Nctid:
NCT06615518
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007405", "term"=>"Intervertebral Disc Displacement"}, {"id"=>"D011843", "term"=>"Radiculopathy"}, {"id"=>"D006547", "term"=>"Hernia"}], "ancestors"=>[{"id"=>"D010523", "term"=>"Peripheral Nervous System Diseases"}, {"id"=>"D009468", "term"=>"Neuromuscular Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D020763", "term"=>"Pathological Conditions, Anatomical"}, {"id"=>"D013122", "term"=>"Spinal Diseases"}, {"id"=>"D001847", "term"=>"Bone Diseases"}, {"id"=>"D009140", "term"=>"Musculoskeletal Diseases"}], "browseLeaves"=>[{"id"=>"M9625", "name"=>"Hernia", "asFound"=>"Herniation", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M14689", "name"=>"Radiculopathy", "asFound"=>"Radiculopathy", "relevance"=>"HIGH"}, {"id"=>"M10439", "name"=>"Intervertebral Disc Displacement", "asFound"=>"Disc Herniation", "relevance"=>"HIGH"}, {"id"=>"M13432", "name"=>"Peripheral Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12411", "name"=>"Neuromuscular Diseases", "relevance"=>"LOW"}, {"id"=>"M22519", "name"=>"Pathological Conditions, Anatomical", "relevance"=>"LOW"}, {"id"=>"M15919", "name"=>"Spinal Diseases", "relevance"=>"LOW"}, {"id"=>"M5126", "name"=>"Bone Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>220}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-12", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-26", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change in Back and Leg Pain Intensity (measured by the Visual Analog Scale [VAS])", "timeFrame"=>"Baseline, 1 month, 3 months, 6 months, 12 months post-surgery", "description"=>"Description: The primary outcome measure will assess changes in back and leg pain intensity reported by patients using the Visual Analog Scale (VAS) at each follow-up. The reduction in pain scores will be compared between the FELD and MD groups to evaluate which technique provides superior pain relief over time."}], "secondaryOutcomes"=>[{"measure"=>"Change in Functional Disability (measured by the Oswestry Disability Index [ODI])", "timeFrame"=>"Baseline, 1 month, 3 months, 6 months, 12 months post-surgery", "description"=>"This measure will assess the improvement in functional disability using the ODI, comparing the degree of disability reduction between the FELD and MD groups at each follow-up point."}, {"measure"=>"Change in Overall Patient Well-Being (measured by the Core Outcome Measures Index [COMI])", "timeFrame"=>"Baseline, 1 month, 3 months, 6 months, 12 months post-surgery", "description"=>"The COMI questionnaire will be used to evaluate changes in the patient's overall perception of their condition, including pain, function, and quality of life. Comparisons will be made between FELD and MD groups to assess which method leads to a greater improvement in patient well-being."}, {"measure"=>"Recurrence Rate of Disc Herniation (measured by MRI and clinical assessment)", "timeFrame"=>"1 month, 3 months, 6 months, 12 months post-surgery", "description"=>"The rate of recurrent disc herniation will be monitored through MRI scans and clinical evaluations. The rate of recurrence in both the FELD and MD groups will be compared to determine if one technique results in a higher recurrence rate."}, {"measure"=>"Time to Return to Work", "timeFrame"=>"Up to 12 months post-surgery", "description"=>"This measure will assess the number of days taken for patients to return to their regular work activities post-surgery, comparing the recovery times between the FELD and MD groups."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Lumbar Degenerative Disease", "Lumbar Radiculopathy", "Sciatic Leg Pain", "Sciatic Nerve Compression", "Discopathy", "Disc Herniation", "Disc Herniation with Radiculopathy"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to compare the clinical effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in patients aged 18-85 with single-level lumbar disc herniation who have not undergone prior lumbar surgery. This study also aims to perform a radiological analysis of MRI scans before and after treatment to optimize patient selection and surgical strategies. The main questions it aims to answer are:\n\n* Does FELD provide superior early postoperative pain relief (measured by VAS) compared to MD?