NOTES Transvaginal Cholecystectomy and Appendectomy
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|ClinicalTrials.gov Identifier: NCT00552162|
Recruitment Status : Recruiting
First Posted : November 1, 2007
Last Update Posted : April 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Gallbladder Diseases Appendicitis||Procedure: NOTES Transvaginal Cholecystectomy Procedure: NOTES Transvaginal Appendectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NOTES Transvaginal Cholecystectomy and Appendectomy|
|Study Start Date :||June 2008|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||July 2020|
Active Comparator: 1
NOTES Transvaginal cholecystectomy The gallbladder will be dissected free and will be removed through an incision in the vagina.
Procedure: NOTES Transvaginal Cholecystectomy
The gallbladder will be dissected free and will be removed through an incision in the vagina.
Active Comparator: 2
NOTES Transvaginal Appendectomy. The appendix will be dissected free and will be removed through an incision in the vagina.
Procedure: NOTES Transvaginal Appendectomy
The appendix will be dissected free and will be removed through an incision in the vagina.
- TO ASSESS THE SAFETY AND EFFICACY OF A NOVEL APPROACH TO MINIMALLY INVASIVE SURGICAL TECHNIQUES [ Time Frame: continuous ]
- TO ASSESS PAIN ASSOCIATED WITH TRANSVAGINAL APPROACH [ Time Frame: continuous ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00552162
|Contact: Yoav Mintz, MDemail@example.com|
|Hadassah Medical Center||Recruiting|
|Jerusalem, Israel, 12000|
|Contact: Ronit Ungar +972-26779694 firstname.lastname@example.org|
|Principal Investigator: Yoav Mintz, Associate Professor of Surgery|
|Hadassah Medical Organization||Active, not recruiting|
|Principal Investigator:||Yoav Mintz, MD||Hadassah Medical Organization|