Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions

NCT ID: NCT01768728

Last Updated: 2015-11-18

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Brief Summary

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The purpose of this study is to investigate the influence of the laparoscopic and open left hemihepatectomy on acute surgical trauma and stress response.

Detailed Description

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Conditions

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Benign Lesions in Left Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Laparoscopic left hemihepatectomy group

Group of patients that are operated with laparoscopic left hemihepatectomy

Group Type ACTIVE_COMPARATOR

Laparoscopic left hemihepatectomy

Intervention Type PROCEDURE

participants will be performed with laparoscopic left hepatectomy using laparoscopic instruments

Open left hemihepatectomy

Group of patients operated with open left hemihepatectomy

Group Type ACTIVE_COMPARATOR

Open left hemihepatectomy

Intervention Type PROCEDURE

participants will be performed with traditional open left hepatectomy using laparotomic instruments

Interventions

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Laparoscopic left hemihepatectomy

participants will be performed with laparoscopic left hepatectomy using laparoscopic instruments

Intervention Type PROCEDURE

Open left hemihepatectomy

participants will be performed with traditional open left hepatectomy using laparotomic instruments

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic left hepatectomy Open left hepatectomy

Eligibility Criteria

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Inclusion Criteria

* patient with benign lesions who requires left hemihepatectomy
* Child-Pugh classification of A to B
* American Society Of Anesthesiologists (ASA) grading of I to III
* a body mass index of between 18 and 35
* willingness to participate in the study
* able to understand the nature of the study and what will be required of them

Exclusion Criteria

* pregnant or lactating women
* unwillingness to participate
* Child-Pugh classification of C
* ASA grading of IV to V
* with condition of acute inflammatory,fever or diabetes mellitus
* with autoimmune disease or immunodeficiency
* taking drugs that affect the immune system
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xiujun Cai

Executive Vice-President

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of General Surgery, Institute of Minimally Invasive Surgery, Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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SRRSH20121225-1

Identifier Type: -

Identifier Source: org_study_id