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Table 2 Eligibility Criteria

From: A prospective, randomised, controlled, double-blind phase I-II clinical trial on the safety of A-Part® Gel as adhesion prophylaxis after major abdominal surgery versus non-treated group

Inclusion criteria Exclusion criteria
• Patients of both sexes undergoing a primary elective median abdominal incision • Patients with a known history of adhesion or peritonitis
• Age equal or greater than 18 years • Patients with a known sensitivity to polyvinylalcohol or carboxy-methylcellulose
• Written informed consent • Simultaneous participation in another clinical trial with interfering end-points
• Expected incison length ≥15 cm • Emergency surgery
• Expected survival time more than12 months • Patients with peritoneal carcinosis or peritoneal dialysis
• For female adults of reproductive potential: negative pregnancy test at visit 1 and sufficient contraception from time of written consent up to at least 4 months • Patients with systemic immunsuppression (e.g. hydrocortisone >50 mg per daily, other immunsuppressants like Azathropin, Mycophenolatmofetil, Ciclosporin, Everolimus, Methotrexat ect.), chemotherapy or radiotherapy within the last 2 weeks prior surgery
  • Patients with ascites >200 ml
  • ASA > 3
  • Patients with intra-abdominal abscess or other intra-abdominal infection
  • Renal impairment (Creatinine >1.3 mg/ml)
  • Pregnant or breast-feeding women
  • Lack of compliance
  • Surgical procedures or patients which require insertion more than 2 intra abdominal drains