| Background and ObjectivesBackground:Intracranial haematoma is one of the most common diseases in neurosurgery which threats to the patient’s health.In recent years,the endoscopic technology and equipment developed rapidly and using endoscopy to remove intracranial haematoma has become a new researching direction.At present,the neuroendoscopy’s main effect is lighting in the operarion which is called neuroendoscopic control technique(NECT)or neuroendoscopic assisted technique(NEAT).However,the intra-neuroendoscopic technique(INET)has seldom been reported in domestic and foreign countries for the reason of lacking matching apparatus.Objectives:INET is a new self-created technology and it was consists of two main patented products:transparent sheath(ZL 200820046232.0)and haematoma sucker(ZL 201520248717.8).Its safety,efficacy and clinical value of removing intracranial haematomas will be explored in this sutdy.Research contents and methodsA non-randomized concurrent control trial was done for three types of intracranial haematoma:brain parenchyma haematoma,severe intraventricular haematoma and subacute-chronic/chronic subdural haematoma with multi-segmentation.The number of patients enrolled in the group was calculated by the incidence of the main study indicators and grouped according to the wishes of the patients or their families.All patients were informed consent and the study was reviewed by the Southern Medical University Ethics Committee review(ethical registration number:NFEC-2015-034),and it was also register on Clinical Trials.gov website.1.Treatment of intracerebral haematoma with INETA total of 98 patients who met the inclusion criteria from May 2015 to February 2018 were included in the study series.All the patients were divided into two groups according their choices:INET group 53 cases and the control group(Hard channel technology)45 cases.All patients were diagnosed by brain CT before and the blood vessel malformation was diagnosed by computed tomographic angiography(CTA).magnetic resonance angiography(MRA)or digital subtraction angiography(DSA).Baseline indicators,intraoperative and perioperative indicators,incidence of postoperative complications,and relevant indicators at 7 days,30 days,and 6 months of follow-up were recorded and compared between the two groups.The baseline indicators with significant statistical differences and surgical methods between the two groups were included in the Logistic regression model.2.Treatment of severe intraventricular haemotoma with INETEighty-five patients who met the inclusion criteria between May 2015 and February 2018 were included in the study series and divided into two groups according to the wishes of their families:INET group 45 cases and the control group(EVD+UK)40 cases.All patients underwent brain CT to determine the diagnosis and CTA、MRA or DSA to find cerebrovascular.Baseline indicators,intraoperative and perioperative indicators,postoperative complications(intracranial infection,intracranial gas accumulation,cerebrospinal fluid leakage,secondary hemorrhage)and mortality and GOS scores at 6 months follow-up were recorded and compared between the two groups.The IVH,Graeb score,and GCS score were also compared preoperation and postoperation in 1 day,3 days and 5 days between and within groups.The baseline indicators with significant statistical differences and surgical methods between the two groups were included in the Logistic regression model.3.Treatment of subacute-chronic/chronic multiple septal subdural haematoma with INETA total of 74 patients who met the inclusion criteria during the period from May 2015 to February 2018 were enrolled in the study.The patients were divided into two groups according to the wishes of patients or their families:INET group 35 was cases and the control group was 39 cases.Baseline indicators and intraoperative and perioperative indicators were recorded and compared between the two groups,Patients’ Bender grade at 1 month and haematoma recurrence rate at 6 months postoperation were recorded and followed-up.Results1.Treatment of intracerebral haematoma with INETThe evacuation rate(84±7.1%versus 51.0±8.4%,p=0.00),7-day GCS(11.8±1.2 versus 10.4±1.5,p=0.01)and CSI(87.1±8.7 versus 80.6±10.2,p=0.02)were higher and the 30-day mortality rate(1.9%versus 15.6%,p=0.036)was lower in the INET