C20 Z93.2
Conditions
Interventions
Group 1: Abdominal wall closure during loop ileostomy closure with a continuous slowly absorbable suture reinforced with a retromuscular non-absorbable, macro-pore (pore size >/= 1000 µm or effective
Sponsors
Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Planned elective loop ileostomy closure 2. Adult Patients (= 18 years of age) 3. Life expectancy > 2 years 4. Written informed consent 5. Ability to understand character and individual consequences of the clinical trial
Exclusion criteria
Exclusion criteria: 1. American Society of Anesthesiologists (ASA) physical status class >/= 4 2. Infected/septic surgical site (Risk for Surgical Site Occurrences (SSO) of Grade 4 according to Ventral Hernia Working Group (VHWG)-classification 3. Presence of parastomal hernia in loop ileostomy site with fascia defect > 8cm 4. Presence of a concomitant incisional hernia that impedes loop ileostomy reversal or placement of the mesh at the ileostomy site 5. Patients with prior mesh placement on site of ileostomy 6. Chronic renal failure under haemodialysis/ peritoneal dialysis 7. Patients under strong immunosuppression or other medications likely to impede wound healing as judged by the operating surgeon 8. Congenital haemorrhagic diathesis with need of perioperative treatment 9. Participation in another interventional trial with interference on intervention and primary outcome of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incisional hernia rate within 24 months after intervention as defined by the European Hernia Society | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Postoperative complications within 30 days according to Dindo-Clavien classification (DCC) = 3 • Number of Surgical Site Occurrences (SSO) defined as follows: 2. Superficial or deep surgical site infections (SSI) within 1 year after index operation according to the CDC definition. 3. Rate of wound seromas at former ostomy site within 30 days after index operation. 4. Rate of hematomas at former ostomy site within 30 days after index operation. 5. Enterocutaneous fistulas within 24 months after index operation. 6. Number of patients undergoing incisional hernia repair at site of ileostomy closure within 24 months after index operation. 7. Number of revision surgeries because of complication related to ileostomy closure within 24 months after index operation 8. Chronic postoperative pain in ileostomy closure site measured via the Pain Questions of the EHS-QoL questionnaire at baseline, 12 and 24 months postoperative. 9. Health-related Quality of Life at 12 and 24 months after index operation according to EHS -QoL questionnaire. 10. Hernia Recurrence Inventory (HRI) at 12 and 24 months. | — |
Countries
Germany
Contacts
Public ContactAndré Mihaljevic
Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum Tübingen
Outcome results
None listed