Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01768728
NCT01768728CompletedNot Applicable

A Randomized Controlled Trial of Acute Surgical Trauma and Stress Response of Laparoscopic Versus Open Left Hemihepatectomy for Liver Benign Lesions

Sir Run Run Shaw Hospital1 site in 1 country60 target enrollmentStarted: December 1, 2012Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Plasma C-reactive protein (CRP) level
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Laparoscopic left hemihepatectomy group

Active Comparator

Group of patients that are operated with laparoscopic left hemihepatectomy

Intervention: Laparoscopic left hemihepatectomy (Procedure)

Open left hemihepatectomy

Active Comparator

Group of patients operated with open left hemihepatectomy

Intervention: Open left hemihepatectomy (Procedure)

Outcomes

Primary Outcomes

Plasma C-reactive protein (CRP) level

Time Frame: up to 7 days

CRP will be tested before operation, 3,12,24 hours and 3,5,7 days after operation

Secondary Outcomes

  • Inflammatory response markers including interleukin-6, interleukin-10 concentrations and tumor necrosis factor α level in serum(up to 7 days)
  • Systemic inflammatory response syndrome(up to 7 days)
  • Oxidative stress status including plasma malondialdehyde level and total antioxidant capacity(up to 7 days)
  • Immune status including white blood cell count and human leukocyte antigen DR (HLA-DR) expression(up to 7 days)
  • Status of insulin resistant(up to 7 days)
  • Status of hepatic cell apoptosis including hematoxylin and eosin (HE) staining, immunohistochemistry staining and caspase-3 expression(24 hours)
  • Time to functional recovery(Participants will be followed for the duration of hospital stay, an expected average of 7 days)
  • Postoperative hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 8 days)
  • Morbidity and mortality(up to 1 month)
  • Quality of life(up to 1 month)
  • Intraoperative parameters including operation time, pneumoperitoneum time, liver resection time, intraoperative estimated blood loss,transfusion(participants will be followed for the duration of operation, an expected average of 120 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiujun Cai

Executive Vice-President

Sir Run Run Shaw Hospital

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Not Applicable
Laparoscopic Versus Open Liver Resection for Hepatocellular CarcinomaHepatocellular Carcinoma
NCT02526043Fudan University180
Completed
Not Applicable
Laparoscopic Hepatectomy and Radiofrequency Ablation in the Treatment of Early Hepatocellular CarcinomaHepatocellular Carcinoma
NCT02243384ChenJian150
Recruiting
Phase 3
Safety Study of Totally Laparoscopic Resection With Natural Orifice Specimen Extraction (NOSE) for Rectosigmoid CancerColorectal Cancer
NCT02635503Cancer Institute and Hospital, Chinese Academy of Medical Sciences366
Completed
Not Applicable
Effects of Salpingectomy During Laparoscopic Hysterectomy on Ovarian FunctionLaparoscopic Hysterectomy
NCT01578759University of North Carolina, Chapel Hill30
Not yet recruiting
Not Applicable
Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair with Sutures Alone versus Sutures Reinforced with Mesh for Hiatus Hernia.Hiatus Hernia
NL-OMON23150Antonius Ziekenhuis, Nieuwegein72