Quality of Life After Liver Resection - Full Text View

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:

MedlinePlus related topics: Cancer Liver Cancer Liver Diseases

U.S. FDA Resources

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

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:

Cella DF. Quality of life: concepts and definition. J Pain Symptom Manage. 1994 Apr;9(3):186-92.

Slevin ML. Quality of life: philosophical question or clinical reality? BMJ. 1992 Aug 22;305(6851):466-9. No abstract available.

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76.

Kavadas V, Blazeby JM, Conroy T, Sezer O, Holzner B, Koller M, Buckels J; EORTC Quality of Life Group. Development of an EORTC disease-specific quality of life questionnaire for use in patients with liver metastases from colorectal cancer. Eur J Cancer. 2003 Jun;39(9):1259-63. Review.

Sloan JA, Loprinzi CL, Kuross SA, Miser AW, O'Fallon JR, Mahoney MR, Heid IM, Bretscher ME, Vaught NL. Randomized comparison of four tools measuring overall quality of life in patients with advanced cancer. J Clin Oncol. 1998 Nov;16(11):3662-73.

Glimelius B, Hoffman K, Graf W, Påhlman L, Sjödén PO. Quality of life during chemotherapy in patients with symptomatic advanced colorectal cancer. The Nordic Gastrointestinal Tumor Adjuvant Therapy Group. Cancer. 1994 Feb 1;73(3):556-62.

Sterkenburg CA, King B, Woodward CA. A reliability and validity study of the McMaster Quality of Life Scale (MQLS) for a palliative population. J Palliat Care. 1996 Spring;12(1):18-25.

Brunelli C, Costantini M, Di Giulio P, Gallucci M, Fusco F, Miccinesi G, Paci E, Peruselli C, Morino P, Piazza M, Tamburini M, Toscani F. Quality-of-life evaluation: when do terminal cancer patients and health-care providers agree? J Pain Symptom Manage. 1998 Mar;15(3):151-8.

Tamames S, De Vega DS, Tamames S Jr. Surgical management of malignant tumors of the esophagogastric junction: a retrospective review of 188 patients. Int Surg. 1990 Apr-Jun;75(2):89-92.

Martin RC, Eid S, Scoggins CR, McMasters KM. Health-related quality of life: return to baseline after major and minor liver resection. Surgery. 2007 Nov;142(5):676-84.

Chen L, Liu Y, Li GG, Tao SF, Xu Y, Tian H. Quality of life in patients with liver cancer after operation: a 2-year follow-up study. Hepatobiliary Pancreat Dis Int. 2004 Nov;3(4):530-3.

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 11, 2013
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 May 22, 2013