Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03902262
Other study ID # 01-04-2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 14, 2016
Est. completion date February 15, 2019

Study information

Verified date April 2019
Source National Institute of Pediatrics, Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clinical and histopathological description of three cases of Kawasaki disease with acute abdomen.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date February 15, 2019
Est. primary completion date February 15, 2019
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria:

- Patients with Kawasaki disease.

- Acute abdomen requiring surgery.

Exclusion Criteria:

- Patients with chronic gastrointestinal disease.

- Incomplete data on the charts.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
appendicectomy


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Pediatrics, Mexico

Outcome

Type Measure Description Time frame Safety issue
Primary Kawasaki disease presenting with acute abdomen Histopathological results of appendix Up to three weeks
See also
  Status Clinical Trial Phase
Completed NCT04529980 - Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis N/A
Withdrawn NCT03528343 - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy Phase 1/Phase 2
Recruiting NCT03522233 - Pediatric Appendicitis Risk Calculator (pARC) in Children With Appendix Ultrasounds
Recruiting NCT03380793 - A Trial to Assess the Efficacy and Safety of Morinidazole in Patients With Appendicitis Phase 4
Recruiting NCT02108340 - Comparative Study of Microwave Radiometry and Ultrasonography for the Diagnosis of Acute Appendicitis N/A
Terminated NCT02029781 - The Laparoscopic Appendicitis Score; a Multicenter Validation Study N/A
Completed NCT01356641 - Antibiotic Treatment Alone for Acute Simple Appendicitis in Children N/A
Terminated NCT00971438 - Structured Management of Patients With Suspicion of Appendicitis Using a Clinical Score and Selective Imaging N/A
Completed NCT00913380 - Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT Phase 3
Completed NCT01515293 - Single Incision Versus Conventional Laparoscopic Appendectomy Phase 3
Completed NCT00616616 - Single Incision Laparoscopy N/A
Completed NCT00530998 - Minimally Invasive Surgery: Using Natural Orfices
Completed NCT00195351 - Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection Phase 4
Completed NCT02916134 - Conservative Versus Operative ManageMent of Acute Uncomplicated Appendicitis N/A
Completed NCT04614649 - Right Iliac Fossa Treatment-Turkey Audit
Completed NCT04365491 - European Society for Trauma and Emergency Surgery (ESTES) Cohort Study Snapshot Audit 2020 - Acute Appendicitis
Completed NCT03770897 - Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome N/A
Completed NCT02507674 - Point of Care 3D Ultrasound for Pediatric Appendicitis: a Pilot Study
Active, not recruiting NCT01718275 - Non-operative Management of Early Appendicitis in Children
Terminated NCT01575028 - Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies Phase 2