Incisional Hernia
Conditions
Keywords
peritonitis patients
Brief summary
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%.
Interventions
DEVICEBiological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention
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.
PROCEDUREDirect suture of the anterior abdominal wall fascia
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.
Sponsors
A.O. Ospedale Papa Giovanni XXIII
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Patients aged \> 18 years old * Clinical and/or laboratory and/or radiological evidence/signs of peritonitis of any origin (peritoneal reactivity, positive Blumberg sign, fever, free air/fluid in abdominal cavity, leucocytosis, increased CRP (C-reactive protein, lactic dehydrogenase (LDH), tachycardia, tachypnea, clinical or radiological evidence/suspect of bowel ischemia) * Eventual strong suspect of possible bacterial translocation (reduction of the natural intestinal barrier against bacterial translocation, i.e. bowel ischemia, bowel overdistension, intestinal occlusion, etc.) * Surgical indication for midline laparotomy independently from eventual previous laparotomies * Informed consent
Exclusion criteria
* • Patients aged \< 18 years old * Informed consent refusal * No Clinical and/or laboratory and/or radiological evidence/signs of peritonitis of any origin. * Surgical indication for laparotomies other than midline one * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incisional hernia rate | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Morbidity | 0 months |
| Length of surgery | Day 0 |
| Time to drain removal | participants will be followed for the duration of hospital stay, an expected average of 1-2 weeks |
| Length of stay in hospital | At the discharge, an expected average of 1-2 weeks after the intervention |
| Mortality | 0 months |
Countries
Italy
Outcome results
None listed