Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
198 participants
OBSERVATIONAL
2008-02-29
2014-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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malignant
eg. hepatocellular carcinoma, colorectal liver metastases
No interventions assigned to this group
benign
eg. liver cysts, traumatic liver injuries, adenoma etc
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Inability of understanding the questionnaire
18 Years
ALL
No
Sponsors
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University of Bern
OTHER
Responsible Party
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Dep. of Visceral and Transplant surgery, Bern University Hospital, Switzerland
Principal Investigators
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Vanessa Banz, MD
Role: PRINCIPAL_INVESTIGATOR
Dep. of Visceral and transplant Surgery, University Hospital Berne, Switzerland
Locations
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Department of visceral and transplant surgery, Bern University Hospital
Bern, , Switzerland
Countries
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References
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Cella DF. Quality of life: concepts and definition. J Pain Symptom Manage. 1994 Apr;9(3):186-92. doi: 10.1016/0885-3924(94)90129-5.
Slevin ML. Quality of life: philosophical question or clinical reality? BMJ. 1992 Aug 22;305(6851):466-9. doi: 10.1136/bmj.305.6851.466. 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. doi: 10.1093/jnci/85.5.365.
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. doi: 10.1016/s0959-8049(03)00236-3.
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. doi: 10.1200/JCO.1998.16.11.3662.
Glimelius B, Hoffman K, Graf W, Pahlman L, Sjoden 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. doi: 10.1002/1097-0142(19940201)73:33.0.co;2-8.
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. doi: 10.1016/s0885-3924(97)00351-5.
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. doi: 10.1016/j.surg.2007.04.026.
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.
Other Identifiers
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KEK 18/08
Identifier Type: -
Identifier Source: org_study_id
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