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| Sponsored by: |
USGI Medical |
| Information provided by: | USGI Medical |
| ClinicalTrials.gov Identifier: | NCT00486655 |
Purpose
This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.
| Condition | Intervention |
|
Cholelithiasis Cholecystitis |
Procedure: NOTES-Assisted Cholecystectomy |
| MedlinePlus related topics: | Gallstones |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Estimated Enrollment: | 25 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | June 2007 |
A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites.
A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.
Eligibility
| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Oregon | |||||
| Oregon Clinic | Recruiting | ||||
| Portland, Oregon, United States, 97210 | |||||
| Contact: Lisa Leeth 503-963-2872 lleeth@orclinic.com | |||||
| USGI Medical |
| Principal Investigator: | Lee Swanstrom, MD | Oregon Clinic |
More Information
| Study ID Numbers: | LS0701 |
| First Received: | June 12, 2007 |
| Last Updated: | June 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00486655 |
| Health Authority: | United States: Institutional Review Board |
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