Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-20 @ 6:05 PM
Study NCT ID:
NCT06337851
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2024-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020200', 'term': 'Hematoma, Subdural, Chronic'}], 'ancestors': [{'id': 'D006408', 'term': 'Hematoma, Subdural'}, {'id': 'D020198', 'term': 'Intracranial Hemorrhage, Traumatic'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006406', 'term': 'Hematoma'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a prospective randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-23', 'studyFirstSubmitDate': '2024-01-20', 'studyFirstSubmitQcDate': '2024-03-23', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Outcome: Mortality', 'timeFrame': 'Postoperative first 12 months', 'description': 'As the Primary Outcome, we considered the success of the operation at the end of the 12-month control period (we considered patients who died or were reoperated as unsuccessful).'}, {'measure': 'The Primary Outcome: Early Postoperative Success Rate (Redo Surgery)', 'timeFrame': 'Postoperative first 12 months', 'description': 'As the Primary Outcome, we considered the success of the operation at the end of the 12-month control period (we considered patients who died or were reoperated as unsuccessful).'}], 'secondaryOutcomes': [{'measure': 'The secondary outcome: Follow-up assessment (Age)', 'timeFrame': 'One-year', 'description': 'The impact of age on the one-year prognosis of bilateral chronic subdural hematoma was assessed.'}, {'measure': 'The secondary outcome: Follow-up assessment (Sex)', 'timeFrame': 'One-year', 'description': 'The impact of sex on the one-year prognosis of bilateral chronic subdural hematoma was assessed.'}, {'measure': 'The secondary outcome: Follow-up assessment (Trauma-Relation)', 'timeFrame': 'One-year', 'description': 'The impact of trauma-relation on the one-year prognosis of bilateral chronic subdural hematoma was assessed.'}, {'measure': 'The secondary outcome: Follow-up assessment (Concomitant Pathologies)', 'timeFrame': 'One-year', 'description': 'The impact of concomitant pathologies on the one-year prognosis of bilateral chronic subdural hematoma was assessed.'}, {'measure': 'The secondary outcome: Follow-up assessment (The Glasgow Coma Scale)', 'timeFrame': 'One-year', 'description': 'The assessment aimed to determine whether the Glasgow Coma Scale scores at each follow-up period had an impact on the prognosis of bilateral chronic subdural hematoma. The Glasgow Coma Scale is reported as the combined score (which ranges from 3 to 15) and the score of each test (E for eye from 1 to 4, V for Verbal from 1 to 5, and M for Motor from1 to 6). Higher score indicates better result.'}, {'measure': 'The secondary outcome: Follow-up assessment (The Markwalder Grading Scale)', 'timeFrame': 'One-year', 'description': 'The assessment aimed to determine whether the Markwalder Grading Scale scores at each follow-up period had an impact on the prognosis of bilateral chronic subdural hematoma.\n\n0: Patient neurological normal\n\n1. Patient alert and oriented; mild symptoms such as headache; absent or mild neurological deficit such as reflex asymmetry\n2. Patient drowsy (defined as Glasgow Coma Scale (GCS) score: 13-14) or disoriented with variable neurological deficit, such as hemiparesis\n3. Patient stuporous (defined as GCS 9-12) but responding appropriately to noxious stimuli; severe focal signs such as hemiplegia\n4. Patient comatose (GCS 8 or lower) with absent motor responses to painful stimuli; decerebrate or decorticate posturing.'}, {'measure': 'The secondary outcome: Follow-up assessment (Neurological Examination - Motor)', 'timeFrame': 'One-year', 'description': 'The assessment aimed to determine whether the neurological examination (motor lateraling findings) at each follow-up period had an impact on the prognosis of bilateral chronic subdural hematoma. --Motor deficit present or absent.'}, {'measure': 'The secondary outcome: Follow-up assessment (Neurological Examination - fundus oculi)', 'timeFrame': 'One-year', 'description': 'The assessment aimed to determine whether the neurological examination (fundus oculi examination) at each follow-up period had an impact on the prognosis of bilateral chronic subdural hematoma. -- papilledema present or absent.'}, {'measure': 'The secondary outcome: Follow-up assessment (Neurological Examination - babinski sign)', 'timeFrame': 'One-year', 'description': "The assessment aimed to determine whether the neurological examination (Babinski's Sign) at each follow-up period had an impact on the prognosis of bilateral chronic subdural hematoma. Babinski sign present or absent."}, {'measure': 'The secondary outcome: Follow-up assessment (Radiological Assessments - midline shift)', 'timeFrame': 'One-year', 'description': 'It was evaluated whether radiological assessment findings (midline shift) affected the prognosis of bilateral CSDH. -- length measurement in mm'}, {'measure': 'The secondary outcome: Follow-up assessment (Radiological Assessments - hematoma volum)', 'timeFrame': 'One-year', 'description': 'It was evaluated whether radiological assessment findings (hematoma volume) affected the prognosis of bilateral CSDH. -- volume measurement in cm3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drainage', 'Chronic Subdural Hematoma', 'Consecutive', 'Simultaneous'], 'conditions': ['Subdural Hematoma, Chronic']}, 'referencesModule': {'references': [{'pmid': '10481440', 'type': 'BACKGROUND', 'citation': 'Okuchi K, Fujioka M, Maeda Y, Kagoshima T, Sakaki T. Bilateral chronic subdural hematomas resulting in unilateral oculomotor nerve paresis and brain stem symptoms after operation--case report. Neurol Med Chir (Tokyo). 