Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-02 @ 8:25 AM
Study NCT ID:
NCT04683367
Status:
COMPLETED
Last Update Posted:
2020-12-24
First Post:
2020-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up of Symptomless Inguinal and Ventral Hernias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D006555', 'term': 'Hernia, Ventral'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D059685', 'term': 'Herniorrhaphy'}], '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'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-21', 'studyFirstSubmitDate': '2020-12-16', 'studyFirstSubmitQcDate': '2020-12-21', 'lastUpdatePostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of operated hernia', 'timeFrame': '15 years', 'description': 'occult hernia operated because of symptoms'}], 'secondaryOutcomes': [{'measure': 'number of symptomatic hernia', 'timeFrame': '15 years', 'description': 'incipient, asymptomatic hernia becomes symptomatic during follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inguinal hernia', 'ventral hernia', 'laparoscopic diagnosis'], 'conditions': ['Hernia, Inguinal', 'Hernia, Ventral', 'Laparoscopy']}, 'descriptionModule': {'briefSummary': 'The orifices of all inguinal and ventral (including Spigelian) hernias were carefully recorded at the beginning of laparoscopy (n=201) of other reason (cholecystectomy, fundoplication) in 2003-5. The patients with occult hernias (n=43) were followed-up 15 years to find out what percentage of hernias would become symptomatic.', 'detailedDescription': 'This was a prospective laparoscopic study of 201 consecutive adult patients operated in 2003-5. There were 133 females and 68 males with a mean age 53 ± 14 years. The index laparoscopic operation included 104 cholecystectomies, 55 fundoplications, 36 diagnostic, 5 appendectomies and one insertion of peritoneal catheter. A careful clinical examination of the groin and ventral region was performed on everybody and all patients with clinical hernias were excluded. Laparoscopic exploration of the inguinal region was considered safe and did not greatly increase the operative time. All patients were informed that hernial orifices would be explored during laparoscopy, and a written consent was asked prior to surgery. Permission to repair large hernias (\\> 1 cm) was also obtained before laparoscopy.\n\nThe patients were followed-up 15 years to find out, what percentage of occult, symptomless inguinal and ventral hernias were later operated because of harmfull symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* occult inguinal or ventral hernia diagnosed in laparoscopic surgery\n\nExclusion Criteria:\n\n* clinically diagnosed inguinal or ventral hernia'}, 'identificationModule': {'nctId': 'NCT04683367', 'acronym': 'hernia', 'briefTitle': 'Follow-up of Symptomless Inguinal and Ventral Hernias', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': '15-year Follow-up of Laparoscopically Diagnosed Occult Inguinal and Ventral Hernias', 'orgStudyIdInfo': {'id': '139/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'clinical hernia', 'description': 'developing clinical hernia', 'interventionNames': ['Procedure: laparoscopic surgery']}], 'interventions': [{'name': 'laparoscopic surgery', 'type': 'PROCEDURE', 'otherNames': ['hernioplasty'], 'description': 'laparoscopic repair of hernia', 'armGroupLabels': ['clinical hernia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70600', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Hannu EK Paajanen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'department of Surgery, Kuopio Univ Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Hannu Paajanen', 'investigatorAffiliation': 'Kuopio University Hospital'}}}}