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| Name | Class |
|---|---|
| Azienda Ospedaliera San Gerardo di Monza | OTHER |
| San Giuseppe Moscati Hospital | OTHER |
| Ospedali Riuniti di Foggia | OTHER |
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Demonstrate the effectiveness to Hemopatch in controlling postoperative bleeding or reducing of postperative fluid collection after laparoscopic cholecistectomy, morbidity and postoperative hospital stay.
Prospective Multicenter Longitudinal and cohort. The sample size of 150 patients was calculated in order to obtain a statistical power adequacy or higher (Type I error - Alpha = 0.05, Type II Error - Beta = 0:20), assuming the 1-day to reduce the postoperative stay with use Hemopatch compared to the control (average stay little 3 +/- 2 days).
Primary endpoint:
- significant reduction in postoperative hospital stay
Secondary endpoints:
The results obtained in relation to primary and secondary objectives will be compared with a control group of case-matched.
Inclusion Criteria:
- Between the ages of 18-75 years, calculus of gallbladder (micro- and macro-lithiasis), polyp/neoplasm of gallbladder
Exclusion Criteria:
- Coagulopathies, medication with antiplatelet drugs, ASA > 3, acute cholecystitis, simultaneous calculus of main biliary duct, acute pancreatitis.
The patient will enroll if cholecystectomy is performed laparoscopically, if it is not a complication occurred intraoperative type: iatrogenic enterotomy suture intestinal, iatrogenic lesion of liver parenchyma, bile duct injury. The patient will exclude from the study if one of these intraoperative complication will occur. The patient leaves the protocol if the dissection is done through energy-devices (ultrasound or radiofrequency).
At the end of the laparoscopic cholecstectomy, Hemopatch will be inserted into the peritoneal cavity through the port of 10-12 mm and laid on the cavity of the gallbladder and a drainage will be systematically placed.
It will be given a first-generation cephalosporin antibiotic (one shot).
At 24 hours of VLC a liver ultrasound will be performed and recorded: evaluation of presence of perihepatic fluid, collection or haematoma. It will be noted the volume of drainage which will be removed in first postoperative day. In case of delay removal of drainage, it will be recorded. It will be assessed postoperative pain by VAS scales to 6-12-24 h after surgery. Re-operations and re-hospitalizations will be recorded in prospective data.
Statistical analyzes were performed using the software SPSS for Mac, 22nd edition (SPSS Software, Inc., IL, Chicago). The differences in the distributions will be calculated using the chi-square test or Fisher exact test, depending on the number of cases in the various subgroups and by comparing means (Student t-test, one-way ANOVA test).
The p < 0.1 will be used as the cut-off for statistical significance in the selection of variables of multivariate analysis in order not to drop important potential predictors.
The statistical significance is conventionally defined with p <0.05 in all cases considered.
All eligible patients will be adequately informed and informed consent will be signed. The Study will be conducted according to ethical requirements, following the Declaration of Helsinki, and good clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemopatch Sealing Hemostat | Experimental |
| |
| No Hemopatch Sealing Hemostat | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemopatch Sealing Hemostat | Other | Place of Hemopatch Sealing Hemostat after laparoscopic cholecistectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| significant reduction in postoperative hospital stay | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| reducing of subhepatic volume drainage | 1 year | |
| reducing of liver hematoma | 1 year | |
| reducing of postoperative complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regina Apostolorum Hospital | Albano Laziale | Rome | 00041 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24729905 | Result | Lewis KM, McKee J, Schiviz A, Bauer A, Wolfsegger M, Goppelt A. Randomized, controlled comparison of advanced hemostatic pads in hepatic surgical models. ISRN Surg. 2014 Mar 4;2014:930803. doi: 10.1155/2014/930803. eCollection 2014. | |
| 25085811 | Result | Lewis KM, Spazierer D, Slezak P, Baumgartner B, Regenbogen J, Gulle H. Swelling, sealing, and hemostatic ability of a novel biomaterial: A polyethylene glycol-coated collagen pad. J Biomater Appl. 2014 Nov;29(5):780-8. doi: 10.1177/0885328214545500. Epub 2014 Aug 1. |
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| 1 year |
| reducing of rates of reoperation | 1 year |
| reducing of re-hospitalization | 1 year |
| To assess postoperative pain by the VAS scale 1-10. | 1 year |
| 25239500 | Result | Imkamp F, Tolkach Y, Wolters M, Jutzi S, Kramer M, Herrmann T. Initial experiences with the Hemopatch(R) as a hemostatic agent in zero-ischemia partial nephrectomy. World J Urol. 2015 Oct;33(10):1527-34. doi: 10.1007/s00345-014-1404-4. Epub 2014 Sep 20. |
| 25106082 | Result | Lewis KM, Schiviz A, Hedrich HC, Regenbogen J, Goppelt A. Hemostatic efficacy of a novel, PEG-coated collagen pad in clinically relevant animal models. Int J Surg. 2014;12(9):940-4. doi: 10.1016/j.ijsu.2014.07.017. Epub 2014 Aug 6. |
| 21627788 | Result | Stokes ME, Ye X, Shah M, Mercaldi K, Reynolds MW, Rupnow MF, Hammond J. Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients. BMC Health Serv Res. 2011 May 31;11:135. doi: 10.1186/1472-6963-11-135. |
| 20004553 | Result | Keus F, Wetterslev J, Gluud C, Gooszen HG, van Laarhoven CJ. Trial sequential analyses of meta-analyses of complications in laparoscopic vs. small-incision cholecystectomy: more randomized patients are needed. J Clin Epidemiol. 2010 Mar;63(3):246-56. doi: 10.1016/j.jclinepi.2009.08.023. Epub 2009 Dec 11. |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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