Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-04-08 @ 9:52 PM
Study NCT ID:
NCT06448494
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the New Peri-Operative Geriatric Units in Ile-de-France, in Digestive and Urological Surgery
Sponsor:
Gérond'if
Organization:
Study Overview
Official Title:
Evaluation of the New Peri-Operative Geriatric Units in Ile-de-France, in Digestive and Urological Surgery
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
UPOG-DIGU
Brief Summary:
The main objective of this study is to evaluate the effectiveness of experimental management by digestive or urological "new Peri-Operative Geriatric Units", on post-operative follow-up in the 3 months following the procedure.
Medical follow-up in the 10 days following the operation up to discharge, and patient outcomes in the 3 months following the operation, will be documented.
These data will be compared with data from subjects operated on in the reference year.
Medical follow-up in the 10 days following the operation up to discharge, and patient outcomes in the 3 months following the operation, will be documented.
These data will be compared with data from subjects operated on in the reference year.
Detailed Description:
This is a multicenter, non-interventional, prospective retrospective study:
* Prospective group: inclusion of patients scheduled to undergo one of the 9 procedures targeted by the "new Peri-Operative Geriatric Units" trial (colectomy, cholecystectomy, , transurethral prostatectomy, transurethral or transcutaneous procedure for non-lithiasis conditions, kidney and ureter procedure and major bladder surgery for tumor condition esophageal, gastric and duodenal procedure for malignancy, transurethral bladder resection)
* Retrospective group: inclusion of patients who were operated in 2019
This study will assess whether "Peri-Operative Geriatric Units" for digestive or urinary surgery is beneficial for :
* Medical follow-up in the 10 days following the operation and up to discharge (simple follow-up, complications, return to the operating room, etc.),
* Patient outcomes in the 3 months following surgery (discharge date, geriatric assessment, rehospitalization, other significant medical events, etc.).
These data will be compared with those of patients operated on in the reference year prior to pandemic Covid-19 (2019), who unlike you will not have benefited from "new Peri-Operative Geriatric Units" care.
* Prospective group: inclusion of patients scheduled to undergo one of the 9 procedures targeted by the "new Peri-Operative Geriatric Units" trial (colectomy, cholecystectomy, , transurethral prostatectomy, transurethral or transcutaneous procedure for non-lithiasis conditions, kidney and ureter procedure and major bladder surgery for tumor condition esophageal, gastric and duodenal procedure for malignancy, transurethral bladder resection)
* Retrospective group: inclusion of patients who were operated in 2019
This study will assess whether "Peri-Operative Geriatric Units" for digestive or urinary surgery is beneficial for :
* Medical follow-up in the 10 days following the operation and up to discharge (simple follow-up, complications, return to the operating room, etc.),
* Patient outcomes in the 3 months following surgery (discharge date, geriatric assessment, rehospitalization, other significant medical events, etc.).
These data will be compared with those of patients operated on in the reference year prior to pandemic Covid-19 (2019), who unlike you will not have benefited from "new Peri-Operative Geriatric Units" care.
Study Oversight
Has Oversight DMC:
True
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?: