Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life
Recruitment status was Recruiting
Patients in a known palliative setting and with localized symptoms due to tumor growth will be evaluated for their quality of life before and after a surgical intervention (primary endpoint). Medical outcome in terms of length of stay in hospital, length of stay on a intensive care unit, complications, reinterventions will be recorded (secondary endpoints). The investigators will also observe patients with conservative treatment.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life|
- Quality of life 4 weeks after palliative surgery [ Time Frame: 4 weeks after palliative surgery ] [ Designated as safety issue: No ]Quality of life will be measured by the questionnaire EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer-Quality of Life).
- duration of stay in hospital [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
- duration of stay in an intensive care unit [ Time Frame: participants will be followed for the duration of stay in an intensive care unit, an expected average of 0 to 2 days ] [ Designated as safety issue: No ]
- complications [ Time Frame: the participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]Complications will be recorded following the Clavien-Dindo classification of surgical complications. This 5-scale classification is based on the type of therapy needed to correct the complications.
- reoperations [ Time Frame: the participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]The need for reoperations is generally part of the 5-class complication scale by Clavien and Dindo, which we are using to record complications. Reoperations (class IIIb in the classification of complications) are recorded seperately.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||September 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
palliative tumor disease
Patients in a known palliative setting with symptoms due to tumor growth.
What is the impact on quality of life by operations in symptomatic advanced tumor disease ? After informed consent patients in known palliative situations and with localized symptoms due to tumor growth will be enrolled in our study. The investigators will assess Quality of life with the EORTC QLQ C30-questionnaire and collect data about the disease an the actual state of the patients.
By the time of discharge out of hospital the investigators will hand out the questionnaire again and the investigators will collect data regarding the therapies, operations, complications, reinterventions, time spent on a intensive care unit, time spent in hospital.
The questionnaire will be completed after 4 and 12 weeks as well.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367795
|Contact: Anke M. Mols, MD||+41 62 311 firstname.lastname@example.org|
|Contact: Carsten T. Viehl, MD||+41 61 265 71 88||ViehlC@uhbs.ch|
|Kantonsspital Olten, Department for Surgery||Recruiting|
|Olten, Solothurn, Switzerland, 4460|
|Contact: Anke M Mols, MD 0041 62 311 5148 email@example.com|
|Contact: Markus M Zuber, Professor 0041 62 311 4230 firstname.lastname@example.org|
|University Hospital of Basel, Department for Surgery||Recruiting|
|Basel, Switzerland, 4310|
|Contact: Carsten T Viehl, MD 0041 61 265 2525 email@example.com|
|Principal Investigator:||Carsten T. Viehl, MD||Department of Surgery, University Hospital of Basel|