Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis: A Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis to either vacuum assisted closure or relaparotomy on-demand.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Denmark
Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Pooya Rajabaleyan, M.D.
pooya.r@hotmail.com
+4527118889
Backup
Mark Ellebæk, M.D., Ph.d.
markep01@gmail.com
+4540880511
Time Frame
Start Date: 2020-06-01
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 340
Treatments
Active_comparator: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital