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NCT00184834 Clinical Trial

Quality of Life and Liver Metastases

Quality of Life Clinical Trial

Official title:
Quality of Life After Surgical Treatment of Colorectal Liver Metastases

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00184834
Other study ID # qol1
Secondary ID
Status Completed
Phase N/A
First received September 12, 2005
Last updated September 12, 2005
Start date June 1999
Est. completion date November 2002

Study information
Verified date September 2005
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date November 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Behavioral:
• quality of life

Locations
Country Name City State
Netherlands Radboud University Nijmegen Medical Centre Nijmegen

Sponsors (1)
Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Langenhoff BS, Krabbe PF, Wobbes T, Ruers TJ. Quality of life as an outcome measure in surgical oncology. Br J Surg. 2001 May;88(5):643-52. Review. — View Citation

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