NCT00995735

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 15, 2009

Status Verified

October 1, 2009

Enrollment Period

2.2 years

First QC Date

October 14, 2009

Last Update Submit

October 14, 2009

Conditions

Gastrointestinal SurgeryNatural Orifice Surgery

Keywords

NOTESNatural Orifice Translumenal Endoscopic surgeryCholecystectomyAppendectomyEndoscopyLaparoscopyMinimally invasive surgeryclinical trials

Study Arms (2)

Transgastric

Patients submitted to Transgastric NOTES surgery

Procedure: CholecystectomyProcedure: Appendectomy

Transvaginal

Patients submitted to Transvaginal surgery

Procedure: CholecystectomyProcedure: Appendectomy

Interventions

CholecystectomyPROCEDURE

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

TransgastricTransvaginal
AppendectomyPROCEDURE

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

TransgastricTransvaginal

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients submitted to elective surgery

You may not qualify if:

  • emergency surgery High ASA risk patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Municipal Lourenco Jorge

Rio de Janeiro, Rio de Janeiro, 20000, Brazil

RECRUITING

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

    PMID: 18027043BACKGROUND

MeSH Terms

Interventions

CholecystectomyAppendectomy

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ricardo Zorron

    Brazilian College of Surgeons CBC

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

Central Study Contacts

Ricardo Zorron, MD, PhD

CONTACT

+552191914698rzorron@terra.com.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 15, 2009

Study Start

June 1, 2007

Primary Completion

August 1, 2009

Study Completion

December 1, 2009

Last Updated

October 15, 2009

Record last verified: 2009-10

Locations

BR(1)