About this trial
Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis to either vacuum assisted closure or relaparotomy "on-demand".
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Diffuse peritonitis originating from a different focus than the small intestine, colon or rectum
Diffuse peritonitis originating from a perforation on the stomach, duodenum, gallbladder, appendix, necrotizing pancreatitis, salpingitis, or peritoneal dialysis
Primary peritonitis
Immunocompromised (ongoing chemotherapy or prednisolone >20 mg/day)
Trial design
Single group
Treatments tested in this trial
Vacuum assisted closure
Procedure/SurgeryThe Vacuum assisted closure system consists of an abdominal dressing covering the intra abdominal viscera over the dressing there will be placed a blue sponge which will be covered by drape and connected to a vacuum pump.
Relaparotomy "on demand"
Procedure/SurgeryAbdomen is closed at the index operation after source of peritonitis is treated. Every 48-hours the patients are evaluated for the need of relaparotomy based on clinical and paraclinical parameters.
Treatment groups
Trial outcomes
Primary outcomes
Primary endpoint is to compare peritonitis related complications and Comprehensive Complication Index (CCI) between NPWT treatment (VAC) and conventional treatment (ROD) at 30, 90 days and 1 year.
Disease-Related Major Morbidity Needing Readmission and Conservative Treatment but Not Surgery * Fistula * Wound dehiscence/incisional hernia with obstruction * Abscess needing percutaneous drainage * Renal failure * Myocardial infarction * Gastric or duodenal bleeding * Respiratory failure * Urosepsis Disease-Related Major Morbidity Needing Surgical Intervention During First Admission or Readmission * Incisional hernia * Bowel obstruction or herniation due to intra-abdominal adhesions * Burst abdomen * Abdominal compartment syndrome * Fistula * Intra-abdominal bleeding * Intra-abdominal hematoma needing surgical evacuation * Perforation of visceral organ confirmed at surgery * Anastomotic leakage * Ischemia or necrosis of a visceral organ * Enterostomy dysfunction due to prolapse, stenosis, or retraction * Gastric or duodenal ulcer bleeding needing intervention of any type
Secondary outcomes
Mortality at 30, 90 days and 1 year
Mortality
Quality of life after treatment
Quality of life is measured after 3 and 12 months by the short form health survey (SF-36) questionnaire. The scale measures overall health status. SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Following eight sections are included: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health.
Ventral hernia rate
Ventral hernia after after 12 months assessed by clinical examination and abdominal CT-scan with intravenous contrast +/- Valsalva maneuvre.
Hospital care utility within three months after index surgery
Three months after the index operation, a record review will be made to estimate the health care utility and includes surgeries, total hospital stay, admissions at the ICU, and radiological interventions
Other outcomes
Microdialysis
The concentration of lactate, glycerol, pyruvate, glucose, and cytokines in the peritoneal fluid in a subgroup of 10 patients from each group measured by intraperitoneal microdialysis postoperative day 0-4
Inscional hernia
Incisional hernia rate after three years assessed by a retrospective review of patient records
Sponsors and contacts
Click on the lead sponsor to view all of their trials.