Trial document





This trial has been registered retrospectively.
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  DRKS00018987

Trial Description

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Title

The “FRAGILE” Trial: A Randomized Controlled Trial on the Clinical Efficacy of a Multidisciplinary Coordinated Geriatric Ward in Reducing Postoperative Complications in Elderly Pre-Frail, Frail, and Sarcopenic Patients Undergoing Elective Colorectal Cancer Surgery

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Trial Acronym

The “FRAGILE” Trial

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study will investigate whether inpatient care on a geriatric ward after elective surgery for colon and rectal cancer could result in fewer costs and complications compared to care on a normal surgical ward.

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Brief Summary in Scientific Language

The objective of this exploratory, pilot-phase study is to compare (in terms of cost-efficacy, safety, efficacy, and costs) a multidisciplinary geriatric ward to a standard surgical ward, for the post-operative care of elderly patients receiving elective surgery for colorectal cancer.

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Organizational Data

  •   DRKS00018987
  •   2019/11/07
  •   [---]*
  •   yes
  •   Approved
  •   S-565/2018, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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

  •   C18 -  Malignant neoplasm of colon
  •   R68.8 -  Other specified general symptoms and signs
  •   C19 -  Malignant neoplasm of rectosigmoid junction
  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   Arm A (experimental): Multidisciplinary geriatric ward
  •   Arm B (control): Contemporary surgical ward
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Cost-efficacy, measured as all treatment costs, on the 1st to 30th days post-op, divided by the quality-adjusted life-years for the first 30 days post-op, based on the EQ-5D-5L assessed at discharge and extrapolated forward and backward across the month.

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Secondary Outcome

1. Patient-reported outcomes at discharge: physical function (PROMIS short v.2.0 Physical Function 4a), independence of self-care (Katz ADL), pain (VAS), satisfaction (VAS), mental health (BSI-18), general QoL (EQ-5D-5L), disease-specific QoL (EORTS QLQ CR29).
2. Medical outcomes at discharge: change of BMI, muscle strength (grip dynamometer), muscle performance (chair stand test), mobility (time to walk 5m), nutrition (SNAQ), cognitive status (MMSE).
3. Administrative outcomes: length of post-op stay, type of residence for discharge.
4. Financial outcomes: total cost of 30-day post-op care not due to preexisting chronic conditions or other preplanned treatments.
5. Safety outcomes: 30-day mortality; 30-day SAEs (frequency & severity), 30-day infection rate, 30-day morbidity (POMS), 30-day readmission rate, 30-day reoperation rate.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/10/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. age ≥70 years old;
2. diagnosis of colorectal cancer;
3. scheduled for elective surgery (for that colorectal cancer);
4. willingness to accept study allocation to either the surgical or the multidisciplinary geriatric ward;
5. Capacity to provide written informed consent;
6. BRASS Score ≥10.

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Exclusion Criteria

1. a history of prior surgery for colorectal cancer
2. acute colon surgery cases;
3. patients requiring emergency surgery;
4. palliative surgery cases (surgery with the intention of improving quality of life for advanced non-curable disease);
5. nursing home residents requiring full nursing care on admission corresponding to a BRASS Score >30;
6. dementia or other cognitive impairment – at the time of the eligibility screening – sufficient to make completion of the study questionnaires impossible even with the full support of a study nurse;
7. lack of written informed consent;
8. the operating surgeon makes a decision, at the end of the operation and just prior to randomization, that the patient needs post-operative care on the ICU and is not fit for randomization to immediate post-op treatment on either the standard surgical ward or the multidisciplinary geriatric ward, (cf. the section on randomization).

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Addresses

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    • KLINIKUM ASCHAFFENBURG, CHIRURGISCHE KLINIK I, ALLGEMEIN-, VISZERAL- UND GEFÄSSCHIRURGIE
    • Mr.  Prof. Dr. med  Friedrich Hubertus  Schmitz-Winnenthal 
    • Am Hasenkopf 1
    • 63739  Aschaffenburg
    • Germany
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    • KLINIKUM ASCHAFFENBURG, CHIRURGISCHE KLINIK I, ALLGEMEIN-, VISZERAL- UND GEFÄSSCHIRURGIE
    • Mr.  Dr. medic  George-Octavian  Popescu 
    • Am Hasenkopf 1
    • 63739  Aschaffenburg
    • Germany
    end of 1:1-Block address scientific-contact
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  • start of 1:1-Block address public-contact
    • KLINIKUM ASCHAFFENBURG, CHIRURGISCHE KLINIK I, ALLGEMEIN-, VISZERAL- UND GEFÄSSCHIRURGIE
    • Mr.  Dr. medic  George-Octavian  Popescu 
    • Am Hasenkopf 1
    • 63739  Aschaffenburg
    • Germany
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Sources of Monetary or Material Support

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    • KLINIKUM ASCHAFFENBURG, CHIRURGISCHE KLINIK I, ALLGEMEIN-, VISZERAL- UND GEFÄSSCHIRURGIE
    • Mr.  Prof. Dr. med  Friedrich Hubertus  Schmitz-Winnenthal 
    • Am Hasenkopf 1
    • 63739  Aschaffenburg
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Ethikvotum
  •   Protokoll
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* This entry means the parameter is not applicable or has not been set.