Quality of Life After Liver Resection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00681499
First received: May 19, 2008
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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
Liver Diseases
Liver Neoplasms

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Bern:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: preoperatively, 1-,3-,6-,12 months postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2008
Estimated Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
malignant
eg. hepatocellular carcinoma, colorectal liver metastases
benign
eg. liver cysts, traumatic liver injuries, adenoma etc

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681499

Locations
Switzerland
Department of visceral and transplant surgery, Bern University Hospital
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
Investigators
Principal Investigator: Vanessa Banz, MD Dep. of Visceral and transplant Surgery, University Hospital Berne, Switzerland
  More Information

Publications:

Responsible Party: Vanessa Banz, MD, Dep. of Visceral and Transplant surgery, Bern University Hospital, Switzerland
ClinicalTrials.gov Identifier: NCT00681499     History of Changes
Other Study ID Numbers: KEK 18/08
Study First Received: May 19, 2008
Last Updated: January 21, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Bern:
Quality of Life
Liver Neoplasms
Surgical procedures, Operative

Additional relevant MeSH terms:
Neoplasms
Liver Diseases
Liver Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on July 24, 2014