IMTN Study- International Prospective Multicenter Trial on Clinical NOTES

Gastrointestinal Surgery Clinical Trial

— IMTN  

Official title:

IMTN Study- International Prospective Multicenter Trial on Clinical NOTES

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00995735
• Other study ID #: 0209.0.314.000-08
• Status: Recruiting
• Phase: N/A
• First received: October 14, 2009
• Last updated: October 14, 2009
• Start date: June 2007
• Est. completion date: December 2009

Study information

• Verified date: October 2009
• Source: IMTN NOTES Research Group
• Contact: Ricardo Zorron, MD, PhD
• Phone: +552191914698
• Email: rzorron[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Objectives: Since 2007, natural orifice surgery evolved from theory and animal research to clinical applications, but is still limited in the literature to small casuistic reports. A preliminary prospective evaluation of postoperative results of the early casuistic of Natural orifice Surgery for many indications may show advantages and disadvantages of the methods. The IMTN Multicenter Trial for Clinical NOTES was and early results are described.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients submitted to elective surgery

Exclusion Criteria:

• emergency surgery High ASA risk patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Surgery
• Natural Orifice Surgery

Intervention

Procedure:
• Cholecystectomy
Cholecystectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.
• Appendectomy
Appendectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.

Locations

Country	Name	City	State
Brazil	Hospital Municipal Lourenco Jorge	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
IMTN NOTES Research Group

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Zorron R, Maggioni LC, Pombo L, Oliveira AL, Carvalho GL, Filgueiras M. NOTES transvaginal cholecystectomy: preliminary clinical application. Surg Endosc. 2008 Feb;22(2):542-7. Epub 2007 Nov 20. — View Citation