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Sponsored by: |
University of California, San Diego |
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Information provided by: | University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT00530998 |
A research study to find out more about an investigational approach to perform surgery that has not been done in humans before at this institution. Normally this type of surgery would be done laparoscopically or open. Laparoscopic surgery is where the doctor would make several (3-6) small opening in the abdomen; places a camera and other instruments and removes the gallbladder through a small incision in the lower right abdomen. Open surgery is where the doctor makes approximately a 6 inch incision into the abdomen and removes the gallbladder. This investigational procedure is called Natural Orifice Translumenal Endoscopic Surgery (NOTES). This means that surgery would be done through the mouth, vagina or rectum. In this study, the doctor will perform this investigational method of surgery through the vagina.
Condition | Intervention |
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Appendicitis Cholelithiasis Gallstones |
Procedure: Transvaginal Appendectomy Procedure: Transvaginal Cholecystectomy |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Appendectomy and Cholecystectomy |
Estimated Enrollment: | 30 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | September 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Group #1 NOTES Appendectomy - Transvaginal approach
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Procedure: Transvaginal Appendectomy
The appendix will be removed via an incision in the vagina.
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2: Active Comparator
Group #2 NOTES Cholecystectomy - Transvaginal approach
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Procedure: Transvaginal Cholecystectomy
The gallbladder will be removed via an incision in the vagina.
|
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion criteria for transvaginal appendectomy:
Exclusion criteria for transvaginal appendectomy:
Group #2 NOTES Cholecystectomy - Transvaginal approach:
Inclusion criteria for transvaginal cholecystectomy:
Exclusion criteria for transvaginal cholecystectomy:
Contact: Julie A Bosia, BSN | 619-471-0447 | misresearch@ucsd.edu |
United States, California | |
University of California, San Diego | Recruiting |
San Diego, California, United States, 92103 | |
Principal Investigator: Santiago Horgan, MD |
Principal Investigator: | Santiago Horgan, MD | University of California, San Diego |
Study Chair: | Mark A Talamini, MD | University of California, San Diego |
Responsible Party: | University of California, San Diego ( Santiago Horgan, MD ) |
Study ID Numbers: | 071115 |
Study First Received: | September 17, 2007 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00530998 |
Health Authority: | United States: Institutional Review Board |
appendicitis cholelithiasis Gallstones |
Pathological Conditions, Anatomical Gallbladder Diseases Cholecystolithiasis Digestive System Diseases Cholelithiasis Gastrointestinal Diseases |
Gallstones Biliary Tract Diseases Appendicitis Calculi Intestinal Diseases Gastroenteritis |
Cecal Diseases |