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| Sponsors and Collaborators: |
Universidad Juarez Durango Hospital Universitario La Paz |
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| Information provided by: | North Texas Veterans' Healthcare System |
| ClinicalTrials.gov Identifier: | NCT00710502 |
Purpose
Cholecystectomy is one of the most common general surgery procedures performed in the US today and is among top 10 procedures performed in U.S. hospitals annually, and biliary tract disease has been estimated to cost U.S. healthcare $5 billion/year. Laparoscopic cholecystectomy was introduced in the early 1990s and has become the standard surgical approach for the treatment of gallbladder disease. More than 500,000 cholecystectomy procedures are performed in the US every year. Laparoscopic cholecystectomy is now performed as an outpatient basis and is related to a very low complication rate. Laparoscopic cholecystectomy requires the use of multiple trocar incisions.
Natural Orifice Translumenal Endoscopic Surgery(NOTES) is a new type of surgical procedure currently being studied around the world. The idea of NOTES was developed several years ago in response to the concepts that patients would
All of these advantages have spurred research and investigation forward, encouraging physicians and researchers to develop new equipment and techniques to use during NOTES procedures. Although the Natural Orifice Translumenal Endoscopic Surgery approach may hold tremendous potential, there are many issues that need to be addressed before this technique is introduced into clinical care.
The purpose of this study is to determine the safety, feasibility and short-term clinical outcomes (Phase I trial) of transvaginal NOTES cholecystectomy in female patients with symptomatic cholelithiasis and compare it to Laparoscopic Cholecystectomy (Phase II).
Hypothesis 1: Transvaginal NOTES cholecystectomy is safe and feasible in female patients with symptomatic cholelithiasis.
Hypothesis 2: The short term outcomes of Transvaginal NOTES cholecystectomy are comparable to Laparoscopic Cholecystectomy in female patients with symptomatic cholelithiasis.
Aim 1: Determine the safety of Transvaginal NOTES cholecystectomy. Aim 2: Determine the feasibility of Transvaginal NOTES cholecystectomy. Aim 3: Determine the short-term outcomes of Transvaginal NOTES cholecystectomy. Aim 4: Compare the short-term outcomes of Transvaginal NOTES cholecystectomy to Laparoscopic cholecystectomy.
| Condition | Intervention | Phase |
|---|---|---|
|
Cholelithiasis |
Procedure: Transvaginal NOTES cholecystectomy Procedure: Laparoscopic cholecystectomy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Transvaginal Natural Orifice Translumenal and Endoscopic Surgery (NOTES) Cholecystectomy vs. Laparoscopic Cholecystectomy: Phase I/II Clinical Trial |
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Transvaginal NOTES Cholecystectomy (Phase 1)
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Procedure: Transvaginal NOTES cholecystectomy
Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
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2: Active Comparator
Laparoscopic Cholecystectomy (Phase 2)
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Procedure: Laparoscopic cholecystectomy
Under general anesthesia, patients will undergo standard Laparoscopic cholecystectomy
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3: Experimental
Transvaginal NOTES cholecystectomy (Phase 2)
|
Procedure: Transvaginal NOTES cholecystectomy
Under general anesthesia, patients will undergo Transvaginal NOTES cholecystectomy
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Most recently, surgeons and endoscopists have focused on NOTES cholecystectomy. Access to the abdominal cavity to perform NOTES procedures has been obtained by transgastric, transvaginal, transvesical and transrectal approaches. The first successful NOTES procedure in humans was an appendectomy in India. Transvaginal NOTES cholecystectomy has been successfully performed and reported in a handful of cases in the US, Europe and South America. However, to date, there is lack of clinical trials that demonstrate the safety and feasibility of Transvaginal NOTES cholecystectomy in a larger group of patients.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Mexico | |
| Universidad Juarez del Estado de Durango, Mexico | |
| Durango, Mexico, 34000 | |
| Principal Investigator: | Homero Rivas, MD | Hospital de la Paz |
| Principal Investigator: | Esteban Varela, MD, MPH | Hospital de la Paz |
More Information
| Responsible Party: | Hospital de la Paz ( Homero Rivas MD and Esteban Varela MD, MPH ) |
| Study ID Numbers: | 05626 |
| Study First Received: | July 2, 2008 |
| Last Updated: | September 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00710502 |
| Health Authority: | Mexico: Ethics Committee; United States: Federal Government |
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Transvaginal NOTES Cholecystectomy Laparoscopic |
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Pathological Conditions, Anatomical Gallbladder Diseases Cholecystolithiasis Digestive System Diseases |
Cholelithiasis Gallstones Biliary Tract Diseases Calculi |
