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

Not Applicable

Recruiting

Conditions: C18
R68.8
C19
C20
Malignant neoplasm of colon
Other specified general symptoms and signs
Malignant neoplasm of rectosigmoid junction
Malignant neoplasm of rectum

Registration Number: DRKS00018987

Lead Sponsor: KLINIKUM ASCHAFFENBURG, CHIRURGISCHE KLINIK I, ALLGEMEIN-, VISZERAL- UND GEFÄSSCHIRURGIE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

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.

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).

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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).<br>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).<br>3.Administrative outcomes: length of post-op stay, type of residence for discharge.<br>4.Financial outcomes: total cost of 30-day post-op care not due to preexisting chronic conditions or other preplanned treatments.<br>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.