Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404489
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-04-24
Brief Title:
Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery PROGRESS
Sponsor:
Università Vita-Salute San Raffaele
Organization:
Università Vita-Salute San Raffaele
Study Overview
Official Title:
Evaluation of a Multimodal Program of Prehabilitation in Oncological Patients Undergoing Major Gastrointestinal Surgery Within an ERAS Pathway
Status:
RECRUITING
Status Verified Date:
2024-05
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:
PROGRESS
Brief Summary:
The importance of postoperative rehabilitation on physical performance and recovery is well-recognized However the preoperative period constitutes a unique opportunity to address comorbidities and modifiable risk factors improve functional capacity and address deficiencies in physiologic reserve which might otherwise preclude surgery or significantly impede recovery
Therefore the aim of this study is to evaluate the efficacy of a multimodal program of prehabilitation in patients undergoing major oncological gastrointestinal surgery The hypothesis is that severe post-operative complications within 30 days will be reduced in the treatment group compared to the control group
Therefore the aim of this study is to evaluate the efficacy of a multimodal program of prehabilitation in patients undergoing major oncological gastrointestinal surgery The hypothesis is that severe post-operative complications within 30 days will be reduced in the treatment group compared to the control group
Detailed Description:
This is a 2-arm randomized multicentric controlled trial to test the efficacy of a personalized multidisciplinary preoperative conditioning program to reduce severe complications and facilitate recovery in patients undergoing major oncological gastrointestinal surgery
400 patients will be randomized ratio 11 and allocated either to the intervention group Prehabilitation or to the control group which will be treated according to usual standard of care within Enhanced Recovery After Surgery ERAS pathways
Multimodal prehabilitation is a preoperative intervention which includes exercise training nutritional therapy and anxiety reducing techniques aimed at preventing or attenuating surgery-driven functional decline
The primary objective is to evaluate the effect of a multimodal program of prehabilitation on postoperative severe complications
Secondary outcomes include time to functional recovery length of hospital stay complication severity proportion of patients returning to preoperative functional walking capacity and self-reported activity status and generic health related quality of life at 30 days after surgery
Included patients will be randomized and allocated either to the intervention group which will receive 4 weeks of prehabilitation or to the control group which will receive no prehabilitation All patients will be reassessed the day before surgery 30 days and 3 months after surgery
Patients enrolled in treatment group will not receive any additional medication but only a multimodal program to optimize their preoperative functional capacity
Within 30 days prior to scheduled surgery participants of both groups will undergo a specialized multidisciplinary assessment with a physician a certified physiotherapist registered dietitian and psychology trained personnel All tests will be performed following international guidelines and standardized verbal instructions A tailored intervention will be prescribed if specific physical nutritional or psychological impairments will be identified during the assessment phase Based on the data obtained during the multimodal assessment different domains and levels of care will be prescribed focusing on exercise training andor nutrition optimization andor distress-coping techniques Different combinations of three domains will be utilized to maximize their synergistic anabolic effect
Statistical analysis will be performed according to study sites type of surgery esophageal gastric colonic rectal and neoadjuvant treatment
400 patients will be randomized ratio 11 and allocated either to the intervention group Prehabilitation or to the control group which will be treated according to usual standard of care within Enhanced Recovery After Surgery ERAS pathways
Multimodal prehabilitation is a preoperative intervention which includes exercise training nutritional therapy and anxiety reducing techniques aimed at preventing or attenuating surgery-driven functional decline
The primary objective is to evaluate the effect of a multimodal program of prehabilitation on postoperative severe complications
Secondary outcomes include time to functional recovery length of hospital stay complication severity proportion of patients returning to preoperative functional walking capacity and self-reported activity status and generic health related quality of life at 30 days after surgery
Included patients will be randomized and allocated either to the intervention group which will receive 4 weeks of prehabilitation or to the control group which will receive no prehabilitation All patients will be reassessed the day before surgery 30 days and 3 months after surgery
Patients enrolled in treatment group will not receive any additional medication but only a multimodal program to optimize their preoperative functional capacity
Within 30 days prior to scheduled surgery participants of both groups will undergo a specialized multidisciplinary assessment with a physician a certified physiotherapist registered dietitian and psychology trained personnel All tests will be performed following international guidelines and standardized verbal instructions A tailored intervention will be prescribed if specific physical nutritional or psychological impairments will be identified during the assessment phase Based on the data obtained during the multimodal assessment different domains and levels of care will be prescribed focusing on exercise training andor nutrition optimization andor distress-coping techniques Different combinations of three domains will be utilized to maximize their synergistic anabolic effect
Statistical analysis will be performed according to study sites type of surgery esophageal gastric colonic rectal and neoadjuvant treatment
Study Oversight
Has Oversight DMC:
None
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?:
None