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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 31, 2007 | ||||
| Last Updated Date | May 12, 2008 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES [ Time Frame: continuous ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES [ Time Frame: continuous ] | ||||
| Change History | Complete list of historical versions of study NCT00552162 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH [ Time Frame: continuous ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH [ Time Frame: continuous ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | NOTES Transvaginal Cholecystectomy and Appendectomy | ||||
| Official Title ICMJE | NOTES Transvaginal Cholecystectomy and Appendectomy | ||||
| Brief Summary | Natural Orifice Translumenal Endoscopic Surgery (NOTES) is considered by many leading expert surgeons to be the next step in MIS (Minimally Invasive Surgery). This is a rapidly evolving area of preclinical research and several groups worldwide are developing this surgical approach together with industry support. In this new surgical technique, abdominal operations are performed using the oropharynx, rectum, or vagina as the ports of entry to the peritoneal cavity instead of incisions on the abdominal wall. NOTES offers all the advantages of minimally invasive surgery (MIS) and also completely eliminates trauma to the abdominal wall and the numerous complications of abdominal wall incisions. A NOTES procedure eliminates any visible scar and could also potentially reduce post operative pain due to the elimination of abdominal wall trauma. In this trial we intend to operate healthy women who need to undergo cholecystectomy or appendectomy. The operations will be performed through the vagina as the access port to the peritoneum and it will be monitored with laparoscopic vision for safety reasons. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | July 2009 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria for group #1 Transvaginal cholecystectomy:
Exclusion Criteria for group #1 Transvaginal cholecystectomy:
Inclusion Criteria for group #2 Transvaginal appendectomy:
Exclusion Criteria for group #2 Transvaginal appendectomy:
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| Gender | Female | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00552162 | ||||
| Responsible Party | Yoav Mintz MD, Hadassah Medical Organization | ||||
| Study ID Numbers ICMJE | NOTES HMO-CTIL, 21-2.11.07 | ||||
| Study Sponsor ICMJE | Hadassah Medical Organization | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hadassah Medical Organization | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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