IMTN Study- International Prospective Multicenter Trial on Clinical NOTES (IMTN)

October 14, 2009 updated by: IMTN NOTES Research Group
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20000
        • Recruiting
        • Hospital Municipal Lourenco Jorge
        • Contact:
          • Ricardo Zorron
          • Phone Number: +552191914698
        • Principal Investigator:
          • Ricardo Zorron, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients submitted to elective surgery

Exclusion Criteria:

  • emergency surgery High ASA risk patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

October 14, 2009

First Submitted That Met QC Criteria

October 14, 2009

First Posted (Estimate)

October 15, 2009

Study Record Updates

Last Update Posted (Estimate)

October 15, 2009

Last Update Submitted That Met QC Criteria

October 14, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0209.0.314.000-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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