\n* Does FELD offer better functional recovery (measured by COMI and ODI scores) postoperatively compared to MD?\n* Can radiological analysis of pre- and post-operative MRI images help optimize patient qualification and guide surgical strategies?\n\nResearchers will compare patients undergoing FELD to those undergoing MD to see if endoscopic techniques result in faster recovery and lower early postoperative pain while maintaining similar long-term outcomes. The study will also analyze how MRI findings correlate with clinical outcomes to refine operative decision-making.\n\nParticipants will:\n\n* Undergo either FELD or MD surgery\n* Complete VAS, COMI, and ODI questionnaires at pre-specified follow-up intervals (1, 3, 6, and 12 months post-surgery)\n* Have MRI scans 24 hours before surgery, 24 hours after surgery, and at each follow-up to assess disc recurrence, residual pathology, and to optimize surgical strategies."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients aged 18-85 years with symptoms of sciatica lasting more than 6 weeks\n* Shorter duration in cases where symptoms significantly impair normal functioning or in cases of muscle strength deficits\n* Symptoms correlate with MRI findings of lumbar spine pathology, showing the presence of intervertebral disc herniation (protrusion, extrusion, or sequestration) causing nerve root compression in the lumbar spine.\n\nExclusion Criteria:\n\n* Previous lumbar spine surgery in the lumbar-sacral region\n* MRI findings showing degenerative or stenotic spinal canal changes\n* Multi-level pathology where identification of the pain source is not possible\n* Pregnancy"}, "identificationModule"=>{"nctId"=>"NCT06615518", "briefTitle"=>"Comparison of Clinical Effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD) in Patients with Lumbar Disc Herniation", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Opole"}, "officialTitle"=>"\"Radiological Analysis of MRI Images in Patients Treated with Minimally Invasive Microsurgical and Endoscopic Techniques: a Randomized Study Comparing the Clinical Effectiveness of Full Endoscopic Lumbar Discectomy (FELD) and Microdiscectomy (MD)\"", "orgStudyIdInfo"=>{"id"=>"UO/0001/KB/2024"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"TELD", "description"=>"Transforaminal endoscopic lumbar discectomy", "interventionNames"=>["Procedure: transforaminal endoscopic lumbar discectomy"]}, {"type"=>"EXPERIMENTAL", "label"=>"IELD", "description"=>"Interlaminar endoscopic lumbar discectomy", "interventionNames"=>["Procedure: Interlaminar endoscopic lumbar discectomy"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"MD", "description"=>"microdiscectomy", "interventionNames"=>["Procedure: Microdiscectomy"]}], "interventions"=>[{"name"=>"transforaminal endoscopic lumbar discectomy", "type"=>"PROCEDURE", "description"=>"FELD is a minimally invasive spine surgery technique performed through small incisions using an endoscope. The procedure involves accessing the herniated disc through either the transforaminal (TELD) or interlaminar (IELD) approach, depending on the location of the disc herniation. The endoscopic approach allows for direct visualization of the affected area using a camera, and specialized instruments are used to remove the herniated portion of the disc.\n\nWhat distinguishes this intervention:\n\n* Small incisions (typically \\<1 cm) result in less soft tissue damage compared to traditional open surgery.\n* Real-time endoscopic visualization allows for precise disc removal and reduced trauma to surrounding structures such as muscles and ligaments.\n* Minimized postoperative pain and faster recovery times due to the less invasive nature of the procedure.\n* Outpatient or short hospital stay is often possible, contributing to faster patient discharge.", "armGroupLabels"=>["TELD"]}, {"name"=>"Interlaminar endoscopic lumbar discectomy", "type"=>"PROCEDURE", "description"=>"FELD is a minimally invasive spine surgery technique performed through small incisions using an endoscope. The procedure involves accessing the herniated disc through either the transforaminal (TELD) or interlaminar (IELD) approach, depending on the location of the disc herniation. The endoscopic approach allows for direct visualization of the affected area using a camera, and specialized instruments are used to remove the herniated portion of the disc.