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Investigator decisions based on slow enrollment.
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| Name | Class |
|---|---|
| Tyco Healthcare Group LP (d/b/a Covidien) | UNKNOWN |
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This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.
Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment. Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Incision Laparoscopic Cholecsytectomy (SILS) | Active Comparator |
| |
| Traditional Laparoscopic Cholecystectomy (TLC) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-Incision Laparoscopic Surgery cholecystectomy | Procedure | Laparoscopic Cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cost associated with performance of the procedure and post-operative care until discharge | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scale reported by patient at discharge, 24 and 48 hours | 24 hours and 48 hours | |
| Amount of pain medicine required during 48 hours after surgery | 48 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly M Brown, BS, MD | St. Luke's Hospital, Kansas City, Missouri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Single-incision Laparoscopic Surgery Launched at St. Louis University Hospital. www.news-medical.net. April, 2009 | ||
| 19412642 | Background | Chamberlain RS, Sakpal SV. A comprehensive review of single-incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES) techniques for cholecystectomy. J Gastrointest Surg. 2009 Sep;13(9):1733-40. doi: 10.1007/s11605-009-0902-y. Epub 2009 May 2. | |
| 19031097 |
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| Traditional Laparoscopic Cholecystectomy (TLC) | Procedure | Laparoscopic Cholecystectomy |
|
| Major and minor gastrointestinal surgical complications, including conversion |
| 4 weeks |
| Quality of Life | 2 weeks and 4 weeks |
| Background |
| Hodgett SE, Hernandez JM, Morton CA, Ross SB, Albrink M, Rosemurgy AS. Laparoendoscopic single site (LESS) cholecystectomy. J Gastrointest Surg. 2009 Feb;13(2):188-92. doi: 10.1007/s11605-008-0735-0. Epub 2008 Nov 22. |
| ID | Term |
|---|---|
| D001657 | Biliary Dyskinesia |
| D042882 | Gallstones |
| D002764 | Cholecystitis |
| D002769 | Cholelithiasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D041761 | Cholecystolithiasis |
| D005705 | Gallbladder Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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