Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Quality of Life and Liver Metastases

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00184834
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention
Colorectal Liver Metastases
Quality of Life
Behavioral: quality of life

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Quality of Life After Surgical Treatment of Colorectal Liver Metastases

Resource links provided by NLM:


Further study details as provided by Radboud University:

Estimated Enrollment: 100
Study Start Date: June 1999
Estimated Study Completion Date: November 2002
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184834

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Theo Ruers, MD, PhD Radboud University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00184834     History of Changes
Other Study ID Numbers: qol1
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
colorectal
liver
metastases
health-related quality of life
surgery

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014