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Completed

NCT Number: NCT01367795

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.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Biel, Department for Surgery, Basel, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Quality of life 4 weeks after palliative surgery

    Time frame: 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 outcomes

  1. duration of stay in hospital

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  2. duration of stay in an intensive care unit

    Time frame: participants will be followed for the duration of stay in an intensive care unit, an expected average of 0 to 2 days

  3. complications

    Time frame: 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.

  4. reoperations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Kantonsspital Olten

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2011
Registry last updated
Mar 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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