NCT02853981

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

March 11, 2016

Last Update Submit

January 17, 2018

Conditions

Hepatic Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • transection speed

    intraoperative

  • liver pathology from the cut margin

    intraoperative

Study Arms (2)

Harmonic scalpel group

ACTIVE COMPARATOR

group of donors whom will undergo liver transection using harmonic scalpel.

Device: Harmonic scalpel

clamp-crush group

ACTIVE COMPARATOR

group of donors whom will undergo liver transection using Kelly clamp.

Device: Kelly clamp crush technique

Interventions

Harmonic scalpelDEVICE

a method for liver parenchymal transection

Harmonic scalpel group
Kelly clamp crush techniqueDEVICE

a method for liver parenchymal transection

clamp-crush group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Liver right lobe donors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastro-enterolgy surgical center, Mansoura University

Al Mansurah, Al-Dakahleia, 35516, Egypt

Location

Related Publications (1)

  • Sultan AM, Shehta A, Salah T, Elshoubary M, Elghawalby AN, Said R, Elmorshedi M, Marwan A, Shiha U, Fathy O, Wahab MA. Clamp-Crush Technique Versus Harmonic Scalpel for Hepatic Parenchymal Transection in Living Donor Hepatectomy: a Randomized Controlled Trial. J Gastrointest Surg. 2019 Aug;23(8):1568-1577. doi: 10.1007/s11605-019-04103-5. Epub 2019 Jan 22.

    PMID: 30671805DERIVED

Study Officials

  • Ahmad M Sultan, MD

    Assistant prof of general surgery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of general surgery

Study Record Dates

First Submitted

March 11, 2016

First Posted

August 3, 2016

Study Start

January 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

EG(1)