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Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy (KK_HS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853981
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmad Mohammad Ahmad Sultan, Mansoura University

Brief Summary:
The purpose of this study is to determine whether clamp-crush technique for liver parenchymal transection is as safe as Harmonic scalpel device. outcomes will include: perioperative mortality, surgery-related complications, blood loss, amount of blood loss during hepatectomy, operating time, transection speed, markers of liver parenchymal injury and hospital stay.

Condition or disease Intervention/treatment Phase
Hepatic Transplantation Device: Harmonic scalpel Device: Kelly clamp crush technique Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy. A Single Blinded Randomized Controlled Trial
Actual Study Start Date : January 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Active Comparator: Harmonic scalpel group
group of donors whom will undergo liver transection using harmonic scalpel.
Device: Harmonic scalpel
a method for liver parenchymal transection

Active Comparator: clamp-crush group
group of donors whom will undergo liver transection using Kelly clamp.
Device: Kelly clamp crush technique
a method for liver parenchymal transection




Primary Outcome Measures :
  1. blood loss during hepatectomy [ Time Frame: intraoperative ]
    bleeding during transection phase will be calculated in mL. based on the blood in the sucker machine and the surgical towels


Secondary Outcome Measures :
  1. transection speed [ Time Frame: intraoperative ]
    the transection speed will be calculated in minutes based on the relation between the transecition time divided by the surface area of the raw area of the graft measured on the backtable.

  2. liver pathology from the cut margin [ Time Frame: intraoperative ]
    the area of necrosis will be measured in millimeters by the pathologist



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Liver right lobe donors

Exclusion Criteria:

-


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): NCT02853981


Locations
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Egypt
Gastro-enterolgy surgical center, Mansoura University
Mansoura, Al-Dakahleia, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Investigators
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Study Director: Ahmad M Sultan, MD Assistant prof of general surgery
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahmad Mohammad Ahmad Sultan, Assistant professor of general surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT02853981    
Other Study ID Numbers: GEC_LTx_Surg_216
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided