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

Mansoura University

Status and phase: Completed; Early Phase 1

Conditions: End Stage Liver Disease

Treatments: Device: spray mode diathermy; Device: harmonic scalpel

Study type: Interventional

Funder types: Other

Identifiers

NCT02617498

hepatic transection

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 10 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

harmonic scalpel

Active Comparator group

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.

Treatment:

Device: harmonic scalpel

spray mode diathermy

Active Comparator group

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.

Treatment:

Device: spray mode diathermy