PeritonitisPERICLASSNCT02726932
Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery
An observational study of Peritonitis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to analyze the correlation between intra-abdominal view and patient recovery in secondary peritonitis, and to create a new classification based on these results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonitis
- How many people
- 283 participants
- Where
- 1 siteFinland
- Study dates
- 30 Mar 2016to 30 Mar 2018
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients operated for complicated intra-abdominal infection in a single university hospital.
Who may be able to join
- adult patients > 18 years old
- operated for complicated intra-abdominal infection
Who cannot join
- another diagnosis requiring ICU level care at the same time
- acute pancreatitis
- acute mesenteric ischaemia due to occlusion in superior mesenteric artery or vein
- peritonitis due to timely diagnosed trauma
- missing informed consent or inability to understand it
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to analyze the correlation between intra-abdominal view and patient recovery in secondary peritonitis, and to create a new classification based on these results. Additionally, a variety of inflammatory markers from blood samples will be collected in order to analyze their correlation with patient outcomes.
- Conditions
- Peritonitis
- Being tested
- No intervention, merely observational
- Keywords
- Peritonitis, Inflammatory Markers, Patient Outcome Assessment, Classification, Multiple Organ Failure, Intraabdominal Infections
- Medical subject headings
- Peritonitis, Multiple Organ Failure, Intraabdominal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, merely observationalOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death within 90 days of primary operation for diffuse peritonitis
Measured: 90 days
ICU admission
Intensive Care Unit admission and length of ICU treatment
Measured: 90 days
Length of hospitalization
Days in hospital postoperatively
Measured: 90 days
Reoperations
Reoperations needed postoperatively
Measured: 90 days
Complications
Postoperative complications according to Clavien-Dindo classification
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start30 Mar 2016
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeritonitisStudies of the same condition, open and under way.
- More trials run by Helsinki University Central 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 283 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matti Tolonen, Helsinki University Central Hospital
- Investigators
- Panu Mentula, M.D., Ph.D., Study chair, Helsinki University Central Hospital, Abdominal Center, Gastrointestinal Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726932
- Sponsor's protocol ID
- Dnro 6/13/03/02/2016
- Acronym
- PERICLASS
- Status last verified
- Jan 2019
- First submitted
- 29 Mar 2016
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tolonen M, Sallinen V, Leppaniemi A, Backlund M, Mentula P. The role of the intra-abdominal view in complicated intra-abdominal infections. World J Emerg Surg. 2019 Mar 29;14:15. doi: 10.1186/s13017-019-0232-7. eCollection 2019.
PubMed 30976292
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery
- ClinicalTrials.gov ID
- NCT02726932
- Acronym / sponsor ID
- PERICLASS / Dnro 6/13/03/02/2016
- Conditions
- Peritonitis
- Keywords
- Peritonitis, Inflammatory Markers, Patient Outcome Assessment, Classification, Multiple Organ Failure, Intraabdominal Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 4 Apr 2016 (estimated)
- 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.
The purpose of this study is to analyze the correlation between intra-abdominal view and patient recovery in secondary peritonitis, and to create a new classification based on these results. Additionally, a variety of inflammatory markers from blood samples will be collected in order to analyze their correlation with patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients operated for complicated intra-abdominal infection in a single university hospital.
Key inclusion criteria (2 listed)
- adult patients > 18 years old
- operated for complicated intra-abdominal infection
Key exclusion criteria (5 listed)
- another diagnosis requiring ICU level care at the same time
- acute pancreatitis
- acute mesenteric ischaemia due to occlusion in superior mesenteric artery or vein
- peritonitis due to timely diagnosed trauma
- missing informed consent or inability to understand it
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, merely observational | Other | – |
Primary outcome
Mortality
Time frame: 90 days
Death within 90 days of primary operation for diffuse peritonitis
ICU admission
Time frame: 90 days
Intensive Care Unit admission and length of ICU treatment
Length of hospitalization
Time frame: 90 days
Days in hospital postoperatively
Reoperations
Time frame: 90 days
Reoperations needed postoperatively
Complications
Time frame: 90 days
Postoperative complications according to Clavien-Dindo classification
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Derived from this study: PubMed 30976292Tolonen M, Sallinen V, Leppaniemi A, Backlund M, Mentula P. The role of the intra-abdominal view in complicated intra-abdominal infections. World J Emerg Surg. 2019 Mar 29;14:15. doi: 10.1186/s13017-019-0232-7. eCollection 2019.
- Individual participant dataSharing planned: No
Related trials for Peritonitis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
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RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
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Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
Recruiting
Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis
Fecal Peritonitis, Secondary Peritonitis
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.
Panu Mentula, M.D., Ph.D. study chair
Helsinki University Central Hospital, Abdominal Center, Gastrointestinal Surgery
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 Peritonitis, run by Helsinki University Central Hospital at 1 site in Finland.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 16 Jan 2019. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality (time frame: 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02726932, which also lists 1 linked publication.
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 16 Jan 2019.