Surgical Procedures for Advanced Tumor Disease. A Prospective Study Evaluating Quality of Life

NCT ID: NCT01367795

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 26 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-10-31

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.

Conditions

Advanced Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

palliative tumor disease

Patients in a known palliative setting with symptoms due to tumor growth.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kantonsspital Olten

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carsten T. Viehl, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University Hospital of Basel

Locations

Hospital Biel, Department for Surgery

Basel, Basel, Switzerland

Kantonsspital Olten, Department for Surgery

Olten, Canton of Solothurn, Switzerland

Countries

Switzerland

Other Identifiers

EK 2011/070

Identifier Type: OTHER

Identifier Source: secondary_id

EK 10/10

Identifier Type: -

Identifier Source: org_study_id