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

Perforated Diverticulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04427891
• Other study ID #: 2019-06114
• Status: Recruiting
• Start date: September 21, 2021
• Est. completion date: December 2026

Study information

• Verified date: December 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Eva Haglind, MD, PhD
• Phone: +46705349088
• Email: eva.haglind[@]vgregion.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2026
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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• Withdrawn consent (any group)

Related Conditions & MeSH terms

• Diverticulitis
• Perforated Diverticulitis
• Peritonitis

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital/Östra	Gothenburg	Västra Götaland Region

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory response	determination of levels of 92 proteins in abdominal fluid and blood	index surgery (Groups I and II)/ emergency room (Group III)
Secondary	inflammatory response in tissue	RNA sequencing (96 spcific genes) in abdominal tissue	index surgery (Groups I and II)/ emergency room (Group III)
Secondary	microbiota composition	PCR amplification, cloning and sequencing of genes	index surgery (Groups I and II)/ emergency room (Group III)