Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy

NCT ID: NCT02853981

Last Updated: 2018-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatic Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Harmonic scalpel group

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

Group Type ACTIVE_COMPARATOR

Harmonic scalpel

Intervention Type DEVICE

a method for liver parenchymal transection

clamp-crush group

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

Group Type ACTIVE_COMPARATOR

Kelly clamp crush technique

Intervention Type DEVICE

a method for liver parenchymal transection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Harmonic scalpel

a method for liver parenchymal transection

Intervention Type DEVICE

Kelly clamp crush technique

a method for liver parenchymal transection

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Liver right lobe donors

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmad Mohammad Ahmad Sultan

Assistant professor of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmad M Sultan, MD

Role: STUDY_DIRECTOR

Assistant prof of general surgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gastro-enterolgy surgical center, Mansoura University

Al Mansurah, Al-Dakahleia, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30671805 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GEC_LTx_Surg_216

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.