Quality of Life After Liver Resection

November 12, 2015 updated by: University of Bern

Long-term Evaluation of the Quality of Life After Major Hepatic Resection for Malignant and Benign Diseases.

Patients with malignant diseases are increasingly receiving more extensive hepatic resections, with im-proved preoperative and postoperative care leading to a reduced postoperative morbidity and mortality. In this setting, postoperative quality of life may become as important as overall patient survival. In this study we will be investigating the effect of the initial disease for which hepatic resection was carried out on short- and long-term quality of life.

Study Overview

Status

Completed

Conditions

Detailed Description

Background: Due to advances in operative methods and perioperative care, mortality and morbidity following major hepatic resection have decreased substantially, making long-term quality of life (QoL) an increasingly prominent issue.

Objectives: We plan on evaluating whether postoperative diagnosis is associated with long-term QoL and health in patients who require hepatic surgery for benign or malignant diseases and how QoL evolves with time.

Method: QoL will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 and the liver-specific QLQ-LMC21 module. All patients requiring hepatic surgery aged >18 years will be included in the study. QoL evaluation is carried out preoperatively and at set intervals postoperatively.

Study Type

Observational

Enrollment (Actual)

198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Department of Visceral and Transplant Surgery, Bern University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients requiring liver resection for any benign or malignant liver diseases, including secondary tumours

Description

Inclusion Criteria:

  • Patients with planned liver resection

Exclusion Criteria

  • Patients with biopsy of the liver only
  • Inability of understanding the questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
malignant
eg. hepatocellular carcinoma, colorectal liver metastases
benign
eg. liver cysts, traumatic liver injuries, adenoma etc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of Life
Time Frame: preoperatively, 1-,3-,6-,12 months postoperatively
preoperatively, 1-,3-,6-,12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

  • Principal Investigator: Vanessa Banz, MD, Dep. of Visceral and transplant Surgery, University Hospital Berne, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

May 19, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (ESTIMATE)

May 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 12, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK 18/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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