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IMTN Study- International Prospective Multicenter Trial on Clinical NOTES

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by IMTN NOTES Research Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
IMTN NOTES Research Group
ClinicalTrials.gov Identifier:
NCT00995735
First received: October 14, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Gastrointestinal Surgery
Natural Orifice Surgery
 Procedure: Cholecystectomy
Procedure: Appendectomy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: IMTN Study- International Prospective Multicenter Trial on Clinical NOTES

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by IMTN NOTES Research Group:

Estimated Enrollment: 1000
Study Start Date: June 2007
Estimated Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Transgastric
Patients submitted to Transgastric NOTES surgery
 Procedure: Cholecystectomy
Cholecystectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.
Procedure: Appendectomy
Appendectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.
Transvaginal
Patients submitted to Transvaginal surgery
 Procedure: Cholecystectomy
Cholecystectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.
Procedure: Appendectomy
Appendectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients submitted to Natural Orifice Surgery with local IRB aproval for human trials.

Criteria

Inclusion Criteria:

  • Patients submitted to elective surgery

Exclusion Criteria:

  • emergency surgery High ASA risk patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995735

Contacts
Contact: Ricardo Zorron, MD, PhD +552191914698 rzorron@terra.com.br

Locations
Brazil
Hospital Municipal Lourenco Jorge Recruiting
Rio de Janeiro, RJ, Brazil, 20000
Contact: Ricardo Zorron     +552191914698        
Principal Investigator: Ricardo Zorron, MD, PhD            
Sponsors and Collaborators
IMTN NOTES Research Group
Investigators
Principal Investigator: Ricardo Zorron Brazilian College of Surgeons CBC
Study Director: Chisunnami Palanivelu Indian Society of Laparoscopic Surgery
Study Director: Manuel Galvao Society of Brazilian Digestive Endoscopy SOBED
Study Director: Almino Ramos Brazilian College of Surgeons CBC
  More Information

Publications:

Responsible Party: Ricardo Zorron, Professor and Chairman, MD, PhD, Brazilian College of Surgeons CBC
ClinicalTrials.gov Identifier: NCT00995735     History of Changes
Other Study ID Numbers: 0209.0.314.000-08
Study First Received: October 14, 2009
Last Updated: October 14, 2009
Health Authority: Brazil: Ministry of Health

Keywords provided by IMTN NOTES Research Group:
NOTES
Natural Orifice Translumenal Endoscopic surgery
Cholecystectomy
Appendectomy
 Endoscopy
Laparoscopy
Minimally invasive surgery
clinical trials

ClinicalTrials.gov processed this record on May 19, 2013