Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-25 @ 5:27 PM
Study NCT ID:
NCT03566433
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2018-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-25', 'studyFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2018-06-12', 'lastUpdatePostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores (0-100) after surgery', 'timeFrame': 'from day 1 to 1 month postoperatively', 'description': 'Patients report pain after the operation at rest, during exercise and coughing. Higher scores means worse outcome'}], 'secondaryOutcomes': [{'measure': 'Number of operative complications', 'timeFrame': 'from day 1 to 1 month postoperatively', 'description': 'Any minor or major complication'}, {'measure': 'Number of re-operations', 'timeFrame': '1 month after the operation', 'description': 'Any re-operation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inguinal Hernia', 'Hernia']}, 'referencesModule': {'references': [{'pmid': '34791044', 'type': 'DERIVED', 'citation': 'Matikainen M, Vironen JH, Silvasti S, Ilves I, Kossi J, Kivivuori A, Paajanen H. A randomized clinical trial comparing early patient-reported pain after open anterior mesh repair versus totally extraperitoneal repair of inguinal hernia. Br J Surg. 2021 Dec 1;108(12):1433-1437. doi: 10.1093/bjs/znab354.'}]}, 'descriptionModule': {'briefSummary': 'Immediate pain reaction and return to work after TEP or Lichtenstein hernia repair have not been studied. In this multicenter trial the patients are allocated to surgery using TEP (n=50) or Lichtenstein (n=50) technique. Pain and return to work are recorded postoperatively up to one month. Immediate and late complications are also analyzed.', 'detailedDescription': 'Patient characteristics are recorded before surgery. The adult patients with inguinal hernia are randomized into endoscopic totally extraperitoneal hernioplasty (TEP) or open Lichtenstein hernioplasty. Pain reaction to surgery and return to work are asked many times using questionnaire and pain diary (pain scores from 1h to 30 days after surgery). Surgical complications and use of pain killers are carefully recorded. Clinical examination is performed if necessary.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nClinical diagnosis of symptomatic inguinal hernia Age 18-80\n\nExclusion Criteria:\n\nLarge scrotal hernia Bilateral hernia Symptom-free hernia Inguinal pain without clinical evidence of hernia Asa class≥3'}, 'identificationModule': {'nctId': 'NCT03566433', 'briefTitle': 'Postoperative Pain After Endoscopic TEP vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Early Postoperative Pain After Totally Extraperitoneal Endoscopic Technique (TEP) vs. Lichtenstein Hernioplasty in Inguinal Hernia Repair: a Prospective Randomized Multi-center Study', 'orgStudyIdInfo': {'id': 'KuopioUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endoscopic TEP surgery', 'description': 'Routine total extraperitoneal technique surgery for inguinal hernia', 'interventionNames': ['Procedure: Tep surgery for inguinal hernia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open Lichtenstein hernioplasty', 'description': 'Routine lichtenstein surgery for inguinal hernia', 'interventionNames': ['Procedure: Lichtenstein']}], 'interventions': [{'name': 'Tep surgery for inguinal hernia', 'type': 'PROCEDURE', 'description': 'TEP surgery', 'armGroupLabels': ['Endoscopic TEP surgery']}, {'name': 'Lichtenstein', 'type': 'PROCEDURE', 'description': 'Lichtenstein surgery for inguinal hernia', 'armGroupLabels': ['Open Lichtenstein hernioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70600', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'overallOfficials': [{'name': 'Hannu Paajanen, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kuopio University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helsinki University Central Hospital', 'class': 'OTHER'}, {'name': 'North Karelia Central Hospital', 'class': 'OTHER'}, {'name': 'Mikkeli Central Hospital', 'class': 'OTHER'}, {'name': 'Päijänne Tavastia Central Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}