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

December 23, 2022 updated by: Eva Haglind, MD, PhD, professor, Sahlgrenska University Hospital, Sweden

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

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.

Study Overview

Status

Recruiting

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Västra Götaland Region
      • Gothenburg, Västra Götaland Region, Sweden, SE 416 85
        • Recruiting
        • Sahlgrenska University Hospital/Östra
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
index surgery (Groups I and II)/ emergency room (Group III)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammatory response in tissue
Time Frame: index surgery (Groups I and II)/ emergency room (Group III)
RNA sequencing (96 spcific genes) in abdominal tissue
index surgery (Groups I and II)/ emergency room (Group III)
microbiota composition
Time Frame: index surgery (Groups I and II)/ emergency room (Group III)
PCR amplification, cloning and sequencing of genes
index surgery (Groups I and II)/ emergency room (Group III)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Eva Haglind, MD,PhD, Sahlgrenska univesitetssjukhuset

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

December 27, 2022

Last Update Submitted That Met QC Criteria

December 23, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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