Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251583
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-02-01
Brief Title:
Prevention of Incisional Hernia With Mesh-suture at Umbilical Trocar Site
Sponsor:
Miguel A ngel Garci-a Urena
Organization:
Henares University Hospital
Study Overview
Official Title:
Prevention of Incisional Hernia With Mesh-suture Duramesh Suture at Umbilical Trocar Site in Patients Who Undergo Laparoscopic Surgical Approach
Status:
RECRUITING
Status Verified Date:
2024-02
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:
INDURATE
Brief Summary:
Incisional hernia related to the umbilical trocar site is probably the most frequent complication after laparoscopic surgical procedures However this is an underestimated sequelae of laparoscopic surgery which may involve an important morbidity and an increase in healthcare costs
The incidence of incisional trocar site hernia ranges from 20 to 35 of patients after laparoscopic surgery depending on the different investigations Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients In that sense suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias
INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures
The incidence of incisional trocar site hernia ranges from 20 to 35 of patients after laparoscopic surgery depending on the different investigations Prophylactic meshes have been tried in an attempt to reduce the incidence of this complication in obese patients In that sense suture-meshes can be an alternative to conventional meshes to improve the incidence of incisional hernias
INDURATE TRIAL aims to test if suture-mesh is capable of reducing the incidence of incisional hernia in patients with risk factors for the development of this frequent complication when compared with conventional monofilament sutures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None