Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy

Hepatic Transplantation Clinical Trial

— KK_HS  

Official title:

Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy. A Single Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853981
• Other study ID #: GEC_LTx_Surg_216
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 11, 2016
• Last updated: January 17, 2018
• Start date: January 2015
• Est. completion date: September 2016

Study information

• Verified date: January 2018
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether clamp-crush technique for liver parenchymal transection is as safe as Harmonic scalpel device. outcomes will include: perioperative mortality, surgery-related complications, blood loss, amount of blood loss during hepatectomy, operating time, transection speed, markers of liver parenchymal injury and hospital stay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Liver right lobe donors

Exclusion Criteria:

Related Conditions & MeSH terms

• Hepatic Transplantation

Intervention

Device:
• Harmonic scalpel
a method for liver parenchymal transection
• Kelly clamp crush technique
a method for liver parenchymal transection

Locations

Country	Name	City	State
Egypt	Gastro-enterolgy surgical center, Mansoura University	Mansoura	Al-Dakahleia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss during hepatectomy	bleeding during transection phase will be calculated in mL. based on the blood in the sucker machine and the surgical towels	intraoperative
Secondary	transection speed	the transection speed will be calculated in minutes based on the relation between the transecition time divided by the surface area of the raw area of the graft measured on the backtable.	intraoperative
Secondary	liver pathology from the cut margin	the area of necrosis will be measured in millimeters by the pathologist	intraoperative