The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 8 for:    PORTAL | Bern, Switzerland
Previous Study | Return to List | Next Study

Quality of Life After Liver Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00681499
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : November 13, 2015
Sponsor:
Information provided by:
University of Bern

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Liver Diseases Liver Neoplasms

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 198 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Evaluation of the Quality of Life After Major Hepatic Resection for Malignant and Benign Diseases.
Study Start Date : February 2008
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Quality of Life [ Time Frame: preoperatively, 1-,3-,6-,12 months postoperatively ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients requiring liver resection for any benign or malignant liver diseases, including secondary tumours
Criteria

Inclusion Criteria:

  • Patients with planned liver resection

Exclusion Criteria

  • Patients with biopsy of the liver only
  • Inability of understanding the questionnaire
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681499


Locations
Layout table for location information
Switzerland
Department of visceral and transplant surgery, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
Investigators
Layout table for investigator information
Principal Investigator: Vanessa Banz, MD Dep. of Visceral and transplant Surgery, University Hospital Berne, Switzerland
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Vanessa Banz, MD, Dep. of Visceral and Transplant surgery, Bern University Hospital, Switzerland
ClinicalTrials.gov Identifier: NCT00681499    
Other Study ID Numbers: KEK 18/08
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015
Keywords provided by University of Bern:
Quality of Life
Liver Neoplasms
Surgical procedures, Operative
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Liver Diseases
Neoplasms
 Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site