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Acute uncomplicated appendicitis in children - Is surgery the preferred option?

Conservative treatment with antibiotics versus emergency appendectomy for management of acute nonperforated appendicitis in children: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011088
Enrollment
106
Registered
2018-01-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute Non-Perforated Appendicitis in Children

Interventions

Intervention1: A.Conservative Management Group (CMx): Broad spectrum intravenous antibiotics (Ceftriaxone 50 mg/kg/dose 12 hourly, Amikacin 7.5 mg/kg/dose 12 hourly and Metronidazole 10 mg/kg/dose 8 h

Sponsors

All India Institute of Medical Sciences Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age between 3 to 14 years both male and female. 2.Symptoms of Pain Abdomen, Anorexia, Nausea, Vomiting, Fever. 3.Signs of Focal Peritonitis (Guarding, Rebound tenderness) in Right Iliac Fossa (RIF). 4.Laboratory Findings of â?? Total Leukocyte Count, â?? Neutrophil count, â?? CRP, â?? LRG. 5.Abdominal Ultrasonogram s/o noncompressible nonperistaltic tubular structure >= 6 mm in AP diameter in RIF, probe tenderness in RIF, hyperechoic pericaecal fat & free fluid. 6.Abdominal CT scan suggestive of acute nonperforated appendicitis

Exclusion criteria

Exclusion criteria: 1.History of Recurrent Appendicitis 2.History of Chronic , Intermittent abdominal pain 3.Diffuse abdominal tenderness on clinical evaluation 4.Generalized Septicemia , Other Systemic illnesses 5.Abdominal Ultrasonography s/o Appendicolith, Appendicular Perforation ,Periappendicular Abscess or Phlegmon , Pan-peritonitis

Design outcomes

Secondary

MeasureTime frame
a)Length of Stay in the Hospital b)Cost of Treatment c)Perforation Rate in CMx group d)Lump formation in CMx group e)Appendicular Abscess in CMx group f)Intraoperative Complications in SMx group g)Wound Complications in SMx group h)Negative Appendectomy Rate in SMx group i)Disability Days for the Child and Parents j)Missed School Days k)Measures of Quality of Life (PedsQLTM survey) l)Health Care Satisfaction (1 to 10 score) m)Recurrence Rate of Appendicitis in CMx groupTimepoint: All the children enrolled in the CMx group will be called / telephoned for follow up at 1 month, 3 months and 1 year interval.

Primary

MeasureTime frame
The feasibility and safety of the Conservative Management (CMx) with Antibiotics in children with acute Nonperforated Appendicitis.Timepoint: 1st Month - Feasibility assessment 6th Month - Mid-recruitment review 1 year - Final assessment.

Countries

India

Contacts

Public ContactDr Bikasha Bihary Tripathy

All India Institute of Medical Sciences, Bhubaneswar

bbtripathy.dr@gmail.com9438884102

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026