Quality of Life After Liver Resection

NCT ID: NCT00681499

Last Updated: 2015-11-13

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

198 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2014-01-31

Brief Summary

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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

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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.

Conditions

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Liver Diseases Liver Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* Patients with planned liver resection

Exclusion Criteria

* Patients with biopsy of the liver only
* Inability of understanding the questionnaire
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bern

OTHER

Sponsor Role lead

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

Site Status

Countries

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Switzerland

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.

Reference Type BACKGROUND
PMID: 8014530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1392964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8433390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12763214 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9817289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8299077 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8857243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9564116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2379996 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17981187 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15567739 (View on PubMed)

Other Identifiers

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KEK 18/08

Identifier Type: -

Identifier Source: org_study_id

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