DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis

Appendicitis Clinical Trial

— DIAMOND  

Official title:

DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742402
• Other study ID #: HUS/95/2016
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: April 30, 2021

Study information

• Verified date: August 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

For the study equivocal appendicitis is defined as clinical suspicion of appendicitis with Adult Appendicitis Score between 11 and 15. The estimated prevalence of appendicitis in such patients is around 50%. Diagnostic imaging is done using conditional computed tomography i.e. abdominal ultrasound first and computed tomography only after negative or inconclusive appendicitis after ultrasound. In observation group repeated clinical examination is done after 6-8 hours interval with repeated blood test for calculation of Adult Appendicitis Score. Patients with decreasing score value continue observation without imaging, whereas patients with the same score value or higher (but below 16) undergo diagnostic imaging as in other group. Laparoscopy is done without imaging in patients with high score (16 or higher). Antibiotics are not allowed, but prophylactic antibiotics during induction of anesthesia are allowed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: April 30, 2021
• Est. primary completion date: April 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Appendicitis

Intervention

Other:
• Diagnostic imaging
Abdominal ultrasound, followed by abdominal computed tomography when necessary
• Observation
Observation for 6 to 8 hours. After observation period repeated clinical examination and repeated blood test for calculation of Adult Appendicitis Score is done.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital, Meilahti Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Sammalkorpi HE, Mentula P, Leppäniemi 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Appendicitis requiring surgery or other intervention		30 days from randomization
Secondary	Complicated appendicitis	Perforated appendicitis or appendiceal abscess	30 days from randomization
Secondary	Delayed appendicitis diagnosis	Diagnosis is delayed if appendicitis is diagnosed later than 24 hours from randomization	30 days from randomization
Secondary	Number of diagnostic imaging studies needed	Number of abdominal ultrasound and abdominal computed tomography per patient	30 days from randomization and within 1 year after randomization
Secondary	Appendicitis requiring surgery or other intervention		within 1 year after randomization
Secondary	Negative appendectomy	Laparoscopy done for suspected appendicitis, but patient does not have appendicitis	30 days from randomization
Secondary	Number of re-admissions to emergency unit	Any reason for re-admission are accounted	1 year
Secondary	Number of other clinically relevant findings	Findings unrelated to appendicitis	30 days from randomization
Secondary	Number of patients requiring of gynecological consultation	Applicable only in female patients	30 days from randomization
Secondary	Time for decision	The time from randomization to either decision to operate in appendicitis patients or to discharge in non-appendicitis patients.	30 days from randomization

External Links

•   Online calculator for Adult Appendicitis Score
•   Original publication of Adult Appendicitis Score