Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533839
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Prevention of Parastomal Hernias With a Preformed Three-dimensional Funnel-shaped Mesh
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prevention of Parastomal Hernias With a Preformed Three-dimensional Funnel-shaped Mesh A Prospective Multicenter and Randomized Study PREVEMAC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
PREVEMAC
Brief Summary:
Parastomal hernia PH remains a significant complication following stoma creation boasting a considerable prevalence in the range of 30 to 50 within the first year post-surgery a figure that climbs even higher when considering radiological evidence irrespective of clinical symptoms A noteworthy one-third of these cases necessitate subsequent surgical interventions yielding suboptimal outcomes both in the short and long term The clinical manifestations of PH are diverse ranging from mild inconveniences like fecal leakage and dermatitis to more severe and potentially life-threatening complications such as intestinal obstruction hernia incarceration and ischemia
Various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches yet none offer ideal outcomes
The aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional funnel-shaped mesh
Various systematic reviews and meta-analyses have advocated for the adoption of prophylactic meshes although defining precise incidence and recurrence rates has proven challenging due to methodological disparities across studies Keyhole and modified Sugarbaker techniques dominate laparoscopic and robotic approaches yet none offer ideal outcomes
The aim of this study is to evaluate the decrease of postoperative parastomal hernia using this three-dimensional funnel-shaped mesh
Detailed Description:
None
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