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Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection (LDLT)

Primary Purpose

End Stage Liver Disease

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
harmonic scalpel
spray mode diathermy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Liver Disease focused on measuring living donor liver transplantation

Eligibility Criteria

10 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Consecutive patients, who were treated for end stage liver cirrhosis by LDLT

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    harmonic scalpel

    spray mode diathermy

    Arm Description

    parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler. The clearly exposed vessels were ligated by 5/0 proline or clipped according to their size.

    parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler. The clearly exposed vessels were ligated by 5/0 proline or clipped according to their size.

    Outcomes

    Primary Outcome Measures

    the amount of blood loss
    the amount of blood loss

    Secondary Outcome Measures

    operative time
    number of ligation used,
    extent of necrosis at the cut surface

    Full Information

    First Posted
    November 20, 2015
    Last Updated
    March 21, 2016
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02617498
    Brief Title
    Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection
    Acronym
    LDLT
    Official Title
    Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection of Living Donor.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in this a prospective study.Patients enrolled in the study divided into two groups according to the day of surgery. The study population was divided into two groups; group (A) Parenchymal liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver transection was performed by spray diathermy (SD).
    Detailed Description
    Consecutive patients, who were treated for end stage liver cirrhosis by LDLT were included in this a prospective study.Patients enrolled in the study divided into two groups according to the day of surgery. The study population was divided into two groups; group (A) Parenchymal liver transection was performed by harmonic scalpel (HS) and group (B) Parenchymal liver transection was performed by spray diathermy (SD). Donors and recipient were followed up after hospital discharge with laboratory investigation, abdominal ultrasound, MRCP in selected cases every month for the first month, then every 6 months and then every year postoperatively. Follow up visits included clinical examination, laboratory investigation, doses of immunosuppressive, radiological examination, and doppler US. The primary outcome was the amount of blood loss during transection. Secondary outcomes were operative time, time of transection, speed of transection/minutes , number of ligation used, degree of postoperative injury which assessed by daily liver function, WBC, C reactive protein, pathological changes at the cut surface, postoperative morbidity (including biliary leakage, collection), cost and hospital stay.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Liver Disease
    Keywords
    living donor liver transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    harmonic scalpel
    Arm Type
    Active Comparator
    Arm Description
    parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler. The clearly exposed vessels were ligated by 5/0 proline or clipped according to their size.
    Arm Title
    spray mode diathermy
    Arm Type
    Active Comparator
    Arm Description
    parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler. The clearly exposed vessels were ligated by 5/0 proline or clipped according to their size.
    Intervention Type
    Device
    Intervention Name(s)
    harmonic scalpel
    Other Intervention Name(s)
    Group A
    Intervention Description
    parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler.
    Intervention Type
    Device
    Intervention Name(s)
    spray mode diathermy
    Other Intervention Name(s)
    Group B
    Intervention Description
    parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler.
    Primary Outcome Measure Information:
    Title
    the amount of blood loss
    Description
    the amount of blood loss
    Time Frame
    6 hours during operation
    Secondary Outcome Measure Information:
    Title
    operative time
    Time Frame
    minutes during operations
    Title
    number of ligation used,
    Time Frame
    hours during operations
    Title
    extent of necrosis at the cut surface
    Time Frame
    one week postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Consecutive patients, who were treated for end stage liver cirrhosis by LDLT Exclusion Criteria: -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ayman El Nakeeb, MD
    Organizational Affiliation
    Mansoura University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22370735
    Citation
    Salah T, Sultan AM, Fathy OM, Elshobary MM, Elghawalby NA, Sultan A, Yassen AM, Elsarraf WM, Elmorshedi M, Elsaadany MF, Shiha UA, Wahab MA. Outcome of right hepatectomy for living liver donors: a single Egyptian center experience. J Gastrointest Surg. 2012 Jun;16(6):1181-8. doi: 10.1007/s11605-012-1851-4. Epub 2012 Feb 28.
    Results Reference
    result
    PubMed Identifier
    25309092
    Citation
    Wahab MA, Hamed H, Salah T, Elsarraf W, Elshobary M, Sultan AM, Shehta A, Fathy O, Ezzat H, Yassen A, Elmorshedi M, Elsaadany M, Shiha U. Problem of living liver donation in the absence of deceased liver transplantation program: Mansoura experience. World J Gastroenterol. 2014 Oct 7;20(37):13607-14. doi: 10.3748/wjg.v20.i37.13607.
    Results Reference
    result
    PubMed Identifier
    25060964
    Citation
    Sultan AM, Salah T, Elshobary MM, Fathy OM, Elghawalby AN, Yassen AM, Elmorshedy MA, Elsadany MF, Shiha UA, Wahab MA. Biliary complications in living donor right hepatectomy are affected by the method of bile duct division. Liver Transpl. 2014 Nov;20(11):1393-401. doi: 10.1002/lt.23964.
    Results Reference
    result
    PubMed Identifier
    19109835
    Citation
    El Moghazy WM, Hedaya MS, Kaido T, Egawa H, Uemoto S, Takada Y. Two different methods for donor hepatic transection: cavitron ultrasonic surgical aspirator with bipolar cautery versus cavitron ultrasonic surgical aspirator with radiofrequency coagulator-A randomized controlled trial. Liver Transpl. 2009 Jan;15(1):102-5. doi: 10.1002/lt.21658.
    Results Reference
    result
    PubMed Identifier
    18639230
    Citation
    Takatsuki M, Eguchi S, Yamanouchi K, Tokai H, Hidaka M, Soyama A, Miyazaki K, Hamasaki K, Tajima Y, Kanematsu T. Two-surgeon technique using saline-linked electric cautery and ultrasonic surgical aspirator in living donor hepatectomy: its safety and efficacy. Am J Surg. 2009 Feb;197(2):e25-7. doi: 10.1016/j.amjsurg.2008.01.019. Epub 2008 Jul 17.
    Results Reference
    result
    Links:
    URL
    http://www.mans.edu.eg/
    Description
    mansoura university

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    Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection

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