- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07385261
Treatment Strategy for Complicated Pediatric Appendicitis Based on Laparoscopic Surgery (CALAP)
Treatment Strategy for Complicated Pediatric Appendicitis Based on Laparoscopic Surgery. Ten Years of Multicenter Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background and study aims: In children with complicated appendicitis significant morbidity exists with prolonged hospitalization and increased costs. The management strategy for complicated pediatric appendicitis differs depending on facility resources together with surgeon's experience. Various studies investigated the usefulness of laparoscopic than open surgery even in complicated appendicitis. However, the treatment strategy remains controversial, especially in appendicular mass as well as appendicular abscess.
Methods: This observational study included 765 children with complicated appendicitis. over 10 years period. Patients' demographics, clinical criteria for different presentations of complicated appendicitis, diagnostic work up, plans of treatment based on laparoscopic management were reviewed and analyzed regarding different variables and postoperative outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 115678
- Mohammad Daboos
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- laparoscopic management of Complicated Appendicitis with mass formation
- laparoscopic management of Complicated appendicitis with abscess formation:
- laparoscopic management of Complicated appendicitis with free intraperitoneal collection
Exclusion Criteria:
- Open surgery cases
- Patients received incomplete antibiotic therapy
- Accidental discovery coexistent pathology that necessitates open surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Complicated Appendicitis
Complicated appendicitis: refer to acute appendicitis with perforation or gangrene, appendicular mass with or without abdominal abscess formation submitted for laparoscopic management with appendectomy and intraperitoneal suction of pus over the last 10 years
|
Based on clinical findings, imaging studies and laboratory findings, after resuscitation, the decision of urgent surgery was according to the presentation Free peritoneal perforation (FPA) Perforated appendicitis with free peritoneal fluid were managed by urgent laparoscopic exploration Appendicular mass (AM) In patients presented by early mass formation lap exploration was carried out but trial of conservative management was planned for cases presented late with expected difficulty in lap dissection depending on surgical team and parental consultation, this accomplished by (nothing per mouth, I V fluid, I V antibiotic, temperature chart with U/S and biomarker follow up) Appendicular abscess (AAbs) Percutaneous drainage by availability IR team was the first choice however lap exploration and /or lap assisted extraperitoneal drainage was the second choice if IR failed or not available. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary outcomes
Time Frame: 4 years
|
postoperative outcomes any alarming symptoms of intestinal obstruction developed (vomiting, fever, or severe abdominal pain, intraperitoneal collections
|
4 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohammad Daboos, Dr, Department of pediatric surgery, faculty of medicine , Al-Azhar University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SUV-MED- SUR011-4-25-3-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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