group.However,its operation time was longer than the control group(65.2±12.5min versus 45.6±0.9min,p=0.000).Multivariable logistic regression identified that good midium-term outcome(GOS scores 4-5)was significantly associated with INET applied(OR 3.514,95%CI 1.463-8.440,p=0.005),age under 65yrs(OR 1.402,95%CI,1.041-1.888,p=0.026)and hematoma volume less than 50ml(OR 1.974,95%CI 1.302-2.993,p=0.001).2.Treatment of severe intraventricular haematoma with INETThe ICU monitoring times,VDT placement times,PDTO rate were shorter in the INET group.The variance analysis of the IVH volume,Graeb score,and GCS score at the time of preoperation and postoperation in 1 day,3 days and 5 days showed that the time effect of the two groups was statistically significant[IVH volume(F=2598.0,p=0.00);Graeb score(F=1384.8,P=0.00);GCS score(F=333.6,P=0.00)],indicating that both IVH volume and Graeb score decreased with time,GCS score increased with time.There was also significant statistical difference in the time-to-treatment interaction between the two groups[IVHvolume(F=21.1,p=0.00);Graeb score(F=94.8,P=0.00);GCS score(F=38.7,P=0.00)],which showed that the INET-treated group was more effective than the control group in clearing intraventricular haematoma.Multivariable logistic regression identified that good midium-term outcome(GOS scores 4-5)was significantly associated with INET applied(OR 1.017,95%CI 1.005-1.029,p=0.008),age under 65yrs(OR 4.223,95%CI,1.322-17.109,p=0.034)and preoperation GCS scores more than 10(OR 3.427,95%CI 1.048-11.205,p=0.040).3.Treatment of subacute-chronic/chronic multiple septal subdural haematoma with INETBaseline comparison between the two groups found that Differences in learning,There were statistically significant differences in the proportion of patients aged 65 years and younger(20%vs 43.6%,p = 0.03)and the proportion of patients with unilateral subdural hemorrhage(91.4%vs 69.2%,p = 0.02)between the two groups.The two indicators were included in logistic regression models.In the INET group,the length of the incision(4-5cm vs 3-3.5cm),the operation time(64.4±13.6min vs 44.1±10.8min,p=0.00)were all higher than those in the control group,but the placement time of the ventricle drainage tube(2.1±0.7d vs 3.9±0.8d,p=0.00)and the haematoma recurrence rate(2.9%vs 23%,p=0.04)in the 6 months follow-up were significantly smaller than those in the control group.There was no significant difference in intracranial infection rate(0%vs 5.1 p=0.52)and Bender rating overall efficiency(100%vs 89.7%,p=0.15)in follow-up 1 month,but the rate of recovery to Bender 0 in both groups was significantly higher(94.2%vs 76.9%,p=0.04)in the INET group than in the control group.Multivariable logistic regression identified that no haematoma recurrence was significantly associated with INET applied(OR 3.62,95%CI,1.202-10.911,p=0.02),age under 65yrs(OR 1.65,95%CI,1.051-2.602,p=0.03)and preoperation GCS scores more than 10(OR 1.61,95%Cl,1.067-20.418,p=0.02).Discussion and ConclusionINET is an extension of NECT to more invasive fields.In this new technique,endoscopy is not only an imaging tool that provides a good operating field of view,but also a carrier of the entire procedure,since all technical operations are performed within the endoscope working channel.The author’s team developed a national patent product transparent sheath and haematoma aspiration device to match a large channel neuroendoscopy in the INET.Transparent sheath is a good solution to the visualization of the puncture and could have a 360-degree field of vision.The application of using haematoma aspiration is a good way to solve the problem of removing tough haematoma.In general,INET is a safe and efficient new surgical option.This technique is minimally invasive and may be helpful to provide good outcomes for selected patients with intracranial haematoma removal operations.LimitationsThe present study carries some limitations.First,this study was a non randomized concurrent control trial.Second,although the surgeons have been trained to do the operation before this research,some differences in surgical techniques were still unavoidable.Third,the patients’ treatment compliance and their post-discharge rehabilitation treatment condition also have some impacts on the prognosis. |
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