Gastrointestinal SurgeryIMTNNCT00995735
IMTN Study- International Prospective Multicenter Trial on Clinical NOTES
An observational study of Gastrointestinal Surgery and Natural Orifice Surgery, run by IMTN NOTES Research Group at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Surgery, Natural Orifice Surgery
- What is being tested?
- Cholecystectomy and Appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2007to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients submitted to Natural Orifice Surgery with local IRB aproval for human trials.
Who may be able to join
- Patients submitted to elective surgery
Who cannot join
- emergency surgery High ASA risk patients
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Municipal Lourenco Jorge
Rio de Janeiro, Rio de Janeiro, 20000
Ricardo Zorron, +552191914698
Ricardo Zorron, MD, PhD
About this study
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.
- Conditions
- Gastrointestinal Surgery, Natural Orifice Surgery
- Being tested
- Cholecystectomy, Appendectomy
- Keywords
- NOTES, Natural Orifice Translumenal Endoscopic surgery, Cholecystectomy, Appendectomy, Endoscopy, Laparoscopy, Minimally invasive surgery, clinical trials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Cholecystectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.
AppendectomyProcedure or surgery
Appendectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening.
| Study group | Role | What they receive |
|---|---|---|
| Transgastric | Patients submitted to Transgastric NOTES surgery Receives: Procedure: Cholecystectomy; Procedure: Appendectomy | |
| Transvaginal | Patients submitted to Transvaginal surgery Receives: Procedure: Cholecystectomy; Procedure: Appendectomy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startJun 2007
- Primary completionAug 2009
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IMTN NOTES Research Group
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo Zorron, Principal investigator, Brazilian College of Surgeons CBCChisunnami Palanivelu, Study director, Indian Society of Laparoscopic SurgeryManuel Galvao, Study director, Society of Brazilian Digestive Endoscopy SOBEDAlmino Ramos, Study director, Brazilian College of Surgeons CBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995735
- Sponsor's protocol ID
- 0209.0.314.000-08
- Acronym
- IMTN
- Status last verified
- Oct 2009
- First submitted
- 14 Oct 2009
- Last updated
- 15 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18027043
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMTN Study- International Prospective Multicenter Trial on Clinical NOTES
- ClinicalTrials.gov ID
- NCT00995735
- Acronym / sponsor ID
- IMTN / 0209.0.314.000-08
- Conditions
- Gastrointestinal Surgery, Natural Orifice Surgery
- Keywords
- NOTES, Natural Orifice Translumenal Endoscopic surgery, Cholecystectomy, Appendectomy, Endoscopy, Laparoscopy, Minimally invasive surgery, clinical trials
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- IMTN NOTES Research GroupUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 15 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgastric | – | Procedure: Cholecystectomy, Procedure: AppendectomyPatients submitted to Transgastric NOTES surgery |
| Transvaginal | – | Procedure: Cholecystectomy, Procedure: AppendectomyPatients submitted to Transvaginal surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted to Natural Orifice Surgery with local IRB aproval for human trials.
Key inclusion criteria (1 listed)
- Patients submitted to elective surgery
Key exclusion criteria (1 listed)
- emergency surgery High ASA risk patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecystectomyCholecystectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening. | Procedure or surgery | Transgastric, Transvaginal |
| AppendectomyAppendectomy performed either by entering the stomach wall with the endoscope, or through a posterior vaginal opening. | Procedure or surgery | Transgastric, Transvaginal |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2009.
- Background: PubMed 18027043Zorron 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.
Related trials for Gastrointestinal Surgery
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
Enrolling by invitationObservational study
Intestinal Obstruction Surgery. Acute Abdominal Pathology. №9:05/05/2026
Small Bowel Adhesion, Obstruction Bowel
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis
Gastric Cancer, Gastric Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Zorron principal investigator
Brazilian College of Surgeons CBC
Chisunnami Palanivelu study director
Indian Society of Laparoscopic Surgery
Manuel Galvao study director
Society of Brazilian Digestive Endoscopy SOBED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Surgery and Natural Orifice Surgery, run by IMTN NOTES Research Group at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Zorron, MD, PhD (+552191914698, rzorron@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00995735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2009.