Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT04578561
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2020-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.
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': 187}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2020-10-05', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incisional hernia', 'timeFrame': '2 years', 'description': 'Detection of clinical or subclinical incisional hernia during postoperative longterm followup'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prevention of Incisional Hernia in Emergency Surgery']}, 'referencesModule': {'references': [{'pmid': '34006282', 'type': 'DERIVED', 'citation': 'Bravo-Salva A, Argudo-Aguirre N, Gonzalez-Castillo AM, Membrilla-Fernandez E, Sancho-Insenser JJ, Grande-Posa L, Pera-Roman M, Pereira-Rodriguez JA. Long-term follow-up of prophylactic mesh reinforcement after emergency laparotomy. A retrospective controlled study. BMC Surg. 2021 May 18;21(1):243. doi: 10.1186/s12893-021-01243-x.'}]}, 'descriptionModule': {'briefSummary': 'Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.', 'detailedDescription': 'Background. Prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. The present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.\n\nMethods. This study was a retrospective analysis of patients who underwent an emergency midline laparotomy between January 2009 and July 2010 with a follow-up period of longer than 2 years. Long-term outcomes and risk factors for the development of incisional hernias between patients who received a prophylactic reinforcement mesh (Group M) and suture (Group S) were compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent emergency midline laparotomies in the period between January 2009 and July 2010 in our University Hospital. We included all consecutive patients. with at least 2 years of follow-up.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing emergency midline laparotomy\n\nExclusion Criteria:\n\n* Those with need of concomitant hernia repair.\n* Those who received incisions outside the midline.\n* Those with delayed abdominal closure.\n* Those who died in the immediate postoperative period.\n* Those without a minimum 2 years of follow-up.'}, 'identificationModule': {'nctId': 'NCT04578561', 'briefTitle': 'Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital del Mar'}, 'officialTitle': 'Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.', 'orgStudyIdInfo': {'id': '20198240I'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prophylactic mesh', 'description': 'Patients who received a prophylactic mesh after emergency surgery due to high risk of incisional hernia.', 'interventionNames': ['Procedure: Prophylactic mesh use']}, {'label': 'Suture', 'description': "Patients who's laparotomies closure was using only suture without any abdominal wall reinforcement"}], 'interventions': [{'name': 'Prophylactic mesh use', 'type': 'PROCEDURE', 'otherNames': ['Incisional hernia prevention'], 'description': 'After laparotomy sutured clousur the abdominal wall wound is reinforced using a suprafascial synthetic mesh.', 'armGroupLabels': ['Prophylactic mesh']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'José A. Pereira', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Jose Antonio Pereira-Rodriguez; M.D; Ph.D.', 'investigatorFullName': 'José A. Pereira', 'investigatorAffiliation': 'Hospital del Mar'}}}}