NCT02777307

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

May 17, 2016

Last Update Submit

May 18, 2016

Conditions

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

Keywords

LaparoscopicCholecistectomyCollectionBleedingreoperation

Outcome Measures

Primary Outcomes (1)

  • significant reduction in postoperative hospital stay

    1 year

Secondary Outcomes (6)

  • reducing of subhepatic volume drainage

    1 year

  • reducing of liver hematoma

    1 year

  • reducing of postoperative complications

    1 year

  • reducing of rates of reoperation

    1 year

  • reducing of re-hospitalization

    1 year

  • +1 more secondary outcomes

Study Arms (2)

Hemopatch Sealing Hemostat

EXPERIMENTAL
Other: Hemopatch Sealing Hemostat

No Hemopatch Sealing Hemostat

NO INTERVENTION

Interventions

Hemopatch Sealing HemostatOTHER

Place of Hemopatch Sealing Hemostat after laparoscopic cholecistectomy

Hemopatch Sealing Hemostat

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gallbladder stone
  • Polyp/neoplasm of gallbladder

You may not qualify if:

  • Coagulopathies,
  • Medication with antiplatelet agents
  • ASA \> 3
  • Acute cholecystitis
  • Main biliaru duct stone
  • Acute pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina Apostolorum Hospital

Albano Laziale, Rome, 00041, Italy

Location

Related Publications (6)

  • 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.

    PMID: 24729905RESULT

  • 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.

    PMID: 25085811RESULT

  • 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.

    PMID: 25239500RESULT

  • 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.

    PMID: 25106082RESULT

  • 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.

    PMID: 21627788RESULT

  • 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.

    PMID: 20004553RESULT

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of surgery department

Study Record Dates

First Submitted

May 17, 2016

First Posted

May 19, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

May 1, 2017

Last Updated

May 19, 2016

Record last verified: 2016-05

Locations

IT(1)