Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2026-01-01 @ 9:25 PM
Study NCT ID:
NCT06870604
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Laparoscopic Surgery and Open Surgery for Repair of Gastric Perforation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 827}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2025-03-06', 'studyFirstSubmitQcDate': '2025-03-06', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'From date of diagnosis until the date of death from any cause or or loss to follow-up, whichever came first, assessed up to 60 months.', 'description': 'Overall survival (OS) was described as time from date of diagnosis until the date of death from any cause or or loss to follow-up.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric perforation', 'laparoscopic surgery', 'open surgery', 'PSM', 'overall complications'], 'conditions': ['Gastric Perforation']}, 'descriptionModule': {'briefSummary': "Gastric perforation (GP) is a penetrating lesion of the gastric wall that accounts for 10-15% of all peptic ulcer perforations, and most GP are spontaneous perforations caused by ulcer disease. Due to the presence of gastric acid, most patients often present to the emergency department with severe abdominal or chest pain due to chemical peritonitis within a few hours of perforation. Emergency physicians often quickly diagnose GP by using a chest x-ray or CT in an upright position and the patient's symptoms. Studies have shown that about 80-85% of patients with GP had subphrenic free gas visible on x-ray in the upright position.\n\nSurgery is currently the mainstay of treatment for most GP, and almost all cases require urgent surgical repair.2 Over the past few years, laparoscopic surgery has become increasingly popular in clinical practice due to its advantages of less pain, less scarring, and early mobility out of bed, and has become the standard treatment for many elective and emergency procedures.\n\nSince the laparoscopic study of PPU was first published by Mouret P in 1990, investigators have launched extensive discussions on the effects of laparoscopic surgery and open surgery in patients with perforated ulcers. However, to our knowledge, there are few separate discussions on GP, and the postoperative prognosis of laparoscopic surgery for patients with GP is less clear. Therefore, the aim of this multicenter, large-scale retrospective study was to compare the clinical outcomes of laparoscopic surgery and open surgery in patients with GP, to investigate whether laparoscopic surgery is safe and feasible for patients with GP, and to provide reliable evidence for surgical strategies in patients with GP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients diagnosed with gastric perforation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years;\n* patients diagnosed with gastric perforation.\n\nExclusion Criteria:\n\n* patients with incomplete clinical data;\n* laparoscopic surgery transfer to open surgery.'}, 'identificationModule': {'nctId': 'NCT06870604', 'briefTitle': 'Comparison of Laparoscopic Surgery and Open Surgery for Repair of Gastric Perforation', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Comparison of Laparoscopic Surgery and Open Surgery for Repair of Gastric Perforation: a Multicenter, Propensity Score-matched Analysis', 'orgStudyIdInfo': {'id': 'ZZ2025-131-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the gastric perforation group', 'description': 'patients diagnosed as gastric perforation', 'interventionNames': ['Procedure: do open surgery', 'Procedure: do laparoscopic surgery']}], 'interventions': [{'name': 'do open surgery', 'type': 'PROCEDURE', 'description': 'Open surgery was performed in patients undergoing gastric perforation', 'armGroupLabels': ['the gastric perforation group']}, {'name': 'do laparoscopic surgery', 'type': 'PROCEDURE', 'description': 'Laparoscopic surgery was performed in patients undergoing gastric perforation', 'armGroupLabels': ['the gastric perforation group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical centres conducting this study are not allowed to disclose patient information and data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong Peng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dong Peng', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}