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Stapler vs. LigaSure in Elective Hepatic Resection (CRUNSHII)

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ClinicalTrials.gov Identifier: NCT01858987
Recruitment Status : Completed
First Posted : May 21, 2013
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Nuh Rahbari, Heidelberg University

Brief Summary:
The optimal technique of parenchymal transection in liver surgery has remained a matter of controversial debate among hepatobiliary surgeons. The optimal technique should enable secure sealing of the vascular and biliary structures that results in low intraoperative blood loss as well as low postoperative complication rates. Although numerous devices have been introduced and are used widely, high-level evidence, randomized controlled trials, that evaluate efficacy and safety of these devices are scarce. In the present randomized controlled trial two techniques of hepatic resection using vascular staplers and the LigaSure vessel sealing device are compared. While the primary endpoint is intraoperative blood loss a set of general and surgical variables will be analyzed to evaluate efficacy and safety of both methods.

Condition or disease Intervention/treatment Phase
Liver Resection Procedure: Stapler hepatectomy Procedure: LigaSure hepatectomy Device: Ligasure Other: vascular staple Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stapler vs. LigaSure for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH II - A Randomized Controlled Trial
Actual Study Start Date : November 2, 2011
Actual Primary Completion Date : July 17, 2014
Actual Study Completion Date : August 14, 2014

Arm Intervention/treatment
Active Comparator: Stapler hepatectomy
Liver resection using vascular stapler for transection of the parenchyma
Procedure: Stapler hepatectomy
Liver resection using vascular stapler for transection of the parenchyma

Other: vascular staple
Experimental: LigaSure Hepatectomy
Liver resection using LigaSure for transection of the parenchyma
Procedure: LigaSure hepatectomy
Liver resection using LigaSure for transection of the parenchyma

Device: Ligasure



Primary Outcome Measures :
  1. Intraoperative Blood loss [ Time Frame: Beginning to end of surgical procedure ]
    Intraoperative blood loss represents the primary efficacy endpoint of the CRUNSH II-Trial. To obtain a more precise estimate for the individual patient patient's individual transection area will be considered as a continuous covariate in the analysis of covariance (ANOVA). The transection area will be assessed using an imprint of the resected specimen on a paper sheet with a known density of 80 mg/m2. The marked paper area will be cut and weight to calculate the transection area. Intraoperative blood loss will be measured according to the blood collected in the suction containers. Spilling water and ascites will be subtracted. Furthermore, swabs will be squeezed and their content will also be sucked and added to the fluid collected in the suction containers. Central venous pressure will be lowered below 5 cmH2O for the transection period.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for elective hepatic resection
  • Parenchymal transection by vascular stapler and LigaSure feasible
  • Age equal or greater than 18 years
  • Informed consent

Exclusion Criteria:

  • Extrahepatic resection required based on preoperative imaging
  • Participation in concurrent surgical intervention trials
  • Expected lack of compliance
  • Impaired mental state or language problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858987


Locations
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Germany
UniversityHospital Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Heidelberg University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nuh Rahbari, MD, Heidelberg University
ClinicalTrials.gov Identifier: NCT01858987    
Other Study ID Numbers: NNR-08
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017