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

NCT04427891 | Active Not Recruiting

• 1 other identifier: 2019-06114
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perforated Diverticulitis

Keywords

perforated diverticulitis; peritonitis; protein changes; microbiota

Outcome Measures

Primary Outcomes (1)

• inflammatory response

  determination of levels of 92 proteins in abdominal fluid and blood

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

Secondary Outcomes (2)

• inflammatory response in tissue

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

• microbiota composition

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

Study Arms (3)

Group I

Patients undergoing emergency surgery due to perforated diverticulitis with peritonitis. No intervention, samples from abdominal fluid, blood, tissue, feces

Group II

Patients with colorectal cancer undergoing elective surgery. No intervention. Samples as for Group I

Group III

Patients with mild diverticulitis, not undergoing surgery. No intervention. Samples from blood and feces.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The aim is to study immune responses in patients with perforated divrticulitis leading to peritonitis and emergency surgery. This group will be compared with patients operated for colorectal cancer and patients with uncomplicated (mild) diverticulitis not undergoing surgery.

You may qualify if:

• 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)

You may not qualify if:

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• Withdrawn consent (any group)

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Göteborg University: collaborator

Study Sites (1)

Sahlgrenska University Hospital/Östra

Gothenburg, Västra Götaland County, SE 416 85, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

periferal blood, abdominal fluid, colon wall, feces

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Study Officials

• Eva Haglind, MD,PhD

  Sahlgrenska univesitetssjukhuset

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 11, 2020
• Study Start: September 21, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)