Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-02-23 @ 11:52 PM
Study NCT ID:
NCT05591495
Status:
COMPLETED
Last Update Posted:
2022-10-24
First Post:
2022-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Laparoscopy in Upper Abdominal Surgical Emergencies in Adults: A Retrospective Observational Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000006', 'term': 'Abdomen, Acute'}], 'ancestors': [{'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 215}, 'targetDuration': '24 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-21', 'studyFirstSubmitDate': '2022-10-07', 'studyFirstSubmitQcDate': '2022-10-21', 'lastUpdatePostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative complications requiring conversion', 'timeFrame': '2 years', 'description': 'the number of patients converted to open approach'}], 'secondaryOutcomes': [{'measure': 'postoperative complications requiring reintervention', 'timeFrame': 'within 2 years of surgery', 'description': 'reintervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Emergency surgery; Laparoscopy; Upper abdominal surgery'], 'conditions': ['Acute Abdomen']}, 'descriptionModule': {'briefSummary': "Introduction Laparoscopy can be used to diagnose and treat the etiologies of acute abdominal pain. This study aimed to assess laparoscopy's effectiveness in upper gastrointestinal (G.I.T) emergencies regarding intra-and postoperative outcomes.\n\nMethod: A retrospective observational study was conducted in the emergency departments of Zagazig University on 215 patients who had upper abdominal emergency surgeries between June 2017 and June 2020.", 'detailedDescription': "When surgical procedures are standardized, laparoscopy's benefits in a range of emergency scenarios are without question acknowledged. When only a basic strategy is set for the surgery, and the surgical approach entirely depends on intra-abdominal findings, the benefits are diminished or unknown. The evidence unequivocally supports the superiority of a laparoscopic approach in numerous emergency cases, such as acute cholecystitis, gastroduodenal perforated ulcers, infected pancreatic necrosis, and splenic injuries Laparoscopy gives the primary advantages of a shorter hospital stay, a quicker procedure, and faster recovery without complications. Rapid recovery is connected with early enteral feeding. Adequate nutritional support aids in maintaining homeostasis and, as a result, enhances immunity, thereby decreasing the incidence of wound infection. Laparoscopy should be considered with caution whenever abdominal access is considered difficult, as in cases of organ enlargement, adhesion, and bowel distension. In actuality, creating the pneumoperitoneum is an essential step in the procedure. Increased intraperitoneal pressure produces cardio-respiratory and neurological effects.\n\nIn this study, the investigators designed a retrospective observational study to present our experience in assessing the outcomes of a laparoscopic approach in emergent upper abdominal surgery in terms of intraoperative and postoperative complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Between June 2017 and June 2020, 215 patients were admitted to Zagazig University Hospital's emergency surgical unit with clinical diagnoses of upper G.I.T. emergencies, namely acute cholecystitis, perforated P.U., acute necrotizing pancreatitis, and splenic trauma. The work has been reported following STROBE guidelines. To be included in the study, patients must meet the following criteria: \\>18 years of both sexes complaining of acute upper G.I.T. emergencies and undergoing laparoscopic surgeries, namely acute cholecystitis, perforated peptic ulcer, pancreatic necrosis, and splenic injuries. \\< 18 years of age and open surgeries for upper G.I.T. emergency surgeries were excluded.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnoses of upper G.I.T. emergencies, namely acute cholecystitis, perforated P.U., acute necrotizing pancreatitis, and splenic trauma.\n\nExclusion Criteria:\n\n* \\< 18 years of age and\n* open surgeries for upper G.I.T.'}, 'identificationModule': {'nctId': 'NCT05591495', 'briefTitle': 'The Role of Laparoscopy in Upper Abdominal Surgical Emergencies in Adults: A Retrospective Observational Study.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'The Role of Laparoscopy in Upper Abdominal Surgical Emergencies in Adults: A Retrospective Observational Study.', 'orgStudyIdInfo': {'id': 'zagazig university 12'}}, 'armsInterventionsModule': {'interventions': [{'name': 'laparoscopy in upper abdominal surgical emergencies in adults', 'type': 'PROCEDURE', 'description': 'evaluation the role of laparoscopy in upper GIT emergencies in adults'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professour of general and laparoscopic surgery', 'investigatorFullName': 'Tamer.A.A.M.Habeeb', 'investigatorAffiliation': 'Zagazig University'}}}}