NCT00681499

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

5.9 years

First QC Date

May 19, 2008

Last Update Submit

November 12, 2015

Conditions

Keywords

Quality of LifeLiver NeoplasmsSurgical procedures, Operative

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    preoperatively, 1-,3-,6-,12 months postoperatively

Study Arms (2)

malignant

eg. hepatocellular carcinoma, colorectal liver metastases

benign

eg. liver cysts, traumatic liver injuries, adenoma etc

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients requiring liver resection for any benign or malignant liver diseases, including secondary tumours

You may qualify if:

  • Patients with planned liver resection

You may not qualify if:

  • Patients with biopsy of the liver only
  • Inability of understanding the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of visceral and transplant surgery, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (11)

  • 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.

    PMID: 8014530BACKGROUND
  • 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.

    PMID: 1392964BACKGROUND
  • 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.

    PMID: 8433390BACKGROUND
  • 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.

    PMID: 12763214BACKGROUND
  • 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.

    PMID: 9817289BACKGROUND
  • 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.

    PMID: 8299077BACKGROUND
  • 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.

    PMID: 8857243BACKGROUND
  • 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.

    PMID: 9564116BACKGROUND
  • 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.

    PMID: 2379996BACKGROUND
  • 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.

    PMID: 17981187BACKGROUND
  • 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.

    PMID: 15567739BACKGROUND

MeSH Terms

Conditions

Liver DiseasesLiver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Vanessa Banz, MD

    Dep. of Visceral and transplant Surgery, University Hospital Berne, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations