Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorOdense University Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Vacuum assisted closure

    Procedure/Surgery

    The 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/Surgery

    Abdomen 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

340 Participants
are divided into 2 treatment groups
Group A: Vacuum assisted closureActive comparator 1 intervention
Group B: Relaparotomy "on-demand"Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 year

Secondary outcomes

1

Mortality at 30, 90 days and 1 year

Mortality

Time frame
1 year
2

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.

Time frame
3 and 12 months
3

Ventral hernia rate

Ventral hernia after after 12 months assessed by clinical examination and abdominal CT-scan with intravenous contrast +/- Valsalva maneuvre.

Time frame
3 and 12 months
4

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

Time frame
Up to 12 weeks

Other outcomes

1

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

Time frame
First 4 days afte index laparatomy
2

Inscional hernia

Incisional hernia rate after three years assessed by a retrospective review of patient records

Time frame
3 years

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