Perforated DiverticulitisNCT04427891
Characteristics of Abdominal Fluid in Patients With Diverticulitis Hinchey III or IV
An observational study of Perforated Diverticulitis, run by Sahlgrenska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Perforated Diverticulitis
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 21 Sep 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- No surgery performed (Group I and III)
- Withdrawn consent (any group)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital/Östra
Gothenburg, Västra Götaland County, SE 416 85
About this study
Official title: 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.
Read the 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.
- Conditions
- Perforated Diverticulitis
- Keywords
- perforated diverticulitis, peritonitis, protein changes, microbiota
- Medical subject headings
- Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
inflammatory response
determination of levels of 92 proteins in abdominal fluid and blood
Measured: index surgery (Groups I and II)/ emergency room (Group III)
Secondary outcomes (2)
inflammatory response in tissue
RNA sequencing (96 spcific genes) in abdominal tissue
Measured: index surgery (Groups I and II)/ emergency room (Group III)
microbiota composition
PCR amplification, cloning and sequencing of genes
Measured: index surgery (Groups I and II)/ emergency room (Group III)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start21 Sep 2021
- Primary completionJun 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perforated DiverticulitisStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Eva Haglind, MD, PhD, professor, Sahlgrenska University Hospital
- Investigators
- Eva Haglind, MD,PhD, Principal investigator, Sahlgrenska univesitetssjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427891
- Sponsor's protocol ID
- 2019-06114
- Other IDs
- 2019
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2020
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Changes in Abdominal Fluid in Connection With Peritonitis. A Descriptive Study in Patients With Purulent or Fecal Peritonitis.
- ClinicalTrials.gov ID
- NCT04427891
- Acronym / sponsor ID
- 2019-06114
- Conditions
- Perforated Diverticulitis
- Keywords
- perforated diverticulitis, peritonitis, protein changes, microbiota
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- No surgery performed (Group I and III)
- Withdrawn consent (any group)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
inflammatory response in tissue
Time frame: index surgery (Groups I and II)/ emergency room (Group III)
microbiota composition
Time frame: index surgery (Groups I and II)/ emergency room (Group III)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Haglind, MD,PhD principal investigator
Sahlgrenska univesitetssjukhuset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perforated Diverticulitis, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
inflammatory response (time frame: index surgery (Groups I and II)/ emergency room (Group III)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.