Clinical trial NCT02777307: Demonstrate the Effectiveness to Hemopatch in Controlling Postoperative Bleeding After Laparoscopic Cholecistectomy and in Reducing of Morbidity and Postoperative Hospital Stay
Official title: Efficacy of Hemopatch in Reducing of Postoperative Bleeding After Laparoscopic Cholecystectomy: Prosective and Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Efficacy of Hemopatch in Controlling of Postoperative Bleeding or Reducing of Postperative Morbidity After Laparoscopic Cholecistectomy
Keywords: Laparoscopic
Cholecistectomy
Collection
Bleeding
reoperation
Lead sponsor: Ospedale Regina Apostolorum
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera San Gerardo di Monza
name: San Giuseppe Moscati Hospital
name: Ospedali Riuniti di Foggia
First posted: 2016-05-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: significant reduction in postoperative hospital stay
timeFrame: 1 year
Secondary outcomes:
measure: reducing of subhepatic volume drainage
timeFrame: 1 year
measure: reducing of liver hematoma
timeFrame: 1 year
measure: reducing of postoperative complications
timeFrame: 1 year
measure: reducing of rates of reoperation
timeFrame: 1 year
measure: reducing of re-hospitalization
timeFrame: 1 year
measure: To assess postoperative pain by the VAS scale 1-10.
timeFrame: 1 year
Other outcomes:
Locations:
city: Albano Laziale
country: Italy
facility: Regina Apostolorum Hospital
state: Rome
Study officials:
References:
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.
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 2014 Aug 1.
citation: 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.
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.
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: 10.1186/1472-6963-11-135.
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: 10.1016/j.jclinepi.2009.08.023. Epub 2009 Dec 11.