Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-28 @ 11:18 PM
Study NCT ID:
NCT05851235
Status:
UNKNOWN
Last Update Posted:
2023-05-09
First Post:
2023-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prehabilitation in Geriatric Patients With Colorectal Neoplasia
Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Organization:
Study Overview
Official Title:
Results of a Programme of Intensive Prehabilitation in GEriatric Patients Operated for Colo-Rectal Neoplasia
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIGEON
Brief Summary:
This an interventional, non-pharmacologic study. Prehabilitation is a multidisciplinary preoperative intervention aimed at preventing or reducing functional decline related to surgery and improving perioperative outcomes. The current study is aimed at standardizing a prehabilitation pathway, evaluating its feasibility within the AUSL Romagna in collaboration with the PRIME Centre and the multiple professions that populate the two institutes in the spirit of confirming the beneficial effect of an integrated prehabilitation programme on surgical outcomes.
Patients will follow an intensive prehabilitation course before surgery:
* Colon cancer patients will do 4 weeks of prehabilitation before surgery.
* Rectal cancer patients will do 12 weeks of prehabilitation after neoadjuvant therapy and before surgery.
The prehabilitation course is structured around the following aspects:
* Frailty assessment and identification of optimisation fields
* Optimisation of modifiable factors (anaemia, polypharmacotherapy, smoking, alcoholism, diabetes)
* Assessment by an integrative medicine specialist
* Nutritional pre-qualification
* Cardiovascular, respiratory, motor prehabilitation
* Emotional and psychological prehabilitation
Patients will follow an intensive prehabilitation course before surgery:
* Colon cancer patients will do 4 weeks of prehabilitation before surgery.
* Rectal cancer patients will do 12 weeks of prehabilitation after neoadjuvant therapy and before surgery.
The prehabilitation course is structured around the following aspects:
* Frailty assessment and identification of optimisation fields
* Optimisation of modifiable factors (anaemia, polypharmacotherapy, smoking, alcoholism, diabetes)
* Assessment by an integrative medicine specialist
* Nutritional pre-qualification
* Cardiovascular, respiratory, motor prehabilitation
* Emotional and psychological prehabilitation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: