Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-02-20 @ 12:41 PM
Study NCT ID:
NCT06363318
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Open and Laparoscopic Appendectomy in Pediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'children were randomly divided in two groups. In group A, laparoscopic appendectomy was done. In group B, open appendectomy was done'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2024-03-30', 'studyFirstSubmitQcDate': '2024-04-10', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'during surgery', 'description': 'from time of incision to skin closure'}, {'measure': 'wound infection', 'timeFrame': '10 days', 'description': 'It was labelled if there was redness, swelling or pus present at surgical wound site'}, {'measure': 'Hospital stay', 'timeFrame': '5 days', 'description': 'It was measured in terms of days required to stay in hospital after surgery. The start time will be the day of operation and end time was the day of discharge from hospital.'}, {'measure': 'Postoperative pain', 'timeFrame': '48 hours', 'description': 'It was measured by using visual analogue scale (VAS), which consists of score minimum zero to maximum ten score'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Appendicitis', 'children', 'laparoscopic appendectomy', 'open appendectomy'], 'conditions': ['Appendicitis Acute']}, 'descriptionModule': {'briefSummary': 'Introduction: In the era of minimally invasive surgery, changing trends are towards laparoscopic surgery, first introduced in 1983. Now the preferred operation for children with appendicitis, laparoscopic appendectomy is associated with a reduced risk of wound infection, less postoperative pain and shorter hospital stay as compared to open appendectomy.\n\nObjectives: To compare the outcome of open and laparoscopic appendectomy in children presenting with appendicitis in terms of operative time, postoperative pain, wound infection and hospital stay.', 'detailedDescription': 'A total of 100 children presenting with acute appendicitis were included in this study, In group A, patients were undergone laparoscopic appendectomy.\n\nIn group B, patients were undergone open appendectomy. During surgery, operative time was noted. After surgery, patients were shifted to surgical wards and were followed-up there till discharge. Patients were followed regularly by the researcher for mean post-operative pain at 24 hours. At discharge, hospital stay was noted. Then patients followed up in outpatient department for 10 days for any evidence of wound infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children of age 7-12 years of either gender diagnosed as acute appendicitis\n2. pediatric appendicitis score \\>4\n\nExclusion Criteria:\n\n1. Children with comorbidities,\n2. Perforated appendix\n3. Appendicular mass (on clinical examination). -'}, 'identificationModule': {'nctId': 'NCT06363318', 'acronym': 'Appendicitis', 'briefTitle': 'Comparison of Open and Laparoscopic Appendectomy in Pediatric Population', 'organization': {'class': 'OTHER', 'fullName': 'King Edward Medical University'}, 'officialTitle': 'Comparison of Open and Laparoscopic Appendectomy in Pediatric Population', 'orgStudyIdInfo': {'id': '0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A laparoscopic appendicectomy', 'description': 'In Group A (50 patients) laparoscopic appendicectomy was done', 'interventionNames': ['Procedure: Laparoscopic appendicectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B open appendicectomy', 'description': 'In Group B(50 patients) open appendicectomy was done', 'interventionNames': ['Procedure: Laparoscopic appendicectomy']}], 'interventions': [{'name': 'Laparoscopic appendicectomy', 'type': 'PROCEDURE', 'otherNames': ['open appendicectomy'], 'description': 'In group A laparoscopic appendicectomy was done while in group B Open appendicectomy was done', 'armGroupLabels': ['Group A laparoscopic appendicectomy', 'Group B open appendicectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53711', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Muhammad Sharif', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Muhammad Sharif, FCPS', 'role': 'STUDY_CHAIR', 'affiliation': 'King edward Medical University/Mayo Hospital Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'will be shared on demand'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Edward Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR', 'investigatorFullName': 'Muhammad Sharif', 'investigatorAffiliation': 'King Edward Medical University'}}}}