Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis: A Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Odense University Hospital
- Enrollment
- 340
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis to either vacuum assisted closure or relaparotomy "on-demand".
Detailed Description
Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis* to either vacuum assisted closure or relaparotomy "on-demand". The aim with our study is to compare the postoperative complications between vacuum assisted closure and relaparotomy "on-demand".
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.
Secondary outcome parameters are: Mortality at 30, 90 days and 1 year, SOFA score and C-reactive protein measured the first seven days after index laparatomy, quality of life after 3 and 12 months (SF-36 questionnaire), ventral hernia after 3 and 12 months. (assessed by CT) and, hospital care utility within three months after index surgery. A power calculation was made which concluded that 340 patients should be included.
*Diffuse fecal peritonitis is defined as contamination of 2 out of the 4 abdominal quadrants with fecal contamination starting from the small intestine, colon or rectum.
Design
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients eligible for enrolment are 18+ years of age and are scheduled for acute laparotomy due to suspected peritonitis originating from perforation of the small bowel, colon, or rectum. To be included, purulent, enteric, or fecal contamination in a minimum of 2 out of 4 quadrants must be confirmed.
Exclusion Criteria
- •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)
- •Chronic parenchymal liver disease
- •Pregnancy
- •Patients with end-stage disease
- •Laparoscopic surgery (not converted to laparotomy)
- •Acute occlusion of superior mesenteric artery
- •Peritoneal carcinomatosis
- •Abdominal trauma
- •Lack of consent from the surgical equipoise
- •Local peritonitis confined to 1 quadrant only
Arms & Interventions
Vacuum assisted closure
The VAC® Abdominal Dressing System (KCI Vacuum Assisted Closure, San Antonio, TX, USA) will be used. Intestines, including lateral aspects, are covered by the visceral protective layer. The first layer of foam is placed in the laparostoma on the visceral protective layer and must extend below the fascia at a distance of 5 cm from the facial opening. Above this, a minimum of one piece of foam is folded and placed in the laparostoma. Finally, the laparostoma will be covered by the occlusive drape. A circular opening of approximately 5 cm in diameter will be created in the drape where the connection tubes to the vacuum pump will be placed. Simultaneously while applying the negative pressure of 125 mmHg, the wound edges are approximated manually towards the midline. Each dressing change must be performed in the operation theatre with the patient in general anesthesia and muscle relaxation.
Intervention: Vacuum assisted closure (Procedure)
Relaparotomy "on-demand"
The Isreaelsson principle includes a running suture of the fascia with a distance of 5 mm between the stitches of 5 mm and the distance to the facial edge of 5-10 mm. Monofilament PDS 2-0 or equivalent is used. The suturing is started cranially and caudally, and the sutures are tied with self-locking knots. Four times as much suture material as the length of the wound must be used. The peritoneal fluid must be cultured at closure.
The treating surgeon decides to perform a ROD and should be guided by the patient's general condition, gastrointestinal function, renal function, and inflammatory parameters at daily rounds.
Intervention: Relaparotomy "on demand" (Procedure)
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.
Time Frame: 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(1 year)
- Quality of life after treatment(3 and 12 months)
- Ventral hernia rate(3 and 12 months)
- Hospital care utility within three months after index surgery(Up to 12 weeks)
Investigators
Pooya Rajabaleyan
Principal investigator
Odense University Hospital