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

Completed

• Conditions: Advanced Cancer

• Registration Number: NCT01367795
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-14
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life 4 weeks after palliative surgery	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).

Secondary Outcome Measures

Name	Time	Method
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	the participants will be followed for the duration of hospital stay, an expected average of 2 weeks	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	the participants will be followed for the duration of hospital stay, an expected average of 2 weeks	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.

Trial Locations

Locations (2)

Hospital Biel, Department for Surgery; 🇨🇭 Basel, Switzerland

Kantonsspital Olten, Department for Surgery; 🇨🇭 Olten, Solothurn, Switzerland