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Clinical Trial 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).


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02617498
Study type Interventional
Source Mansoura University
Contact
Status Completed
Phase Phase 0
Start date April 2013
Completion date November 2015

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