RecruitingNot Applicable

Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty

China540 participantsStarted 2021-11-25

Plain-language summary

The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.

Who can participate

Age range65 Years – 89 Years

SexALL

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Inclusion criteria

✓. Age ≥65 years but \<90 years;
✓. 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;
✓. Clinical Frailty Scale ≥5;
✓. Provide written informed consent.

Exclusion criteria

✕. Preoperative history of schizophrenia, epilepsy, Parkinsonism, or myasthenia gravis;
✕. Inability to communicate due to coma, profound dementia, or language barrier;
✕. Inability to participate in preoperative rehabilitation due to paralysis, fracture or other movement disorder;
✕. Inability to take oral diet due to preoperative gastrointestinal disease or other disease;
✕. 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;
✕. Other reasons that are considered unsuitable for study participation.

What they're measuring

A composite of delirium and non-delirium complications within 7 days after surgery (sub-study).

Timeframe: Up to 7 days after surgery.

Recurrence-free survival after surgery.

Timeframe: Up to two years after surgery.

Trial details

NCT IDNCT04715581

SponsorPeking University First Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Dong-Xin Wang, MD

+8613910731903 wangdongxin@hotmail.com

View on ClinicalTrials.gov More Old Age; Debility trials