Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611462
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-02-13
Brief Title:
STRONG for Surgery Strong for Life - Intensive Prehabilitation for Risk Reduction in Ventral Hernia Repair
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Tailored Intensive Prehabilitation for Risky Lifestyles Before Ventral Hernia Repair on Postoperative Outcomes Health and Costs - a Randomised Controlled Trial STRONG-Hernia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRONG-Hernia
Brief Summary:
The five risky lifestyles Smoking Nutrition obesity and malnutrition risky Alcohol intake and Physical inactivity SNAP are common in surgical patients and associated with worse postoperative outcomes Mono-factor interventions targeting and improving these risky lifestyles have been shown to reduce the risk at surgery but there is a lack of systematic assessment of all five lifestyles of the patient before surgery and related optimization
This study aims to evaluate the effect of intensive combined lifestyle interventions the STRONG programme compared with treatment as usual in patients undergoing ventral hernia repair on postoperative complications health and costs on short and longer term
The hypothesis is that the STRONG programme will halve the complication rates within 30 days
This study aims to evaluate the effect of intensive combined lifestyle interventions the STRONG programme compared with treatment as usual in patients undergoing ventral hernia repair on postoperative complications health and costs on short and longer term
The hypothesis is that the STRONG programme will halve the complication rates within 30 days
Detailed Description:
This study is a multicentre randomised controlled trial A total of 400 participants with one or more of the five risky SNAP lifestyles will be randomised to either the STRONG programme a prehabilitation intervention or treatment as usual preoperatively control The STRONG programme is individually tailored to the needs of the participants The program contains education motivational and pharmaceutical support All participants will be followed up at the end of the interventionat surgery one three and six months after surgery Long-term outcomes are followed up from national registers two years after surgery
Interim analysis will be employed
Interim analysis will be employed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None