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Completed

NCT Number: NCT02617498

Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection

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).

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Key information

Conditions

End Stage Liver Disease Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure

Age range

10 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Harmonic Scalpel

Device

parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler.

Other names: Group A

spray mode diathermy

Device

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

Primary outcomes

  1. the amount of blood loss

    Time frame: 6 hours during operation

    the amount of blood loss

Secondary outcomes

  1. operative time

    Time frame: minutes during operations

  2. number of ligation used,

    Time frame: hours during operations

  3. extent of necrosis at the cut surface

    Time frame: one week postoperative

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: LDLT

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2015
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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