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

January 17, 2018 updated by: Ahmad Mohammad Ahmad Sultan, Mansoura University

Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy. A Single Blinded Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al-Dakahleia
      • Mansoura, Al-Dakahleia, Egypt, 35516
        • Gastro-enterolgy surgical center, Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Liver right lobe donors

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
intraoperative
liver pathology from the cut margin
Time Frame: intraoperative
the area of necrosis will be measured in millimeters by the pathologist
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: Ahmad M Sultan, MD, Assistant prof of general surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (ESTIMATE)

August 3, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • GEC_LTx_Surg_216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatic Transplantation

Clinical Trials on Harmonic scalpel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe