Parietene Macro
DeviceParietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
NCT Number: NCT03445936
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Jyvaskyla Central Hospital, Jyväskylä, Finland
Incisional hernia after loop-ileostomy closure may be an underestimated problem. Research on both biological and synthetic mesh in this context is scarce and no randomized controlled trials comparing meshes exist.
The aim of this study is to compare Parietene Macro and Permacol in prevention of incisional site hernia after temporary loop-ileostomy reversal after anterior resection and TME for rectal cancer.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
Time frame: 30 days
The incidence of surgical site infections at 30 days follow up
Time frame: 10 months
Incidence of incisional hernia
Time frame: 30 days
Clavien-Dindo I-V complications at 30 days follow-up
Time frame: 5 years
Demand for re-operations related to mesh or complications
Time frame: 30 days
Time (min) needed for operation and application of mesh/implant
Time frame: 30 days
Length of stay at the hospital after the operation
Time frame: 5 years
Quality of life after the operation measured by RAND 36
Time frame: 5 years
Incidence of incisional hernia
Time frame: 5 years
Analysis of costs to both individual and community
University of Oulu
Other
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