Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 5:44 PM
Study NCT ID:
NCT07385261
Status:
COMPLETED
Last Update Posted:
2026-02-04
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Strategy for Complicated Pediatric Appendicitis Based on Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment Pediatric patients aged less than 18 years, with Complicated appendicitis (with mass, appendicular abscess, and free collection) received surgical intervention with laparoscopy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 765}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcomes', 'timeFrame': '4 years', 'description': 'postoperative outcomes any alarming symptoms of intestinal obstruction developed (vomiting, fever, or severe abdominal pain, intraperitoneal collections'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic surgery', 'complicated appendicitis'], 'conditions': ['Appendix Diseases', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Observational retrospective study included 765 children with Operative management by laparoscopic appendectomy, conservative management for appendicular mass and drainage of abscess by IR should be tried first. Interval appendectomy is reserved only for patients with recurrent symptoms. the study collect the Diagnostic data ,intraoperative and post operative data to submit the strategies of laparoscopic management in limited resources setting.', 'detailedDescription': "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.\n\nMethods: 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laparoscopic management of Complicated Appendicitis with mass formation\n* laparoscopic management of Complicated appendicitis with abscess formation:\n* laparoscopic management of Complicated appendicitis with free intraperitoneal collection\n\nExclusion Criteria:\n\n* Open surgery cases\n* Patients received incomplete antibiotic therapy\n* Accidental discovery coexistent pathology that necessitates open surgery'}, 'identificationModule': {'nctId': 'NCT07385261', 'acronym': 'CALAP', 'briefTitle': 'Treatment Strategy for Complicated Pediatric Appendicitis Based on Laparoscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Treatment Strategy for Complicated Pediatric Appendicitis Based on Laparoscopic Surgery. Ten Years of Multicenter Cohort Study', 'orgStudyIdInfo': {'id': 'SUV-MED- SUR011-4-25-3-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Complicated Appendicitis', 'description': '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', 'interventionNames': ['Procedure: laparoscopic appendectomy']}], 'interventions': [{'name': 'laparoscopic appendectomy', 'type': 'PROCEDURE', 'description': '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)\n\nAppendicular 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.', 'armGroupLabels': ['Complicated Appendicitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '115678', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Mohammad Daboos', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': '\u202aMohammad Daboos\u202c, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of pediatric surgery, faculty of medicine , Al-Azhar University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohammad Daboos', 'class': 'OTHER'}, 'collaborators': [{'name': 'South Valley University', 'class': 'OTHER'}, {'name': 'Tanta University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor of pediatric surgery, Faculty of Medicine, Al-Azhar University', 'investigatorFullName': 'Mohammad Daboos', 'investigatorAffiliation': 'Al-Azhar University'}}}}