filgueiras
Marcos
M
Gellert
Klaus
K
Wood Branco
Anibal
A
Kondo
William
W
Inacio Sanseverino
Jose
J
de Sousa
José Américo G
JA
Saavedra
Lil
L
Ramírez
Edwin
E
Campos
Josemberg
J
Sivakumar
K
K
Rajan
Pidigu Seshiyer
PS
Jategaonkar
Priyadarshan Anand
PA
Ranagrajan
Muthukumaran
M
Parthasarathi
Ramakrishnan
R
Senthilnathan
Palanisamy
P
Prasad
Mohan
M
Cuccurullo
Diego
D
Müller
Verena
V
D005260:Female; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods*; D019060:Minimally Invasive Surgical Procedures; D011446:Prospective Studies; D012042:Registries; D013270:Stomach / Q000601:surgery; D013997:Time Factors; D014621:Vagina / Q000601:surgery