Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286124
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-29
First Post:
2023-12-15
Brief Title:
Midline Restoration After HYbriD Hernia RepAir Surgery HYDRA
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Midline Restoration After HYbriD Incisional Hernia RepAir HYDRA With the SymbotexTM Mesh
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
HYDRA
Brief Summary:
The goal of this observational study is to learn about the functioning of the abdominal wall in patients who underwent hybrid open- and laparoscopic incisional hernia repair The main objective is to assess the anatomical restoration and function of the linea alba one year after surgery by ultrasonography and mean peak torque during trunk flexion using a BioDex machine
Detailed Description:
Rationale Abdominal wall functioning has been reported to be higher in patients that underwent open incisional hernia repair compared to laparoscopic incisional hernia repair With the use of a recently developed hybrid approach we aim for a functional anatomical restoration of the linea alba while also achieving the technical advantages of the hybrid approach
Objective The main objective is to asses functional anatomical restoration of the linea alba through functioning in mean peak torque and ultrasound examination
Study design Multicentre prospective cohort study Study population Adult patients with a midline incisional hernia 4 cm and 10 cm
Intervention Not applicable Main study parametersendpoints The primary objective of this study is to assess anatomical restoration and function of the linea alba one year after surgery by ultrasonography and measuring the mean peak torque during trunk flexion using a BioDextrademark machine
Nature and extent of the burden and risks associated with participation benefit and group relatedness No risk is associated with participation other than known complications for incisional hernia repair HYDRA is part of standard care in the Alrijne Hospital and the technique has previously been published The mesh used in this study is being used on a world-wide scale We do not expect additional risks with this study As participants have to visit the Erasmus Medical Center Erasmus MC an additional three times and have to fill in additional questionnaires there is a burden for enrolled patients
Objective The main objective is to asses functional anatomical restoration of the linea alba through functioning in mean peak torque and ultrasound examination
Study design Multicentre prospective cohort study Study population Adult patients with a midline incisional hernia 4 cm and 10 cm
Intervention Not applicable Main study parametersendpoints The primary objective of this study is to assess anatomical restoration and function of the linea alba one year after surgery by ultrasonography and measuring the mean peak torque during trunk flexion using a BioDextrademark machine
Nature and extent of the burden and risks associated with participation benefit and group relatedness No risk is associated with participation other than known complications for incisional hernia repair HYDRA is part of standard care in the Alrijne Hospital and the technique has previously been published The mesh used in this study is being used on a world-wide scale We do not expect additional risks with this study As participants have to visit the Erasmus Medical Center Erasmus MC an additional three times and have to fill in additional questionnaires there is a burden for enrolled patients
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