Characteristics of Abdominal Fluid in Patients With Diver... | NCT04427891

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

NCT04427891

Sponsor

Sahlgrenska University Hospital

Status

Active, not recruiting

Last Update Posted

Apr 27, 2026Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Perforated Diverticulitis

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2021Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Jun 5, 2020

First Submission Date that Met QC Criteria

Jun 9, 2020

First Posted Date

Jun 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2026

Last Update Posted Date

Apr 27, 2026Actual

Name	Class
Göteborg University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Haglind, MD,PhD	Sahlgrenska univesitetssjukhuset	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sahlgrenska University Hospital/Östra		Gothenburg	Västra Götaland County	SE 416 85	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010538	Peritonitis

Ancestor Terms

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D010532	Peritoneal Diseases
D004066	Digestive System Diseases

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