To evaluate the efficacy of the use of swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure against incisional hernia in patients operated in urgency/emergency setting in contaminated/infected fields with peritonitis. The aim of the study is to reduce the incidence of incisional hernia from 50% to 20%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
90
The mesh placement will be preceded by the plane preparation. The subcutaneous tissue will be dissociated from the anterior rectum-muscles fascia. The retro-muscular rectum muscles plane will be dissected preparing a 5-6 cm pouch necessary to the prosthesis positioning. The mesh will be fixed with at least 8 long-lasting absorbable transfix stitched. The prosthesis will be placed with at least a 5 cm overlap. If the peritoneal plane can be sutured a Jackson-Pratt 10 suction drain will be placed under the prosthesis. A Jackson-Pratt 10 suction drain will always be placed over the prosthesis. Anterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. Another Jackson-Pratt 10 suction drain will be placed over the anterior fascia if the subcutaneous tissue is thick. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane.
Anterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane.
Papa Giovanni XXIII hospital
Bergamo, Italy
RECRUITINGIncisional hernia rate
Time frame: 3 months
Incisional hernia rate
Time frame: 6 months
Incisional hernia rate
Time frame: 12 months
Incisional hernia rate
Time frame: 24 months
Morbidity
Time frame: 0 months
Morbidity
Time frame: 3 months
Morbidity
Time frame: 6 months
Morbidity
Time frame: 12 months
Morbidity
Time frame: 24 months
Length of surgery
Time frame: Day 0
Time to drain removal
Time frame: participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks
Length of stay in hospital
Time frame: At the discharge, an expected average of 1-2 weeks after the intervention
Mortality
Time frame: 0 months
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Mortality
Time frame: 3 months
Mortality
Time frame: 6 months
Mortality
Time frame: 12 months
Mortality
Time frame: 24 months