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

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 Overview

• Status: Completed
• Conditions: Advanced Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 2501
    • Hospital Biel, Department for Surgery
  • Solothurn
    • Olten, Solothurn, Switzerland, 4460
      • Kantonsspital Olten, Department for Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
palliative tumor disease; Patients in a known palliative setting with symptoms due to tumor growth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life 4 weeks after palliative surgery	Quality of life will be measured by the questionnaire EORTC-QLQ-C30 (European Organization for Research and Treatment of Cancer-Quality of Life).	4 weeks after palliative surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of stay in hospital		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
duration of stay in an intensive care unit		participants will be followed for the duration of stay in an intensive care unit, an expected average of 0 to 2 days
complications	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.	the participants will be followed for the duration of hospital stay, an expected average of 2 weeks
reoperations	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.	the participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Kantonsspital Olten
• Investigators: Principal Investigator: Carsten T. Viehl, MD, Department of Surgery, University Hospital of Basel

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: July 14, 2010
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (Estimate): June 7, 2011

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 26, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: quality of life; surgery; palliation; lifestyle; surgery; palliative
• Other Study ID Numbers: EK 10/10; EK 2011/070 (Other Identifier: Ethikkommission Aargau/ Solothurn)