Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery

NCT02726932 | Completed

• 1 other identifier: Dnro 6/13/03/02/2016
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 1

Brief 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. Additionally, a variety of inflammatory markers from blood samples will be collected in order to analyze their correlation with patient outcomes.

Conditions

Peritonitis

Keywords

Peritonitis; Inflammatory Markers; Patient Outcome Assessment; Classification; Multiple Organ Failure; Intraabdominal Infections

Outcome Measures

Primary Outcomes (5)

• Mortality

  Death within 90 days of primary operation for diffuse peritonitis

  90 days

• ICU admission

  Intensive Care Unit admission and length of ICU treatment

  90 days

• Length of hospitalization

  Days in hospital postoperatively

  90 days

• Reoperations

  Reoperations needed postoperatively

  90 days

• Complications

  Postoperative complications according to Clavien-Dindo classification

  90 days

Interventions

No intervention, merely observational OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients operated for complicated intra-abdominal infection in a single university hospital.

You may qualify if:

• adult patients \> 18 years old
• operated for complicated intra-abdominal infection

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Related Publications (1)

• 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.

  PMID: 30976292 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sample

MeSH Terms

Conditions

Peritonitis; Multiple Organ Failure; Intraabdominal Infections

Condition Hierarchy (Ancestors)

Infections; Peritoneal Diseases; Digestive System Diseases; Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Panu Mentula, M.D., Ph.D.

  Helsinki University Central Hospital, Abdominal Center, Gastrointestinal Surgery

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 4, 2016
• Study Start: March 30, 2016
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)