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临床试验/NCT02617498
NCT02617498已完成早期 1 期

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

Mansoura University0 个研究点目标入组 80 人开始时间: 2013年4月最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
80
主要终点
the amount of blood loss

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
10 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

harmonic scalpel

Active Comparator

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.

干预措施: harmonic scalpel (Device)

spray mode diathermy

Active Comparator

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.

干预措施: spray mode diathermy (Device)

结局指标

主要结局

the amount of blood loss

时间窗: 6 hours during operation

the amount of blood loss

次要结局

  • number of ligation used,(hours during operations)
  • operative time(minutes during operations)
  • extent of necrosis at the cut surface(one week postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman El Nakeeb

principal investigator

Mansoura University

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