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| Sponsored by: |
University of Bern |
|---|---|
| Information provided by: | University of Bern |
| ClinicalTrials.gov Identifier: | NCT00681499 |
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: | Cohort, Prospective |
| Official Title: | Long-Term Evaluation of the Quality of Life After Major Hepatic Resection for Malignant and Benign Diseases. |
| Estimated Enrollment: | 2 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
malignant
eg. hepatocellular carcinoma, colorectal liver metastases etc
|
|
benign
eg. liver cysts, traumatic liver injuries, adenoma etc
|
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 |
All patients requiring liver resection for any benign or malignant liver diseases, including secondary tumours
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Brigitte Wanner, Study Nurse | +41 31 632 21 11 | brigitte.wanner@insel.ch |
| Contact: Jacqueline Pulver, Study Nurse | +41 31 632 21 11 | jacqueline.pulver@insel.ch |
| Switzerland | |
| Department of visceral and transplant surgery, Bern University Hospital | Recruiting |
| Bern, Switzerland, 3010 | |
| Contact: Vanessa Banz, MD +41 31 632 21 11 vanessa.banz@insel.ch | |
| Contact: Brigitte Wanner, Study Nurse +41 31 632 21 11 brigitte.wanner@insel.ch | |
| Principal Investigator: Vanessa Banz, MD | |
| Principal Investigator: | Vanessa Banz, MD | Dep. of Visceral and transplant Surgery, University Hospital Berne, Switzerland |
More Information
| Responsible Party: | Dep. of Visceral and Transplant surgery, Bern University Hospital, Switzerland ( Vanessa Banz, MD ) |
| Study ID Numbers: | KEK 18/08 |
| Study First Received: | May 19, 2008 |
| Last Updated: | May 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00681499 |
| Health Authority: | Switzerland: Ethikkommission |
|
Quality of Life Liver Neoplasms Surgical procedures, Operative |
|
Liver Neoplasms Liver Diseases Digestive System Neoplasms Digestive System Diseases |
Liver neoplasms Quality of Life Gastrointestinal Neoplasms |
|
Neoplasms Neoplasms by Site |
