NCT02742402

Brief Summary

The aim of the study is to evaluate whether patients with early equivocal appendicitis can be observed instead of immediate diagnostic imaging. Half of the patients are randomly assigned to observation group, while the other half will undergo diagnostic imaging. The hypothesis is that resolving appendicitis is common in these patients. Thus, in observation group there will be fewer patients with appendicitis diagnosis and observation reduces the use of diagnostic imaging and surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

4 years

First QC Date

April 7, 2016

Last Update Submit

August 24, 2021

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

  • Appendicitis requiring surgery or other intervention

    30 days from randomization

Secondary Outcomes (9)

  • Complicated appendicitis

    30 days from randomization

  • Delayed appendicitis diagnosis

    30 days from randomization

  • Number of diagnostic imaging studies needed

    30 days from randomization and within 1 year after randomization

  • Appendicitis requiring surgery or other intervention

    within 1 year after randomization

  • Negative appendectomy

    30 days from randomization

  • +4 more secondary outcomes

Study Arms (2)

Observation

EXPERIMENTAL

Clinical follow-up for at least 6-8 hours, after follow-up repeated laboratory tests and repeated clinical examination is done. Adult Appendicitis Score is calculated after observation to determine further actions. Observation is continued in patients with decreasing score. Patients with the same or higher score undergo diagnostic imaging (score 11-15) or laparoscopy (score 16 or higher). Diagnostic imaging is abdominal ultrasound first and if the result is inconclusive or negative for appendicitis abdominal computed tomography is done. Laparoscopic appendectomy is done for those patients with appendicitis in diagnostic imaging.

Other: Observation

Diagnostic imaging

ACTIVE COMPARATOR

Patients undergo abdominal ultrasound and if the result is inconclusive or negative for appendicitis patients will have abdominal computed tomography. Laparoscopic appendectomy is done for patients with appendicitis in diagnostic imaging.

Other: Diagnostic imaging

Interventions

Diagnostic imagingOTHER

Abdominal ultrasound, followed by abdominal computed tomography when necessary

Diagnostic imaging
ObservationOTHER

Observation for 6 to 8 hours. After observation period repeated clinical examination and repeated blood test for calculation of Adult Appendicitis Score is done.

Observation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical suspicion of acute appendicitis
  • Equivocal appendicitis defined by Adult Appendicitis Score: Score ≥11 and ≤15.

You may not qualify if:

  • C-reactive protein \>99 mg/l
  • Time from symptom onset over 24 hours
  • Pregnancy
  • Antibiotics given within last 24 hours
  • Suspicion of other disease than appendicitis, that would require immediate interventions such as surgery, diagnostic imaging or gynecologic consultation
  • Missing written informed consent
  • Patient randomized earlier to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital, Meilahti Hospital

Helsinki, 00029, Finland

Location

Related Publications (2)

  • Sammalkorpi HE, Mentula P, Leppaniemi A. A new adult appendicitis score improves diagnostic accuracy of acute appendicitis--a prospective study. BMC Gastroenterol. 2014 Jun 26;14:114. doi: 10.1186/1471-230X-14-114.

    PMID: 24970111BACKGROUND

  • Lastunen KS, Leppaniemi AK, Mentula PJ. DIAgnostic iMaging or Observation in early equivocal appeNDicitis (DIAMOND): open-label, randomized clinical trial. Br J Surg. 2022 Jun 14;109(7):588-594. doi: 10.1093/bjs/znac120.

    PMID: 35482016DERIVED

Related Links

MeSH Terms

Conditions

Appendicitis

Interventions

X-RaysObservation

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, IonizingMethodsInvestigative Techniques

Study Officials

  • Panu J Mentula, M.D. Ph.D.

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 7, 2016

First Posted

April 19, 2016

Study Start

April 1, 2016

Primary Completion

April 9, 2020

Study Completion

April 30, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)