Kawasaki DiseaseNCT03902262
Acute Abdomen in Kawasaki Disease
An observational study of Kawasaki Disease and Appendicitis, run by National Institute of Pediatrics, Mexico.
Trial summary
Clinical and histopathological description of three cases of Kawasaki disease with acute abdomen. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Kawasaki Disease, Appendicitis
- What is being tested?
- appendicectomy
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2016to 15 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Kawasaki disease patients
Who may be able to join
- Patients with Kawasaki disease.
- Acute abdomen requiring surgery.
Who cannot join
- Patients with chronic gastrointestinal disease.
- Incomplete data on the charts.
About this study
Official title: Acute Abdomen in Kawasaki Disease: Case Reports
Clinical and histopathological description of three cases of Kawasaki disease with acute abdomen.
Read the detailed description
CASE PRESENTATION Case 1 An 8 year-old male started 48 hrs prior to admission with abdominal pain in the right lower quadrant associated with vomiting and fever. The physical examination revealed discrete bilateral conjunctival hiperemia, right cervical adenomegaly, and severe abdominal pain in the right lower quadrant with a positive McBurney sign. Laboratory tests showed CBC: Hb 14.1 g/dl, WBC 13,800, NT 81%, LT 3%, Plt 383,000/μl. C-reactive protein 230.9 mg/dl, BNP 106.4 pg/ml (0-99). Abdominal ultrasound confirmed the diagnosis of appendicitis. A laparoscopic appendectomy was performed, and appendiceal distal enlargement with fibrinopurulent tissue was found. Twelve hours after surgery, the patient presented increased conjunctival hyperaemia, generalized rash as well as upper extremities edema and desquamation, meeting criteria for Kawasaki disease. Cardiological evaluation showed mild pericardial effusion (3mm), normal coronary arteries. Intravenous immunoglobulins (IVIG), aspirin and steroids were started with resolution of the fever, rash and the conjunctival erythema.
Case 2. A 6-year-old male started 15 days prior to admission with fever. He presented hands and feet edema and a generalized exantema. He was diagnosed with scarlet fever. The patient presented conjunctival hyperemia and cheilitis. On day 15 the patient had severe abdominal pain (right lower quadrant), and was hospitalized with the diagnosis of appendicitis. An appendicetomy was performed and two perforations of the appendix were found. Appendicitis was found (Figure 1). The patient persisted with fever and desquamation of perineal area, fingers and toes were added to the clinical picture. Laboratories reported blood count: Hb 13 g/dl, WBC 47,700/mm3 neutrophils 95% bands 8% platelets 551,000/μl, C-reactive protein 19.7 mg/dl, ESR 53 mm/hr, hypoalbuminemia 2.2 g/dl. Diagnosis of KD was established and IVIG 2 g/kg and aspirin were administered. Echocardiogram was normal. Surgical wound culture was reported positive for Enterococcus faecium and Escherchia coli. Antibiotic therapy was administered for 14 days with good evolution.
Case 3. A 5-year-old male patient, presented with a history of fever for 5 days diagnosed as bacterial tonsillitis and treated with antibiotics without resolution. On the fifth day the patient developed bilateral conjunctivitis, erythema on the lips, morbilliform exanthema in the anterior and posterior thorax and abdominal pain in mesogastrium and right lower cuadrant. His physical examination revealed non-purulent bilateral conjunctivitis, cracked lips, strawberry tongue, cervical lymphadenopathy of 0.5 x 1 cm, exanthema in thoracic and dorsal region, with significant erythema of palms and soles, without skin exfoliation. The patient presented with severe abdominal pain located in the right lower quadrant, with signs of peritoneal irritation. Abdominal ultrasound was performed and was suggestive of acute appendicitis. Laboratories reported blood count: Hb 14.1 g/dl, Hcto 40.5%, WBC 3400 /uL, neutrophils 3100/uL, lymphocytes 300 103/uL, platelets 41,000 103/uL; ferritin 1700 ng/ml, triglycerids 190 mg/dl, C-reactive protein 8 mg/dl, normal hepatic and renal function. A diagnosis of KD and acute appendicitis was made. Treatment was started with IVIG and aspirin. The boy was taken to diagnostic laparoscopy where periappendicular inflammation was found. The cecal appendix biopsy presented normal morphology up to the serous layer, with congestive vessels, interstitial edema, and mild inflammatory infiltrate with predominantly mononuclear cells within the lymphatic vessels (Figure 2). A final diagnosis of mild mononuclear periappendicitis was made. The patient had an uneventful evolution with resolution of the symptoms.
- Conditions
- Kawasaki Disease, Appendicitis
- Being tested
- appendicectomy
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appendicectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Kawasaki disease presenting with acute abdomen
Histopathological results of appendix
Measured: Up to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start14 Apr 2016
- Primary completion15 Feb 2019
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Pediatrics, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902262
- Sponsor's protocol ID
- 01-04-2019
- Status last verified
- Apr 2019
- First submitted
- 31 Mar 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Abdomen in Kawasaki Disease: Case Reports
- ClinicalTrials.gov ID
- NCT03902262
- Acronym / sponsor ID
- 01-04-2019
- Conditions
- Kawasaki Disease, Appendicitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- National Institute of Pediatrics, MexicoOther government
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical and histopathological description of three cases of Kawasaki disease with acute abdomen.
Detailed description
CASE PRESENTATION Case 1 An 8 year-old male started 48 hrs prior to admission with abdominal pain in the right lower quadrant associated with vomiting and fever. The physical examination revealed discrete bilateral conjunctival hiperemia, right cervical adenomegaly, and severe abdominal pain in the right lower quadrant with a positive McBurney sign. Laboratory tests showed CBC: Hb 14.1 g/dl, WBC 13,800, NT 81%, LT 3%, Plt 383,000/μl. C-reactive protein 230.9 mg/dl, BNP 106.4 pg/ml (0-99). Abdominal ultrasound confirmed the diagnosis of appendicitis. A laparoscopic appendectomy was performed, and appendiceal distal enlargement with fibrinopurulent tissue was found. Twelve hours after surgery, the patient presented increased conjunctival hyperaemia, generalized rash as well as upper extremities edema and desquamation, meeting criteria for Kawasaki disease. Cardiological evaluation showed mild pericardial effusion (3mm), normal coronary arteries. Intravenous immunoglobulins (IVIG), aspirin and steroids were started with resolution of the fever, rash and the conjunctival erythema.
Case 2. A 6-year-old male started 15 days prior to admission with fever. He presented hands and feet edema and a generalized exantema. He was diagnosed with scarlet fever. The patient presented conjunctival hyperemia and cheilitis. On day 15 the patient had severe abdominal pain (right lower quadrant), and was hospitalized with the diagnosis of appendicitis. An appendicetomy was performed and two perforations of the appendix were found. Appendicitis was found (Figure 1). The patient persisted with fever and desquamation of perineal area, fingers and toes were added to the clinical picture. Laboratories reported blood count: Hb 13 g/dl, WBC 47,700/mm3 neutrophils 95% bands 8% platelets 551,000/μl, C-reactive protein 19.7 mg/dl, ESR 53 mm/hr, hypoalbuminemia 2.2 g/dl. Diagnosis of KD was established and IVIG 2 g/kg and aspirin were administered. Echocardiogram was normal. Surgical wound culture was reported positive for Enterococcus faecium and Escherchia coli. Antibiotic therapy was administered for 14 days with good evolution.
Case 3. A 5-year-old male patient, presented with a history of fever for 5 days diagnosed as bacterial tonsillitis and treated with antibiotics without resolution. On the fifth day the patient developed bilateral conjunctivitis, erythema on the lips, morbilliform exanthema in the anterior and posterior thorax and abdominal pain in mesogastrium and right lower cuadrant. His physical examination revealed non-purulent bilateral conjunctivitis, cracked lips, strawberry tongue, cervical lymphadenopathy of 0.5 x 1 cm, exanthema in thoracic and dorsal region, with significant erythema of palms and soles, without skin exfoliation. The patient presented with severe abdominal pain located in the right lower quadrant, with signs of peritoneal irritation. Abdominal ultrasound was performed and was suggestive of acute appendicitis. Laboratories reported blood count: Hb 14.1 g/dl, Hcto 40.5%, WBC 3400 /uL, neutrophils 3100/uL, lymphocytes 300 103/uL, platelets 41,000 103/uL; ferritin 1700 ng/ml, triglycerids 190 mg/dl, C-reactive protein 8 mg/dl, normal hepatic and renal function. A diagnosis of KD and acute appendicitis was made. Treatment was started with IVIG and aspirin. The boy was taken to diagnostic laparoscopy where periappendicular inflammation was found. The cecal appendix biopsy presented normal morphology up to the serous layer, with congestive vessels, interstitial edema, and mild inflammatory infiltrate with predominantly mononuclear cells within the lymphatic vessels (Figure 2). A final diagnosis of mild mononuclear periappendicitis was made. The patient had an uneventful evolution with resolution of the symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Kawasaki disease patients
Key inclusion criteria (2 listed)
- Patients with Kawasaki disease.
- Acute abdomen requiring surgery.
Key exclusion criteria (2 listed)
- Patients with chronic gastrointestinal disease.
- Incomplete data on the charts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| appendicectomy | Procedure or surgery | – |
Primary outcome
Kawasaki disease presenting with acute abdomen
Time frame: Up to three weeks
Histopathological results of appendix
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Kawasaki Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Kawasaki Disease, Pilot Study
Not yet recruitingPhase 2/3
Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
Kawasaki Disease
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
RecruitingPhase 4
Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease
Kawasaki Disease, Coronary Artery Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Kawasaki Disease and Appendicitis, run by National Institute of Pediatrics, Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kawasaki disease presenting with acute abdomen (time frame: Up to three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.