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Acute cholecystitis is the most common complication of cholelithiasis. Acute cholecystitis is inflammation of the gallbladder that develops over hours, usually due to an obstruction of the cystic duct by a gallstone. Removal of the gallbladder (Cholecystectomy) is the only definitive treatment for acute cholecystitis, with laparoscopic cholecystectomy (LC) considered the gold standard. Serious complications that may occur with laparoscopic cholecystectomy, including bile duct injury, bile leaks, bleeding, and bowel injury, result in part from the anatomy, disease related pathology and structural misidentification due to inflammatory process (Gupta 2019).
The CADISSĀ® System, Chemically Assisted mechanical DISSection, is intended for the selective detachment of pathological tissue layers and/or fibrotic tissues in various surgical procedures without using cutting instruments. It is based on the property of the drug mesna (Sodium 2-mercaptoethane sulfonate) to cleave the disulfide bonds responsible for the adherence of pathological tissues and for the strength of fibrosis. This study is a prospective, multi-sites, open label, single cohort clinical trial evaluating the use of CADISSĀ® system to facilitate dissection of severe adhesions in cholecystectomy and to allow better identification of different structure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CADISSĀ® System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CADISSĀ® System | Combination Product | The CADISSĀ® device was procured from AuXin Surgery. It consists in three elements:
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability of the CADISSĀ® System to dissect adherences without cutting | Percentage of successful dissection | Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The facilitation of detachment with the CADISS System | Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice | Surgery |
| The change of bleeding with the use of the CADISS System |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alphonse Lubansu | University Hospital Erasme, Brussels, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AuXin Surgery | Louvain-la-Neuve | 1348 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36319896 | Derived | Malvaux P, Gherardi D, Gryspeerdt F, De Gheldere C. The utility of the CADISS(R) system in laparoscopic cholecystectomy for acute cholecystitis. Surg Endosc. 2022 Dec;36(12):9462-9468. doi: 10.1007/s00464-022-09616-w. Epub 2022 Nov 1. |
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| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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|
Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice. A score above 5 means the use of CADISS System reduction reduce bleeding compared to the current practice. |
| Surgery |
| A change of surgical complication risk | Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice. A score above 5 means the use of the CADISS System reduce the risk of surgical complication risks compared to the current practice. | Surgery |
| The capability of the CADISS System to highlight the cleavage plane | Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice. A score above 5 means an improvement compared to the current practice | Surgery |
| The ease of use of the CADISS System | Likert scale - 0 to 10, A score of 0 representing the worse outcome | Surgery |
| The easiness of control of the topical application with the CADISS System | Likert scale - 0 to 10, A score of 0 representing the worse outcome | Surgery |
| Adverse events | All CADISSĀ® related adverse events will be reported | Surgery, 2 to 5 days after surgery (Hospital discharge), 6 weeks follow-up |