Spray Diathermy Versus Harmonic Scalpel Technique for Hepatic Parenchymal Transection

Early Phase 1

Completed

• Conditions: End Stage Liver Disease
• Interventions: Device: harmonic scalpel; Device: spray mode diathermy

• Registration Number: NCT02617498
• Lead Sponsor: Mansoura University

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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2015-04
• Study Completion: 2015-11
• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-12-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-21
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
harmonic scalpel	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.
spray mode diathermy	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.

Primary Outcome Measures

Name	Time	Method
the amount of blood loss	6 hours during operation	the amount of blood loss

Secondary Outcome Measures

Name	Time	Method
operative time	minutes during operations
number of ligation used,	hours during operations
extent of necrosis at the cut surface	one week postoperative