Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT03495557
Status:
COMPLETED
Last Update Posted:
2022-03-23
First Post:
2018-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Control will have simple closure while experimental group will have simple closure+mesh'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2018-03-23', 'studyFirstSubmitQcDate': '2018-04-04', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Umbilical trocar site hernia incidence', 'timeFrame': '3 years', 'description': 'Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation)'}], 'secondaryOutcomes': [{'measure': 'Seroma incidence', 'timeFrame': '6 months', 'description': 'A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment)'}, {'measure': 'Hematoma incidence', 'timeFrame': '6 months', 'description': 'A localized collection of extravasated blood clotted under the tissue (clinical assessment)'}, {'measure': 'Wound infection incidence', 'timeFrame': '6 months', 'description': 'Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically'}, {'measure': 'Pain presence', 'timeFrame': '6 months, 1 and 3 years', 'description': 'Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain)'}, {'measure': 'Hospital discharge', 'timeFrame': '48 hours', 'description': 'When patients leave the hospital after the intervention, measured by hours'}, {'measure': 'Operative time', 'timeFrame': '2 hours', 'description': 'Intervention duration, measured by minutes'}, {'measure': 'Return to regular activity', 'timeFrame': '6 months', 'description': 'When patient return to job or regular activities after surgery, measured by days'}, {'measure': 'Patient satisfaction', 'timeFrame': '3 years', 'description': 'How satisfied/unsatisfied is the patient with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)'}, {'measure': 'Surgeon satisfaction', 'timeFrame': '3 years', 'description': 'How satisfied/unsatisfied is the surgeon with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hernia', 'Cholecystectomy', 'Mesh fixation'], 'conditions': ['Incisional Hernia']}, 'referencesModule': {'references': [{'pmid': '39207550', 'type': 'DERIVED', 'citation': 'Ciscar A, Sanchez-Saez E, Vila Tura M, Ruiz de Leon P, Gomez Pallares M, Troyano Escribano D, Abadal Prades M, Mans Muntwyler E, Pereira JA, Badia JM. Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial. Hernia. 2024 Dec;28(6):2187-2194. doi: 10.1007/s10029-024-03124-7. Epub 2024 Aug 29.'}]}, 'descriptionModule': {'briefSummary': 'A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors.', 'detailedDescription': 'Randomized controlled trial. Patients with more than two incisional hernia risk factors (age ≥70, BMI ≥30, diabetes mellitus, fascial enlargement) who undergo elective/emergent cholecystectomy. Control arm: fascial closure with simple PDS 2/0 Stitches. Study arm: fascial closure with simple PDS 2/0 stitches and onlay polypropylene mesh placement. Main outcome umbilical trocar site hernia incidence during a 3 years follow up. Clinical and radiological assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Laparoscopic cholecystectomy\n* Emergent/elective\n* ≥2 risk factors: diabetes mellitus, age ≥70 years, BMI ≥30, fascial enlargement\n\nExclusion Criteria:\n\n* Conversion to laparotomy\n* Emergent re intervention\n* Immunosuppression\n* Umbilical hernia'}, 'identificationModule': {'nctId': 'NCT03495557', 'acronym': 'PSHERNIA', 'briefTitle': 'Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Mataró'}, 'officialTitle': 'Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'PORT SITE HERNIA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Simple closure', 'interventionNames': ['Procedure: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Simple closure + mesh', 'interventionNames': ['Device: Experimental']}], 'interventions': [{'name': 'Control', 'type': 'PROCEDURE', 'description': 'Fascial closure with simple polydioxanone suture 2/0 stitches', 'armGroupLabels': ['Control']}, {'name': 'Experimental', 'type': 'DEVICE', 'description': 'Onlay polypropylene mesh placement (MN mesh)', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08304', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Mataró', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}], 'overallOfficials': [{'name': 'Ana Ciscar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Mataró'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Mataró', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ana Ciscar', 'investigatorAffiliation': 'Hospital de Mataró'}}}}