Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-05 @ 5:23 PM
Study NCT ID:
NCT00624169
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2008-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peptic Ulcer Perforation Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010439', 'term': 'Peptic Ulcer Perforation'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-26', 'studyFirstSubmitDate': '2008-02-15', 'studyFirstSubmitQcDate': '2008-02-15', 'lastUpdatePostDateStruct': {'date': '2010-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality rate', 'timeFrame': 'Within 30 days of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Perforated peptic ulcer', 'Mortality'], 'conditions': ['Peptic Ulcer Perforation']}, 'referencesModule': {'references': [{'pmid': '23215900', 'type': 'DERIVED', 'citation': 'Moller MH, Vester-Andersen M, Thomsen RW. Long-term mortality following peptic ulcer perforation in the PULP trial. A nationwide follow-up study. Scand J Gastroenterol. 2013 Feb;48(2):168-75. doi: 10.3109/00365521.2012.746393. Epub 2012 Dec 10.'}, {'pmid': '21442610', 'type': 'DERIVED', 'citation': 'Moller MH, Adamsen S, Thomsen RW, Moller AM; Peptic Ulcer Perforation (PULP) trial group. Multicentre trial of a perioperative protocol to reduce mortality in patients with peptic ulcer perforation. Br J Surg. 2011 Jun;98(6):802-10. doi: 10.1002/bjs.7429. Epub 2011 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to implement an optimized perioperative course for patients surgically treated for peptic ulcer perforation in order to improve the outcome for these patients.\n\nThe optimized perioperative course consists of a number of interventions carried out before, during and after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients surgically treated for benign peptic ulcer perforation\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Pregnant and breastfeeding women\n* Malign ulcer perforation'}, 'identificationModule': {'nctId': 'NCT00624169', 'acronym': 'PULP', 'briefTitle': 'Peptic Ulcer Perforation Study', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital at Herlev'}, 'officialTitle': 'Peptic Ulcer Perforation Study - an Optimized Perioperative Course for Patients Surgically Treated for Peptic Ulcer Perforation', 'orgStudyIdInfo': {'id': 'H-D-2007-0044'}}, 'armsInterventionsModule': {'interventions': [{'name': 'An optimized perioperative course', 'type': 'PROCEDURE', 'description': 'A number of interventions before, during and after surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Århus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2400', 'city': 'Copenhagen NV', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital Bispebjerg'}, {'zip': '3000', 'city': 'Elsinore', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital Helsingør', 'geoPoint': {'lat': 56.03606, 'lon': 12.6136}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital Herlev', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital Hillerød', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Bo Belhage, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Bispebjerg'}, {'name': 'Lars N Jørgensen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastrointestinal Surgery, Copenhagen University Hospital Bispebjerg'}, {'name': 'Iben Rosenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Hillerød'}, {'name': 'Anders U Neuenschwander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastrointestinal Surgery, Copenhagen University Hospital Hillerød'}, {'name': 'Ulf Sigild, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastrointestinal Surgery, Copenhagen University Hospital Helsingør'}, {'name': 'Anne-Margrete Hedengran, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Helsingør'}, {'name': 'Peter Holde, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology and Intensive Care, Odense University Hospital'}, {'name': 'Erik Zimmermann-Nielsen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastrointestinal Surgery, Odense University Hospital'}, {'name': 'Anita Lauritsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Århus University Hospital'}, {'name': 'Jørgen Bendix, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastrointestinal Surgery, Århus University Hospital'}, {'name': 'Sven Adamsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Gastrointestinal Surgery, Copenhagen University Hospital Herlev'}, {'name': 'Morten H Møller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev'}, {'name': 'Ann M Møller, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Copenhagen University Hospital Herlev'}, {'name': 'Jens-Ulrik S Jensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Microbiology / Copenhagen HIV Programme, Copenhagen University Hospital Hvidovre'}, {'name': 'Niels Fogh-Andersen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Biochemistry, Copenhagen University Hospital Herlev'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, 'collaborators': [{'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, {'name': 'Helsingør hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Morten Hylander Møller. MD', 'oldOrganization': 'Department of Anaesthesiology and Intensive Care Medicine'}}}}