Clinical trial NCT01367795: Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life
Official title: Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Cancer
Keywords: palliation
quality of life
surgery
surgery; palliative
lifestyle
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Kantonsspital Olten
First posted: 2011-06-07
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in a known tumorrelated palliative situation will be included when an operation is discussed for relieve of symptomatic localised tumor growth . Patients will be recruited from clinics or the emergency room.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* informed consent
* tumor patients within a known palliative situation, patients do know about the absence of a curative treatment
* patients are symptomatic because of localized tumor growth
* patients having an operation for symptom relief or treated without surgery

Exclusion Criteria:

* patients with an only intraoperatively seen palliative tumor disease
* debulking operations, prophylactic operations for prevention of symptoms, operations for venous access (an exception will be made for enteric bypass operations in patients with a yet preserved passage)
* dementia, age ≤ 18, barrier of speech

Primary outcomes:
measure: Quality of life 4 weeks after palliative surgery
timeFrame: 4 weeks after palliative surgery
Secondary outcomes:
measure: duration of stay in hospital
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: duration of stay in an intensive care unit
timeFrame: participants will be followed for the duration of stay in an intensive care unit, an expected average of 0 to 2 days
measure: complications
timeFrame: the participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: reoperations
timeFrame: the participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Olten
country: Switzerland
facility: Kantonsspital Olten, Department for Surgery
state: Solothurn
city: Basel
country: Switzerland
facility: Hospital Biel, Department for Surgery
Study officials:
affiliation: Department of Surgery, University Hospital of Basel
name: Carsten T. Viehl, MD
role: PRINCIPAL_INVESTIGATOR
References: