Improving surgery outcomes for frail elderly patients with colorectal cancer
Effect of CGA for Frail Elderly Patients Operated for Colorectal Cancer - The CRC Frailty-study Can Preoperative Comprehensive Geriatric Assessment and Care in Addition to Standard ERAS Protocol Reduce Mortality After Colorectal Surgery for Carcinoma in the Frail Elderly?
This study is testing whether personalized care plans can help frail elderly patients over 70 recover better after surgery for colorectal cancer compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Sahlgrenska University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Gothenburg, Västra Götalandsregionen and 1 other locations) |
| Trial ID | NCT04358328 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial investigates the impact of individualized comprehensive geriatric assessment (CGA) and care on postoperative outcomes in frail elderly patients undergoing surgery for colorectal cancer. The study focuses on patients aged 70 and older, who are at higher risk for complications due to frailty. By applying the ERAS (Enhanced Recovery After Surgery) concept, the trial aims to enhance recovery and reduce morbidity in this vulnerable population. The effectiveness of CGA will be compared to standard care to determine its benefits in improving surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are frail elderly patients aged 70 and older with potentially curable colorectal cancer.
Not a fit: Patients who are terminally ill, in a palliative situation, or unable to understand study information may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and reduce complications for frail elderly patients undergoing colorectal cancer surgery.
How similar studies have performed: Previous studies have shown that addressing frailty in surgical patients can lead to improved outcomes, indicating that this approach has potential based on existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Potentially curable colorectal cancer (according to cTNM) * ≥ 70 years old * Frailty (CFS-9 v2.0 score 4-8) Exclusion Criteria: * Palliative situation * Unable to understand study information * Acute surgery * Terminally ill patient (CFS-9 9) * Less than 6 months expected survival * Not willing to participate
Where this trial is running
Gothenburg, Västra Götalandsregionen and 1 other locations
- Sahlgrenska University Hospital — Gothenburg, Västra Götalandsregionen, Sweden (Recruiting)
- Department of Surgery, NU-Hospital/NÄL — Trollhättan, Västra Götalandsregionen, Sweden (Recruiting)
Study contacts
- Principal investigator: Mattias Prytz, MD, PhD — Department of Surgery, NU-Hospital Organization
- Study coordinator: Mattias Prytz, MD, PhD
- Email: mattias.prytz@vgregion.se
- Phone: 010-4353523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.