Improving recovery in elderly patients with frailty undergoing surgery for digestive cancer
Effect of Multicomponent Prehabilitation on Early and Long-term Outcomes in Elderly Patients With Frailty After Digestive Surgery for Cancer: A Randomized-controlled Study
This study tests whether a special program that includes nutrition and exercise can help older patients with frailty recover better after surgery for digestive cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 540 (estimated) |
| Ages | 65 Years to 89 Years |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04715581 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of a multicomponent prehabilitation program on elderly patients with frailty who are scheduled for major surgery due to digestive cancer. The program includes preoperative nutritional optimization and exercise training, as well as postoperative rehabilitation. By addressing frailty and malnutrition, the study aims to enhance recovery and improve both short-term and long-term outcomes for these vulnerable patients. The research focuses on understanding how these interventions can mitigate the adverse effects associated with frailty in surgical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 to 89 who are scheduled for major surgery for digestive cancer and exhibit clinical frailty.
Not a fit: Patients with severe comorbidities or those unable to participate in rehabilitation due to movement disorders or severe cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery times and overall outcomes for elderly patients undergoing surgery for digestive cancer.
How similar studies have performed: Other studies have shown promising results with prehabilitation approaches in surgical patients, particularly in improving recovery outcomes, although this specific multicomponent approach is less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Age ≥65 years but \<90 years; 2. Scheduled to undergo major surgery for digestive cancer with an expected duration of 2 hours and longer, including cancers of esophagus, stomach, small intestine, colon, rectum, pancreas, liver, and biliary tract; 3. Clinical Frailty Scale ≥5; 4. Provide written informed consent. Exclusion Criteria: 1. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis; 2. Inability to communicate due to coma, profound dementia, or language barrier; 3. Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder; 4. Inability to take oral diet due to preoperative gastrointestinal disease or other disease; 5. Severe heart dysfunction (left ventricular ejection fraction \<30% or New York Heart Association classification IV), severe hepatic dysfunction (Child-Pugh class C), severe renal dysfunction (undergoing dialysis before surgery), or American Society of Anesthesiologists classification of grade 4 or higher; 6. Other reasons that are considered unsuitable for study participation.
Where this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
- Study coordinator: Dong-Xin Wang, MD
- Email: wangdongxin@hotmail.com
- Phone: +8613910731903
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.