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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367795
• Other study ID #: EK 10/10
• Secondary ID: EK 2011/070
• Status: Completed
• Phase: N/A
• First received: July 14, 2010
• Last updated: March 26, 2015
• Start date: July 2010
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Cancer

Locations

Country	Name	City	State
Switzerland	Hospital Biel, Department for Surgery	Basel
Switzerland	Kantonsspital Olten, Department for Surgery	Olten	Solothurn

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Kantonsspital Olten

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	duration of stay in hospital		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No