- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04427891
Characteristics of Abdominal Fluid in Patients With Diverticulitis Hinchey III or IV
Study of Changes in Abdominal Fluid in Connection With Peritonitis. A Descriptive Study in Patients With Purulent or Fecal Peritonitis.
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Eva Haglind, MD, PhD
- Phone Number: +46705349088
- Email: eva.haglind@vgregion.se
Study Contact Backup
- Name: Anette Wedin
- Phone Number: +46700651143
- Email: anette.wedin@vgregion.se
Study Locations
-
-
Västra Götaland Region
-
Gothenburg, Västra Götaland Region, Sweden, SE 416 85
- Recruiting
- Sahlgrenska University Hospital/Östra
-
Contact:
- Eva Haglind, MD, PhD
- Phone Number: +46705349088
- Email: eva.haglind@vgregion.se
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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- Withdrawn consent (any group)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
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
Collaborators
Investigators
- Principal Investigator: Eva Haglind, MD,PhD, Sahlgrenska univesitetssjukhuset
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-06114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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