Quality of Life and Liver Metastases

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00184834
Collaborator
(none)
100
1
41
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Study Details

Study Description

Brief Summary

An increasing aggressiveness in the surgical approach of colorectal liver metastases is observed. This seems only justified when, besides prolongation of survival, also the health status of patients is considered. The aim of this prospective study is to investigate the impact of surgery on health-related quality of life in this specific patient population operated for colorectal liver metastases.Furthermore, as the indications for hepatic resection are broadened and patients with more extensive liver disease are operated on, the chance of non operable disease at laparotomy will increase. The effects of such an event on HRQol are also studied.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: quality of life

Detailed Description

In a prospective study several patients groups were identified. Patients undergoing liver resection and/or local ablative therapy. Patients with non operable disease at (explorative) laparotomy and outpatients with non operable disease as shown during work up for liver resection. Several validated instruments on HRQoL were ompleted preoperatively (baseline), a half month after operation and then every three months.

Study Design

Study Type:
Observational
Observational Model:
Defined Population
Time Perspective:
Prospective
Official Title:
Quality of Life After Surgical Treatment of Colorectal Liver Metastases
Study Start Date :
Jun 1, 1999
Study Completion Date :
Nov 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    colorectal liver metastases (operable and non operable disease) and participation by means of filling in quality of life instruments

    Exclusion Criteria:

    drop out and therefore loss of quality of life instruments

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboud University Nijmegen Medical Centre Nijmegen Netherlands 6500 HB

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

    • Principal Investigator: Theo Ruers, MD, PhD, Radboud University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00184834
    Other Study ID Numbers:
    • qol1
    First Posted:
    Sep 16, 2005
    Last Update Posted:
    Sep 16, 2005
    Last Verified:
    Sep 1, 2005

    Study Results

    No Results Posted as of Sep 16, 2005