\n\nWhat distinguishes this intervention:\n\n* Small incisions (typically \\<1 cm) result in less soft tissue damage compared to traditional open surgery.\n* Real-time endoscopic visualization allows for precise disc removal and reduced trauma to surrounding structures such as muscles and ligaments.\n* Minimized postoperative pain and faster recovery times due to the less invasive nature of the procedure.\n* Outpatient or short hospital stay is often possible, contributing to faster patient discharge.", "armGroupLabels"=>["IELD"]}, {"name"=>"Microdiscectomy", "type"=>"PROCEDURE", "description"=>"Microdiscectomy is a conventional surgical technique for treating lumbar disc herniation, involving a small open incision. In this procedure, the surgeon makes an incision typically between 2-3 cm in length, then uses an operating microscope to gain magnified visualization of the herniated disc. The surgeon removes part of the lamina (laminotomy) to access the disc and nerves. Special instruments are used to remove the herniated portion of the disc that is compressing the spinal nerves, relieving symptoms such as pain, numbness, and weakness.\n\nWhat distinguishes this intervention:\n\n* Larger incision (2-3 cm) compared to FELD, but still smaller than traditional open discectomy, allowing better visualization.\n* Microscopic magnification allows precise removal of disc material while minimizing trauma to surrounding neural structures.\n* Direct access to the affected area via the removal of part of the lamina (laminotomy), offering a well-established and highly effective approach to reli", "armGroupLabels"=>["MD"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"45-001", "city"=>"Opole", "state"=>"Opolskie", "status"=>"RECRUITING", "country"=>"Poland", "contacts"=>[{"name"=>"Dariusz Latka, Prof.", "role"=>"CONTACT", "email"=>"dariusz.latka@uni.opole.pl", "phone"=>"+48601853513"}, {"name"=>"Katarzyna Sznajder, PhD", "role"=>"CONTACT"}, {"name"=>"Marek Waligora, PhD", "role"=>"CONTACT"}], "facility"=>"Uniwesytecki Szpital Kliniczny", "geoPoint"=>{"lat"=>50.67211, "lon"=>17.92533}}, {"zip"=>"45-221", "city"=>"Opole", "state"=>"Opolskie", "status"=>"RECRUITING", "country"=>"Poland", "contacts"=>[{"name"=>"Kajetan Latka, PhD", "role"=>"CONTACT", "email"=>"kajetan.latka@uni.opole.pl", "phone"=>"+48609225084"}, {"name"=>"Kacper Domisiewicz, MD", "role"=>"CONTACT"}, {"name"=>"Piotr Lasowy, MD", "role"=>"CONTACT"}, {"name"=>"Dariusz Latka, Prof.", "role"=>"CONTACT"}, {"name"=>"Krzysztof Kandziora, MD", "role"=>"CONTACT"}], "facility"=>"Wojewódzki Szpital Specjalistyczny im Św Jadwigi w Opolu", "geoPoint"=>{"lat"=>50.67211, "lon"=>17.92533}}], "centralContacts"=>[{"name"=>"Kajetan Latka, PhD", "role"=>"CONTACT", "email"=>"kajetan.latka@uni.opole.pl", "phone"=>"+48609225084"}], "overallOfficials"=>[{"name"=>"Kajetan Latka, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Opole"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"YES", "description"=>"The following specific Individual Participant Data (IPD) will be shared:\n\n* De-identified individual clinical data: This includes data from questionnaires such as Visual Analog Scale (VAS), Core Outcome Measures Index (COMI), and Oswestry Disability Index (ODI), collected at baseline and during follow-up visits (1, 3, 6, and 12 months post-surgery).\n* De-identified radiological data: MRI images taken 24 hours before surgery, 24 hours after surgery, and at each follow-up visit will be shared for the purpose of comparing radiological outcomes.\n* De-identified recurrence and complication data: This includes any clinical or radiological evidence of recurrent disc herniation or complications (e.g., infection, reoperation).\n\nThe data will be made available upon reasonable request for research purposes to qualified researchers following the publication of the primary study results."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Opole", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"PhD, Deputy-Head Neurosurgery Department WSS Opole", "investigatorFullName"=>"Kajetan Latka", "investigatorAffiliation"=>"University of Opole"}}}}
