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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic imaging | Other | Abdominal ultrasound, followed by abdominal computed tomography when necessary |
|
| Measure | Description | Time Frame |
|---|---|---|
| Appendicitis requiring surgery or other intervention | 30 days from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Complicated appendicitis | Perforated appendicitis or appendiceal abscess | 30 days from randomization |
| Delayed appendicitis diagnosis | Diagnosis is delayed if appendicitis is diagnosed later than 24 hours from randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panu J Mentula, M.D. Ph.D. | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital, Meilahti Hospital | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24970111 | Background | 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. | |
| 35482016 | Derived | 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. |
| Label | URL |
|---|---|
| Original publication of Adult Appendicitis Score | View source |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| D019370 | Observation |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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| Observation | Other | Observation for 6 to 8 hours. After observation period repeated clinical examination and repeated blood test for calculation of Adult Appendicitis Score is done. |
|
| 30 days from randomization |
| 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 |
| Appendicitis requiring surgery or other intervention | within 1 year after randomization |
| Negative appendectomy | Laparoscopy done for suspected appendicitis, but patient does not have appendicitis | 30 days from randomization |
| Number of re-admissions to emergency unit | Any reason for re-admission are accounted | 1 year |
| Number of other clinically relevant findings | Findings unrelated to appendicitis | 30 days from randomization |
| Number of patients requiring of gynecological consultation | Applicable only in female patients | 30 days from randomization |
| 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 |
| Online calculator for Adult Appendicitis Score | View source |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D008722 | Methods |
| D008919 | Investigative Techniques |