Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery

ConditionGastrointestinal Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorThe Guthrie Clinic

About this trial

This research is for patients who have gastrointestinal cancer and have a planned major surgery. The purpose of this research is to identify cancer patients who may be at risk for frailty. Frailty is common in older adults and may include symptoms of weight loss, weakness, fatigue, low activity, slow walking and other illnesses. Frailty may increase the risk of problems after major surgery. The study will involve a survey, a blood sample, and a review of medical records.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years old or older

histologically proven gastrointestinal malignancy

referral for elective major surgical procedures at including operations for upper and lower gastrointestinal malignancies and hepato-pancreato-biliary

referral for neoadjuvant treatment followed by any of the above major surgical procedures

Disqualifiers

under 18 years

pregnant women

Trial population

Participants with gastrointestinal cancer who are referred for elective major surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Frailty survey
Other intervention
Frailty survey using the Clinical Risk Analysis Index (RAI-C).

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: Major surgery for gastrointestinal cancer1 intervention

Trial outcomes

Primary outcomes

Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher

Assess Clinical Risk Analysis Index (RAI-C) Scores in rural patients referred for major abdominal surgeries. Survey values will be added to yield a final RAI-C score between 0 and 81. Percent of patients considered frail will be defined as Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher

Time frame

pre-operative

Secondary outcomes

Adverse outcomes after major surgery

Assess adverse outcomes postoperatively and if their is a correlation with the frailty score

Time frame

30 days post-operative

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Guthrie Clinic

Lead sponsor

Source ClinicalTrials.gov

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