Quality of Life After Liver Resection

Liver Diseases Clinical Trial

Official title:

Long-term Evaluation of the Quality of Life After Major Hepatic Resection for Malignant and Benign Diseases.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681499
• Other study ID #: KEK 18/08
• Status: Completed
• Phase: N/A
• First received: May 19, 2008
• Last updated: November 12, 2015
• Start date: February 2008
• Est. completion date: January 2014

Study information

• Verified date: November 2015
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with planned liver resection

Exclusion Criteria

• Patients with biopsy of the liver only

• Inability of understanding the questionnaire

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Liver Diseases
• Liver Neoplasms

Locations

Country	Name	City	State
Switzerland	Department of visceral and transplant surgery, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (11)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Slevin ML. Quality of life: philosophical question or clinical reality? BMJ. 1992 Aug 22;305(6851):466-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life		preoperatively, 1-,3-,6-,12 months postoperatively	No