Trial document





This trial has been registered retrospectively.
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  DRKS00005150

Trial Description

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Title

Patient empowerment and risk–assessment to improve outcome in the elderly after gastrointestinal, thoracic or urogenital cancer surgery - Pilot study

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Trial Acronym

PERATECS (pilot study)

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Observational study: Quality of life and life style risk in elderly patients with cancer will be assessed up to one year after onco-surgery. A preoperative risk assessment particular in elderly patients for reducing short- and long-term postoperative risks will be evaluated.

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Brief Summary in Scientific Language

In this study, elderly patients who are scheduled for onco-surgery should get a geriatric assessment prior to surgery. Additionally, quality of life, life style risk and comorbidities will be assessed. The patients will be visited daily on the first five days after surgery and on the eigth day as well as on the day of discharge.
Complications, pain, mobility and length of hospital stay will be assessed prospectively. A follow up after 3 and after 12 months will be conducted. Patients will get mailed questionnaire regarding quality of life, functional status and the daily situation. Aim of this study is a perioperative risk assessment in elderly patients for reducing short- and long-term perioperative risk.

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Organizational Data

  •   DRKS00005150
  •   2013/07/16
  •   [---]*
  •   yes
  •   Approved
  •   EA2/103/07, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   elderly patients with cancer
  •   Perioperative riskassessment and long-term outcome after onco-surgery
  •   C51 -  Malignant neoplasm of vulva
  •   C68 -  Malignant neoplasm of other and unspecified urinary organs
  •   C15-C26 -  Malignant neoplasms of digestive organs
  •   C30-C39 -  Malignant neoplasms of respiratory and intrathoracic organs
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Interventions/Observational Groups

  •   Prior to surgery: geriatric assessment including activity of daily living (ADL, Barthel), IADL, ECOG Performance State, mini nutritional assessment (MNA) , mini mental state (MMSE), geriatric depression scale (GDS), Brief fatigue inventory (BFI), assessment of life style risk (nicotin, alcohol: Fagerstroem and AUDIT questionnaires) quality of life (EORTC-QLQ-C30) ,and comorbidities (Charlson Comorbidity index).
    Day 1-5 after surgery, day 8 after surgery, day of discharge: Assessment of complications (Clavien Scale), pain (Numeric rating scale, plus pain therapy), mobility and length of hospital stay.
    Follow up after 3 and 12 months: Mailed questionnaire regarding quality of life(EORTC QLQ C30), functional status (Barthel ADL, IADL) and sociodemographic situation.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Mortality (deceased/ not deceased) and Quality of life (EORTC-QLQ C30 Questionnaire) one year after surgery

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Secondary Outcome

1. short-term morbidity (postoperative complications,measured with the Clavien Scale)
2. Length of hospital stay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2008/06/09
  •   145
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

• Written informed consent by the patient
• Patients aged ≥ 65 years with gastrointestinal (upper gastrointestinal, colorectal), thoracic and urogenital (prostate gland, uterine) malignancies scheduled for surgery
• Mini Mental State > 23
• Life-expectance > 2 months

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Exclusion Criteria

• No informed consent by the patient
• Failure to obtain consent
• Emergent patients
• Outpatients,
• Participation in another clinical study
• Patients with concurrent malignancies


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Addresses

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    • Univ-Klinik für Anästhesiologie m. S. operative Intensivmedizin,Campus Virchow-Klinikum und Charité Mitte, Charité Universitätsmedizin Berlin
    • Ms.  Univ-Prof. Dr. med.   Claudia  Spies 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Univ-Klinik für Anästhesiologie m. S. operative Intensivmedizin, CVK/CCM, Charité-Universitätsmedizin Berlin
    • Ms.  Univ-Prof. Dr. med.  Claudia  Spies 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Sekretariat der Univ-Klinik für Anästhesioloige m.S. operative Intensivmedizin Charité Campus Virchow Klinikum, KAI Sekretariat
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/10/01
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Trial Publications, Results and other Documents

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