Prophylactic mesh reinforcement of the abdominal wall at the site of temporary ileostomy closure is effective in preventing postoperative incisional hernia. This prospective, multicenter, observational study will evaluate performance of Phasix biosynthetic mesh when used to reinforce fascial closure .
Study Type
OBSERVATIONAL
Enrollment
203
Minimally Invasive General and Oncologic Surgery Unit - Univesity of Naples Federico II
Naples, Italy
RECRUITINGIncisional hernia rate
CT scan or Ultrasound as imaging to detect incisional hernia
Time frame: at 24 months
Early and Long-term Complication Rates
Clavien-Dindo classification
Time frame: after surgery to 24 months
Postoperative pain
Visual analogue scales (VAS) Range: 1-100. Higher score correlates with more pain
Time frame: after surgery to 24 months
Quality of life by Carolinas Comfort Scale (CCS) and Euro-Qol 5D-5L questionnaires
CCS - Range: 0-115. Higher score correlates with worse outcome
Time frame: after surgery to 24 months
Budget Impact Analysis
Healthcare Cost Analysis including direct costs (fixed and variable)
Time frame: after surgery to 24 months
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