Complement Diagnosis of Acute Appendicitis

NCT03450642 | Completed

• 1 other identifier: 1112/131544
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Acute appendicitis is a common condition requiring urgent surgery but is often difficult to distinguish from other non-surgical conditions such as urinary infections, pelvic inflammatory disease and non-specific abdominal pain. Delay in diagnosis can result in significant morbidity and potential mortality. Currently, there is no one diagnostic test available and raised inflammatory markers such as C-reactive protein (CRP) and White Blood Count (WBC) along with an evolving clinical picture, help guide management. However, these markers are slow to respond to inflammation and are non-specific for appendicitis. The Complement cascade is an immune response to inflammation and infection involving three pathways which activate a number of proteins in the blood. Monitoring the absolute levels of these proteins should provide a faster and differential diagnostic test. The investigators propose a pilot trial to measure concentrations of Complement cascade activation biomarkers in the blood during hospital admissions for acute right lower abdominal pain, a symptom of appendicitis. Further, analysis of the differential Complement cascade pathway activation could potentially identify underlying pathology allowing the clinicians to target therapies.

Conditions

Acute Appendicitis

Outcome Measures

Primary Outcomes (1)

• Complement Activation differential diagnosis of Acute Appendicitis in a patient cohort presenting with Right Iliac Fosse Pain

  C3 and C4 plasma concentration were measured in units of g/L over the time course t= admission, 4,8,12,23,47,71 hours or until discharge. Activation measures were derived as C3 and C4 differences at time each time point compared with admission values to derive changes in concentration which were compared in patients with a positive pathology diagnosis of the excised appendix (AA Group) and patients with a negative pathology diagnosis of the excised appendix or those patients discharged without appendectomy (non-AA Group).

  up to 5 days

Secondary Outcomes (6)

• clinical Alvarado Score

  up to 5 days

• The clinical Alvarado Score modified to include CRP > 5 mg/L - score 1

  up to 5 days

• Complement Activation Derived from C3dg

  up to 5 days

• Complement Activation Terminal Cascade Complex

  up to 5 days

• Complement Activation C3a in Urine

  up to 5 days

Study Arms (1)

Observation

Patients presenting with right Iliac Fosse pain

Other: Observational

Interventions

Observational OTHER

Complement cascade components C3, C4, iC3b and TCC serum concentrations were measured over the time course from t= admission, 4,8,12,23,47,71 hours or until discharge.

Observation

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

70 patients presenting with right Iliac Fosse pain

You may qualify if:

• Admission for right iliac fossa pain

You may not qualify if:

• Under 18 years unwilling to provide informed consent pregnant women diabetic immunosuppressed immunosuppression or steroid treatment within last 12 months learning disability Non-english speakers

Sponsors & Collaborators

• University of Exeter: lead
• Royal Devon and Exeter NHS Foundation Trust: collaborator

Study Sites (1)

Royal Devon & Exeter Foundation NHS Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Andrew M Shaw, PhD

  University of Exeter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2015
• First Posted: March 1, 2018
• Study Start: January 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 1, 2018

Record last verified: 2018-02

Locations

GB (1)