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NCT Number: NCT04427891

Characteristics of Abdominal Fluid in Patients With Diverticulitis Hinchey III or IV

Perforated diverticulitis of the colon can be complicated by peritonitis, either purulent or fecal. Both are life threatening conditions requiring emergency surgery. The background in terms of reasons for inflammation (diverticulitis) and perforation to develop is unknown. In this study we focus on specific changes associated with inflammation, both in tissues and of fecal and mucosal microbiota.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Perforated Diverticulitis Digestive System Diseases Infections Intraabdominal Infections Peritoneal Diseases Peritonitis

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital/Östra

Gothenburg, Västra Götaland County, SE 416 85, Sweden

About this study

A prospective study of abdominal fluid, periferal blood, tissues as well as feces in Patients (perforated diverticulitis with peritonitis undergoing emergency surgery, Group I), and in Controls (patients operated due to colorectal cancer, Group II; patients with mild diverticulitis not needing surgery, Group III).

Immune acitvity in abdominal fluid and periferal blood by immunoassay of 92 individual proteins. mRNA expression of 96 specific genes in tissue samples. Quatification of bacterial diversity in feces and colon mucosa.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signs of perforated diverticulitis with peritonitis and decision to perform emergency surgery (Group I)
  • Signs of acute diverticulitis and no decision of emergency surgery (Group II)
  • Patients with colorectal cancer planned for elective surgery (Group III)

Exclusion criteria

  • No surgery performed (Group I and III)
  • Withdrawn consent (any group)

Treatment and study plan

Primary outcomes

  1. inflammatory response

    Time frame: index surgery (Groups I and II)/ emergency room (Group III)

    determination of levels of 92 proteins in abdominal fluid and blood

Secondary outcomes

  1. inflammatory response in tissue

    Time frame: index surgery (Groups I and II)/ emergency room (Group III)

    RNA sequencing (96 spcific genes) in abdominal tissue

  2. microbiota composition

    Time frame: index surgery (Groups I and II)/ emergency room (Group III)

    PCR amplification, cloning and sequencing of genes

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • Göteborg University

Registry information

Official study title

Study of Changes in Abdominal Fluid in Connection With Peritonitis. A Descriptive Study in Patients With Purulent or Fecal Peritonitis.

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jun 11, 2020
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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