IMTN Study- International Prospective Multicenter Trial on Clinical NOTES

NCT ID: NCT00995735

Last Updated: 2009-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastrointestinal Surgery Natural Orifice Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Transgastric

Patients submitted to Transgastric NOTES surgery

Cholecystectomy

Intervention Type PROCEDURE

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

Appendectomy

Intervention Type PROCEDURE

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

Transvaginal

Patients submitted to Transvaginal surgery

Cholecystectomy

Intervention Type PROCEDURE

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

Appendectomy

Intervention Type PROCEDURE

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

Interventions

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Cholecystectomy

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

Intervention Type PROCEDURE

Appendectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients submitted to elective surgery

Exclusion Criteria

* emergency surgery High ASA risk patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IMTN NOTES Research Group

OTHER

Sponsor Role lead

Responsible Party

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Brazilian College of Surgeons CBC

Principal Investigators

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Ricardo Zorron

Role: PRINCIPAL_INVESTIGATOR

Brazilian College of Surgeons CBC

Chisunnami Palanivelu

Role: STUDY_DIRECTOR

Indian Society of Laparoscopic Surgery

Manuel Galvao

Role: STUDY_DIRECTOR

Society of Brazilian Digestive Endoscopy SOBED

Almino Ramos

Role: STUDY_DIRECTOR

Brazilian College of Surgeons CBC

Locations

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Hospital Municipal Lourenco Jorge

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Ricardo Zorron, MD, PhD

Role: CONTACT

+552191914698

Facility Contacts

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Ricardo Zorron

Role: primary

+552191914698

References

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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. doi: 10.1007/s00464-007-9646-5. Epub 2007 Nov 20.

Reference Type BACKGROUND
PMID: 18027043 (View on PubMed)

Other Identifiers

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0209.0.314.000-08

Identifier Type: -

Identifier Source: org_study_id

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