Clinical trial NCT00681499: Quality of Life After Liver Resection
Official title: Long-term Evaluation of the Quality of Life After Major Hepatic Resection for Malignant and Benign Diseases.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Liver Neoplasms
Keywords: Quality of Life
Liver Neoplasms
Surgical procedures, Operative
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2008-05-21
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients requiring liver resection for any benign or malignant liver diseases, including secondary tumours

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.

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 criteria: Inclusion Criteria:

* Patients with planned liver resection

Exclusion Criteria

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

Primary outcomes:
measure: Quality of Life
timeFrame: preoperatively, 1-,3-,6-,12 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of visceral and transplant surgery, Bern University Hospital
Study officials:
affiliation: Dep. of Visceral and transplant Surgery, University Hospital Berne, Switzerland
name: Vanessa Banz, MD
role: PRINCIPAL_INVESTIGATOR
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