Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-27 @ 11:37 PM
Study NCT ID:
NCT05283733
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2022-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open to Laparoscopic Reverse Conversion of Perforated Appendicitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018784', 'term': 'Abdominal Abscess'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 426}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rates of intraabdominal abscess', 'timeFrame': '3 months post operative', 'description': 'rates of complications'}, {'measure': 'rates of wound infection', 'timeFrame': '3 months post operative', 'description': 'rates of complications'}, {'measure': 'rates of ileus', 'timeFrame': 'Baseline (Hospital admission)'}, {'measure': 'rates of reoperation', 'timeFrame': '3 months post operative'}], 'secondaryOutcomes': [{'measure': 'The hospital length of stay', 'timeFrame': 'up to 3 months', 'description': 'the length of hospital stay'}, {'measure': 'the operative time', 'timeFrame': 'Intraoperative', 'description': 'Time of performing the procedures'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic', 'appendectomy', 'reverse conversion', 'reoperation', 'intraabdominal abscesses'], 'conditions': ['Laparoscopic Surgery', 'Acute Appendicitis With Rupture', 'Sepsis', 'Abdominal Abscess']}, 'descriptionModule': {'briefSummary': 'A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in management of Acute Perforated Appendicitis', 'detailedDescription': 'Introduction: Acute appendicitis (AA), a frequent intra-abdominal surgical pathology, necessitates a thorough awareness of its symptoms, examination, diagnosis, and total surgical management. The surgical approach to AA is appendectomy; nevertheless, the medical literature continues to argue the merits of open vs laparoscopic surgery. As with other laparoscopic surgical techniques, the literature reports lower discomfort, earlier resumption of oral feeding and shorter hospital stay following laparoscopic appendectomy (LA) as compared to open appendectomy (OA). Additionally, laparoscopy has some drawbacks such as greater cost and lengthier operating durations as compared to open surgery. The goal of this clinical study: was to compare open appendectomy versus laparoscopic conversion from open (reverse conversion) for the treatment of acute perforated appendicitis in our setting. Patients and procedures: 426 patients had perforated appendectomy and divided between two groups: group A (interventional) 213 patients who were subjected to the reverse conversion technique and group B (control)213 patients who were operated by the open technique. The key end goals for comparing both groups were the rates of intraabdominal abscess, rates of wound infection, rates of ileus and rates of reoperation. The hospital length of stay and the operative time were used as secondary end goals for comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* symptoms consistent with acute perforated appendicitis,\n* had ultrasound or computed tomography (CT) evidence of acute perforated appendicitis,\n* ages ranging from 16 to 65 years.\n\nExclusion Criteria:\n\n* radiological evidence of appendicular mass,\n* septic shock or multi-organ failure (MOF) at presentation,\n* Diabetes Mellitus (DM), renal failure, morbid obesity\n* recent (6-month) history of thromboembolic disease\n* immunomodulators,\n* a history of inflammatory bowel disease (IBD),\n* postoperative pathological report of the removed appendix revealed carcinoid or Crohn's disease,\n* American Society of Anesthesiology (ASA) classification more than II."}, 'identificationModule': {'nctId': 'NCT05283733', 'acronym': 'reverse', 'briefTitle': 'Open to Laparoscopic Reverse Conversion of Perforated Appendicitis', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'A Prospective Randomized Controlled Trial of Reverse Conversion (Open to Laparoscopic) in Management of Acute Perforated Appendicitis', 'orgStudyIdInfo': {'id': 'ZUH 235'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'the group who was subjected to the reverse conversion technique', 'interventionNames': ['Procedure: reverse conversion technique']}, {'type': 'NO_INTERVENTION', 'label': 'group B', 'description': 'the control group who was completed by open technique'}], 'interventions': [{'name': 'reverse conversion technique', 'type': 'PROCEDURE', 'otherNames': ['laparoscopic lavage'], 'description': 'converting open appendectomy to laparoscopic technique for proper control of intraabdominal sepsis', 'armGroupLabels': ['group A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Mohamed lotfy', 'investigatorAffiliation': 'Zagazig University'}}}}