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

Launched by ODENSE UNIVERSITY HOSPITAL · Apr 26, 2019

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of treating patients with fecal or diffuse peritonitis, which is a serious infection in the abdominal cavity caused by a perforation or hole in the intestines. The trial compares using a vacuum-assisted closure, which helps to heal the wound and prevent infection, against a traditional surgery called “on-demand relaparotomy,” where doctors may reopen the abdomen if needed. This study aims to see which method is more effective for patients facing this condition.

To be eligible for the trial, participants need to be adults aged 18 and older who are scheduled for surgery due to suspected peritonitis linked to a perforation in the small bowel, colon, or rectum. They must have evidence of infection in at least two areas of the abdomen. However, people with certain conditions, such as those with different types of peritonitis or those who are pregnant, cannot take part in the trial. If someone joins, they can expect close monitoring and care throughout the treatment process, helping researchers learn more about the best ways to manage this severe infection.

Gender

ALL

Eligibility criteria

• 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