Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT07151651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison Between Biportal and Uniportal Endoscopic Lumbar Discectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A prospective study will be conducted at Sohag and Cairo University Hospitals on 60 patients diagnosed with lumbar disc herniation, undergoing endoscopic lumbar discectomy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-25', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary outcome measures After endoscopic lumbar discectomy Pain relief', 'timeFrame': '12 weeks up to 2 years', 'description': '1-Pain Relief: Visual Analog Scale (VAS for leg and back pain)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lumar discectomy', 'Endoscopy', 'Uniportal', 'Biportal'], 'conditions': ['Lumbar Disc Herniation']}, 'descriptionModule': {'briefSummary': 'This study aims to provide a detailed comparison between different methods of lumbar discectomy by the use of different types of spine endoscopy to evaluate the benefits and drawbacks of each type', 'detailedDescription': 'The aim of this study is to compare between uniportal and biportal endoscopic techniques in patients with lumbar disc herniation in terms of efficacy, safety, and learning curve of endoscopic spine surgery .The research will focus on clinical outcomes, functional recovery, complication rates, patient satisfaction and surgical proficiency in different endoscopic spine surgery techniques, including uniportal and biportal approaches assessing their relative advantages and limitations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients should fulfill the following criteria\n\n 1. Patients aged 18-70 years.\n 2. single-level lumbar disc herniation (L3-L4, L4-L5, or L5-S1) confirmed by MRI.\n 3. Persistent symptoms not responding to conservative management (≥6 weeks).\n\nExclusion Criteria:\n\n* All patients should not have any of the following criteria\n\n 1. Multilevel disc herniation.\n 2. Previous lumbar spine surgery, trauma or injection.\n 3. Severe spinal stenosis.\n 4. Severe osteoporosis, infection, or malignancy or autoimmune disease affecting the spine.\n 5. Uncontrolled medical comorbidities contraindicating surgery.\n 6. Instability: spondylolisthesis\\>grade 1\n 7. Marked obesity.(BMI \\>35-40 kg/m2 )'}, 'identificationModule': {'nctId': 'NCT07151651', 'briefTitle': 'A Comparison Between Biportal and Uniportal Endoscopic Lumbar Discectomy', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Endoscopic Lumbar Discectomy: A Comparative Study Between Uniportal and Biportal Endocopic Techniques on Clinical and Surgical Outcomes', 'orgStudyIdInfo': {'id': 'Sohag-Med-25-8---4MD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with lumbar disc prolapse', 'description': '1. Patients aged 18-70 years.\n2. single-level lumbar disc herniation (L3-L4, L4-L5, or L5-S1) confirmed by MRI.\n3. Persistent symptoms not responding to conservative management (≥6 weeks).', 'interventionNames': ['Procedure: Endoscopic lumbar discectomy']}], 'interventions': [{'name': 'Endoscopic lumbar discectomy', 'type': 'PROCEDURE', 'description': 'Uniportal and boportal endoscopic lumbar discectomy (transforaminal or interlaminar)', 'armGroupLabels': ['Patients with lumbar disc prolapse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Sohag', 'state': 'Sohag Governorate', 'country': 'Egypt', 'facility': 'Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'mohamed Ibrahim Amin, Assesstant lecturer', 'role': 'CONTACT', 'email': 'Mohamed-ataya@med.sohag.edu.eg', 'phone': '002 010 215 64439', 'phoneExt': '010 215 64439'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data is not collected yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer at neurosurgery department sohag University', 'investigatorFullName': 'Mohamed Ibraheem Amin', 'investigatorAffiliation': 'Sohag University'}}}}