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

March 21, 2016 updated by: Ayman El Nakeeb, Mansoura University

Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection of Living Donor.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Early Phase 1

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

10 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: harmonic scalpel
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.
Device: harmonic scalpel
parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler.
Other Names:
  • Group A
Active Comparator: spray mode diathermy
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.
Device: spray mode diathermy
parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler.
Other Names:
  • Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the amount of blood loss
Time Frame: 6 hours during operation
the amount of blood loss
6 hours during operation

Secondary Outcome Measures

Outcome Measure
Time Frame
operative time
Time Frame: minutes during operations
minutes during operations
number of ligation used,
Time Frame: hours during operations
hours during operations
extent of necrosis at the cut surface
Time Frame: one week postoperative
one week postoperative

Collaborators and Investigators

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

Sponsor

Mansoura University

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

Helpful Links

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

April 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hepatic transection

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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