This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
100
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.
Jyvaskyla Central Hospital
Jyväskylä, Finland
Oulu University Hospital
Oulu, Finland
Seinajoki Central Hospital
Seinäjoki, Finland
Tampere University Hospital
Tampere, Finland
Surgical site infection
The incidence of surgical site infections at 30 days follow up
Time frame: 30 days
Incisional hernia
Incidence of incisional hernia
Time frame: 10 months
Complications classified by Clavien-Dindo classification
Clavien-Dindo I-V complications at 30 days follow-up
Time frame: 30 days
Re-operation rate
Demand for re-operations related to mesh or complications
Time frame: 5 years
Operative time
Time (min) needed for operation and application of mesh/implant
Time frame: 30 days
Length of stay
Length of stay at the hospital after the operation
Time frame: 30 days
Quality of life measured by RAND-36 survey
Quality of life after the operation measured by RAND 36
Time frame: 5 years
Incidence of hernia
Incidence of incisional hernia
Time frame: 5 years
Cost analysis
Analysis of costs to both individual and community
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.