Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-06-03 @ 10:26 AM
Study NCT ID:
NCT02742402
Status:
COMPLETED
Last Update Posted:
2021-08-25
First Post:
2016-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}, {'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 185}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-24', 'studyFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2016-04-13', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Appendicitis requiring surgery or other intervention', 'timeFrame': '30 days from randomization'}], 'secondaryOutcomes': [{'measure': 'Complicated appendicitis', 'timeFrame': '30 days from randomization', 'description': 'Perforated appendicitis or appendiceal abscess'}, {'measure': 'Delayed appendicitis diagnosis', 'timeFrame': '30 days from randomization', 'description': 'Diagnosis is delayed if appendicitis is diagnosed later than 24 hours from randomization'}, {'measure': 'Number of diagnostic imaging studies needed', 'timeFrame': '30 days from randomization and within 1 year after randomization', 'description': 'Number of abdominal ultrasound and abdominal computed tomography per patient'}, {'measure': 'Appendicitis requiring surgery or other intervention', 'timeFrame': 'within 1 year after randomization'}, {'measure': 'Negative appendectomy', 'timeFrame': '30 days from randomization', 'description': 'Laparoscopy done for suspected appendicitis, but patient does not have appendicitis'}, {'measure': 'Number of re-admissions to emergency unit', 'timeFrame': '1 year', 'description': 'Any reason for re-admission are accounted'}, {'measure': 'Number of other clinically relevant findings', 'timeFrame': '30 days from randomization', 'description': 'Findings unrelated to appendicitis'}, {'measure': 'Number of patients requiring of gynecological consultation', 'timeFrame': '30 days from randomization', 'description': 'Applicable only in female patients'}, {'measure': 'Time for decision', 'timeFrame': '30 days from randomization', 'description': 'The time from randomization to either decision to operate in appendicitis patients or to discharge in non-appendicitis patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Appendicitis']}, 'referencesModule': {'references': [{'pmid': '24970111', 'type': 'BACKGROUND', 'citation': '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': '35482016', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://bmcgastroenterol.biomedcentral.com/articles/10.1186/1471-230X-14-114', 'label': 'Original publication of Adult Appendicitis Score'}, {'url': 'http://www.appendicitisscore.com/', 'label': 'Online calculator for Adult Appendicitis Score'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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%.\n\nDiagnostic imaging is done using conditional computed tomography i.e. abdominal ultrasound first and computed tomography only after negative or inconclusive appendicitis after ultrasound.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical suspicion of acute appendicitis\n* Equivocal appendicitis defined by Adult Appendicitis Score: Score ≥11 and ≤15.\n\nExclusion Criteria:\n\n* C-reactive protein \\>99 mg/l\n* Time from symptom onset over 24 hours\n* Pregnancy\n* Antibiotics given within last 24 hours\n* Suspicion of other disease than appendicitis, that would require immediate interventions such as surgery, diagnostic imaging or gynecologic consultation\n* Missing written informed consent\n* Patient randomized earlier to the study'}, 'identificationModule': {'nctId': 'NCT02742402', 'acronym': 'DIAMOND', 'briefTitle': 'DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis', 'organization': {'class': 'OTHER', 'fullName': 'Helsinki University Central Hospital'}, 'officialTitle': 'DIAgnostic iMaging or Observation in Early Equivocal appeNDicitis - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HUS/95/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Observation', 'description': '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.', 'interventionNames': ['Other: Observation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Diagnostic imaging', 'description': '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.', 'interventionNames': ['Other: Diagnostic imaging']}], 'interventions': [{'name': 'Diagnostic imaging', 'type': 'OTHER', 'description': 'Abdominal ultrasound, followed by abdominal computed tomography when necessary', 'armGroupLabels': ['Diagnostic imaging']}, {'name': 'Observation', 'type': 'OTHER', 'description': 'Observation for 6 to 8 hours. After observation period repeated clinical examination and repeated blood test for calculation of Adult Appendicitis Score is done.', 'armGroupLabels': ['Observation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital, Meilahti Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Panu J Mentula, M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Helsinki University Central Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Panu Mentula', 'investigatorAffiliation': 'Helsinki University Central Hospital'}}}}