Demonstrate the Effectiveness to Hemopatch in Controlling Postoperative Bleeding After Laparoscopic Cholecistectomy and in Reducing of Morbidity and Postoperative Hospital Stay

Efficacy of Hemopatch in Controlling of Postoperative Bleeding or Reducing of Postperative Morbidity After Laparoscopic Cholecistectomy Clinical Trial

Official title:

Efficacy of Hemopatch in Reducing of Postoperative Bleeding After Laparoscopic Cholecystectomy: Prosective and Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02777307
• Other study ID #: 474 bis/DS
• Status: Not yet recruiting
• Phase: N/A
• First received: May 17, 2016
• Last updated: May 18, 2016
• Start date: June 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2016
• Source: Ospedale Regina Apostolorum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Demonstrate the effectiveness to Hemopatch in controlling postoperative bleeding or reducing of postperative fluid collection after laparoscopic cholecistectomy, morbidity and postoperative hospital stay.

Description:

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:

• reduction of subhepatic blood liquid volume

• reduction of liver hematoma

• reduction of postooperative complications as deep surgical site

• reduction rates of reoperation

• reduction in readmission rates

• postoperative pain on the VAS scale 1-10.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Gallbladder stone

• Polyp/neoplasm of gallbladder

Exclusion Criteria:

• Coagulopathies,

• Medication with antiplatelet agents

• ASA > 3

• Acute cholecystitis

• Main biliaru duct stone

• Acute pancreatitis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Efficacy of Hemopatch in Controlling of Postoperative Bleeding or Reducing of Postperative Morbidity After Laparoscopic Cholecistectomy
• Hemorrhage
• Postoperative Hemorrhage

Intervention

Other:
• Hemopatch Sealing Hemostat
Place of Hemopatch Sealing Hemostat after laparoscopic cholecistectomy

Locations

Country	Name	City	State
Italy	Regina Apostolorum Hospital	Albano Laziale	Rome

Sponsors (4)

Lead Sponsor	Collaborator
Ospedale Regina Apostolorum	Azienda Ospedaliera San Gerardo di Monza, Ospedali Riuniti di Foggia, San Giuseppe Moscati Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Imkamp F, Tolkach Y, Wolters M, Jutzi S, Kramer M, Herrmann T. Initial experiences with the Hemopatch® 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. — View Citation

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: — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	significant reduction in postoperative hospital stay		1 year	Yes
Secondary	reducing of subhepatic volume drainage		1 year	Yes
Secondary	reducing of liver hematoma		1 year	Yes
Secondary	reducing of postoperative complications		1 year	Yes
Secondary	reducing of rates of reoperation		1 year	Yes
Secondary	reducing of re-hospitalization		1 year	Yes
Secondary	To assess postoperative pain by the VAS scale 1-10.		1 year	Yes