1999 May;39(5):367-71. doi: 10.2176/nmc.39.367.'}, {'pmid': '16253697', 'type': 'BACKGROUND', 'citation': 'Kurokawa Y, Ishizaki E, Inaba K. Bilateral chronic subdural hematoma cases showing rapid and progressive aggravation. Surg Neurol. 2005 Nov;64(5):444-9; discussion 449. doi: 10.1016/j.surneu.2004.12.030.'}, {'pmid': '23707986', 'type': 'BACKGROUND', 'citation': 'Huang YH, Yang KY, Lee TC, Liao CC. Bilateral chronic subdural hematoma: what is the clinical significance? Int J Surg. 2013;11(7):544-8. doi: 10.1016/j.ijsu.2013.05.007. Epub 2013 May 24.'}, {'pmid': '26923835', 'type': 'BACKGROUND', 'citation': 'Agawa Y, Mineharu Y, Tani S, Adachi H, Imamura H, Sakai N. Bilateral Chronic Subdural Hematoma is Associated with Rapid Progression and Poor Clinical Outcome. Neurol Med Chir (Tokyo). 2016;56(4):198-203. doi: 10.2176/nmc.oa.2015-0256. Epub 2016 Feb 29.'}, {'pmid': '17486289', 'type': 'BACKGROUND', 'citation': 'Sucu HK, Gokmen M, Ergin A, Bezircioglu H, Gokmen A. Is there a way to avoid surgical complications of twist drill craniostomy for evacuation of a chronic subdural hematoma? Acta Neurochir (Wien). 2007 Jun;149(6):597-9. doi: 10.1007/s00701-007-1162-9. Epub 2007 May 7.'}, {'pmid': '11059659', 'type': 'BACKGROUND', 'citation': 'Nakaguchi H, Tanishima T, Yoshimasu N. Relationship between drainage catheter location and postoperative recurrence of chronic subdural hematoma after burr-hole irrigation and closed-system drainage. J Neurosurg. 2000 Nov;93(5):791-5. doi: 10.3171/jns.2000.93.5.0791.'}, {'pmid': '18666056', 'type': 'BACKGROUND', 'citation': 'Gokmen M, Sucu HK, Ergin A, Gokmen A, Bezircio Lu H. Randomized comparative study of burr-hole craniostomy versus twist drill craniostomy; surgical management of unilateral hemispheric chronic subdural hematomas. Zentralbl Neurochir. 2008 Aug;69(3):129-33. doi: 10.1055/s-2007-1004587. Epub 2008 Jul 29.'}, {'pmid': '7264730', 'type': 'BACKGROUND', 'citation': 'Markwalder TM, Steinsiepe KF, Rohner M, Reichenbach W, Markwalder H. The course of chronic subdural hematomas after burr-hole craniostomy and closed-system drainage. J Neurosurg. 1981 Sep;55(3):390-6. doi: 10.3171/jns.1981.55.3.0390.'}, {'pmid': '34647183', 'type': 'BACKGROUND', 'citation': 'Yagnik KJ, Goyal A, Van Gompel JJ. Twist drill craniostomy vs burr hole drainage of chronic subdural hematoma: a systematic review and meta-analysis. Acta Neurochir (Wien). 2021 Dec;163(12):3229-3241. doi: 10.1007/s00701-021-05019-3. Epub 2021 Oct 14.'}, {'pmid': '25224156', 'type': 'BACKGROUND', 'citation': 'Kolias AG, Chari A, Santarius T, Hutchinson PJ. Chronic subdural haematoma: modern management and emerging therapies. Nat Rev Neurol. 2014 Oct;10(10):570-8. doi: 10.1038/nrneurol.2014.163. Epub 2014 Sep 16.'}]}, 'descriptionModule': {'briefSummary': 'Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable.\n\nIn previous reports, bilateral CSDH was raised as a predictor of rapid deterioration and worse outcomes attributable to brain herniation, in comparison with unilateral ones. Nevertheless, the optimal surgical considerations in bilateral CSDH still remain controversial. Thus, this study principally aims to finding out whether consecutive removal of bilateral CSDH really poses a complication risk. The secondary objectives of the study were to obtain information about the one-year prognosis of bilateral CSDH and to find factors that affect the prognosis, if any.\n\nInclusion criteria Symptomatic adult (≥18 years-old) patients with bilateral hemispheric CSDH\n\nExclusion criteria Patients with hematoma thickness smaller than 10 mm on either side, and those who previously underwent any cranial surgery\n\nRandomization Simple randomization, without blocking, will be used to divide patients into two groups simultaneous burr hole craniostomy (Group-1) and consecutive burr hole craniostomy (Group-2).\n\nClinical Evaluation Neurological examination and scoring systems (Glasgow coma scale and Markwalder Grading) will be used.\n\nRadiological Evaluation Radiological evaluations will be made with CT and MR imaging.\n\nOperation Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point. In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated. The contralateral hematoma was evacuated.\n\nFollow-Up Depending on the subdural fluid collected, all drains will be removed within post-operative 36-48 hours.\n\nOnly the patients with epileptic history and on epileptic medication will receive postoperative antiepileptics.\n\nIn the postoperative period, a comprehensive evaluation encompassing neurological examinations and CT imaging will be performed.\n\nThis evaluation protocol will be executed immediately following the surgical procedure, after the removal of surgical drains (usually on the second postoperative day), and at designated intervals of the 1st, 3rd, 6th, and 12th months to monitor patient progress and recovery.', 'detailedDescription': "Chronic subdural hematoma (CSDH) arises at the dural border cell layer and is characterized by a pathological collection of blood, fibrin, and degradation products between the dura mater and the arachnoid mater with an insidious onset and progression. Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable.Although unilateral CSDH is seen in the majority of patients, bilateral involvement is not rare in neurosurgical practices.\n\nIn previous reports, bilateral CSDH was raised as a predictor of rapid deterioration and worse outcomes attributable to brain herniation, in comparison with unilateral ones. Nevertheless, the optimal surgical considerations in bilateral CSDH still remain controversial. Thus, this study principally aims to finding out whether consecutive removal of bilateral CSDH really poses a complication risk. The secondary objectives of the study were to obtain information about the one-year prognosis of bilateral CSDH and to find factors that affect the prognosis, if any.\n\nThe study is conducted as a prospective randomized controlled trial.\n\nInclusion criteria Symptomatic adult (≥18 years-old) patients with bilateral hemispheric CSDH\n\nExclusion criteria Patients with hematoma thickness smaller than 10 mm on either side, and those who previously underwent any cranial surgery will be excluded.\n\nRandomization Simple randomization, without blocking, will be used to divide patients into two groups simultaneous burr hole craniostomy (Group-1) and consecutive burr hole craniostomy (Group-2). Written consent will be taken from each patient and/or patient's relatives for the surgery and the use of data for this study.\n\nClinical Evaluation Neurological examination and scoring systems (Glasgow coma scale and Markwalder Grading) will be used.\n\nRadiological Evaluation Radiological evaluations will be made with CT and MR imaging.\n\nOperation The patients were operated on either under general or local anesthesia based on the recommendations of anesthesiologists and the patient's general medical status. First-generation cephalosporins were used as preoperative prophylactic antibiotics (cefazolin). Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point. In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated. The contralateral hematoma was evacuated. 12-gauge soft drainage sets with secretion bags were used for postoperative drainage in both groups.\n\nFollow-Up Depending on the subdural fluid collected, all drains will be removed within post-operative 36-48 hours.\n\nOnly the patients with epileptic history and on epileptic medication will receive postoperative antiepileptics.\n\nIn the postoperative period, a comprehensive evaluation encompassing neurological examinations and CT imaging will be performed.\n\nThis evaluation protocol will be executed immediately following the surgical procedure, after the removal of surgical drains (usually on the second postoperative day), and at designated intervals of the 1st, 3rd, 6th, and 12th months to monitor patient progress and recovery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Symptomatic bilateral hemispheric CSDH\n\nExclusion Criteria:\n\n* Hematoma thickness smaller than 10 mm on either side\n* Previously underwent any cranial surgery'}, 'identificationModule': {'nctId': 'NCT06337851', 'briefTitle': 'Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk Training and Research Hospital'}, 'officialTitle': 'Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma', 'orgStudyIdInfo': {'id': 'AtaturkTRH2003/9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Simultaneous burr hole craniostomy (Group-1)', 'description': 'Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point.', 'interventionNames': ['Other: Simultaneous burr hole craniostomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Consecutive burr hole craniostomy (Group-2)', 'description': 'In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated.', 'interventionNames': ['Other: Consecutive burr hole craniostomy']}], 'interventions': [{'name': 'Simultaneous burr hole craniostomy', 'type': 'OTHER', 'description': 'Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point.', 'armGroupLabels': ['Simultaneous burr hole craniostomy (Group-1)']}, {'name': 'Consecutive burr hole craniostomy', 'type': 'OTHER', 'description': 'In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated. The contralateral hematoma was evacuated.', 'armGroupLabels': ['Consecutive burr hole craniostomy (Group-2)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35360', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Izmir Ataturk Training and Research Hospital', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Omer Akar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Izmir Ataturk Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Since the International Clinical Trials Registration Platform (ICTRP) became operational in 2007 and we do not have such a clinical trial registry system at the national level, the registration was made retrospectively. The first surgery date of the last patient included in the study was January 2004, and the recruitment period lasted approximately 6.5 years. This policy applies to trials that began enrolling participants on or after January 1, 2019.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Neurosurgeon, Professor', 'investigatorFullName': 'Hasan Kamil Sucu', 'investigatorAffiliation': 'Ataturk Training and Research Hospital'}}}}