Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT00745667
Status:
COMPLETED
Last Update Posted:
2008-09-03
First Post:
2008-09-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010439', 'term': 'Peptic Ulcer Perforation'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}], 'ancestors': [{'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-02', 'studyFirstSubmitDate': '2008-09-02', 'studyFirstSubmitQcDate': '2008-09-02', 'lastUpdatePostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'days of discharge', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'postoperative VAs pain score and opiate usage; postoperative complications; Quality of live (RAND 36, euroquol)', 'timeFrame': 'follow up 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparoscopic', 'peptic ulcer'], 'conditions': ['Perforated Peptic Ulcer']}, 'descriptionModule': {'briefSummary': 'This is a multicenter trial comparing laparoscopic correction of a perforated peptic ulcer with the open technique by upper laparotomy. Hypothesis is that after laparoscopic correction will be discharged 3 days sooner due to less postoperative pain and complications.', 'detailedDescription': 'as written above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients clinical suspected for perforated peptic ulcer\n\nExclusion Criteria:\n\n* Pregnancy\n* Younger than 18 years\n* Unable to sign consent form'}, 'identificationModule': {'nctId': 'NCT00745667', 'acronym': 'LAMA', 'briefTitle': 'The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'The LAMA Trial: Laparoscopic Correction of Perforated Peptic Ulcer Versus Open Correction by Upper Laparotomy', 'orgStudyIdInfo': {'id': 'LAMA1'}, 'secondaryIdInfos': [{'id': 'Gastrostart The Netherlands'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'laparoscopic', 'interventionNames': ['Procedure: laparoscopic surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'open correction', 'interventionNames': ['Procedure: Upper laparotomy']}], 'interventions': [{'name': 'laparoscopic surgery', 'type': 'PROCEDURE', 'description': 'laparoscopic correction perforated peptic ulcer', 'armGroupLabels': ['1']}, {'name': 'Upper laparotomy', 'type': 'PROCEDURE', 'description': 'upper laparotomy for correction of perforated peptic ulcer', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2334 CK', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Diaconessenhuis', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Johan Lange, PhD,MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Erasmus university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gastrostart', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Drs. M.J.O.E. Bertleff, MD', 'oldOrganization': 'Diaconessenhuis'}}}}