NCT00184834

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 1999

Typical duration 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

June 1, 1999

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

September 16, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Colorectal Liver MetastasesQuality of Life

Keywords

colorectallivermetastaseshealth-related quality of lifesurgery

Interventions

quality of lifeBEHAVIORAL

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • drop out and therefore loss of quality of life instruments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related 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. doi: 10.1046/j.1365-2168.2001.01755.x.

    PMID: 11350434BACKGROUND

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Theo Ruers, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

June 1, 1999

Study Completion

November 1, 2002

Last Updated

September 16, 2005

Record last verified: 2005-09

Locations

NL(1)