Comparison of endoscopic evacuation, stereotactic aspiration and craniotomy for the treatment of supratentorial hypertensive intracerebral haemorrhage: study protocol for a randomised controlled trial

Abstract

BackgroundHypertensive intracerebral haemorrhage (HICH) is the most common form of haemorrhagic stroke with the highest morbidity and mortality of all stroke types. The choice of surgical or conservative treatment for patients with HICH remains controversial. In recent years, minimally invasive surgeries, such as endoscopic evacuation and stereotactic aspiration, have been attempted for haematoma removal and offer promise. However, research evidence on the benefits of endoscopic evacuation or stereotactic aspiration is still insufficient.Methods/designA multicentre, randomised controlled trial will be conducted to compare the efficacy of endoscopic evacuation, stereotactic aspiration and craniotomy in the treatment of supratentorial HICH. About 1350 eligible patients from 10 neurosurgical centres will be randomly assigned to an endoscopic group, a stereotactic group and a craniotomy group at a 1:1:1 ratio. Randomisation is undertaken using a 24-h randomisation service accessed by telephone or the Internet. All patients will receive the corresponding surgery based on their grouping. They will be followed-up at 1, 3 and 6 months after surgery. The primary outcome is the modified Rankin Scale at 6-month follow-up. Secondary outcomes include: haematoma clearance rate; Glasgow Coma Scale 7 days after surgery; rebleeding rate; intracranial infection rate; hospitalisation time; mortality at 1 month and 3 months after surgery; the Barthel Index and the WHO quality of life at 3 months and 6 months after surgery.DiscussionThe trial aims to investigate whether endoscopic evacuation and stereotactic aspiration could improve the outcome of supratentorial HICH compared with craniotomy. The trial will help to determine the best surgical method for the treatment of supratentorial HICH.Trial registrationClinicalTrials.gov, ID: NCT02811614. Registered on 20 June 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2041-1) contains supplementary material, which is available to authorized users.

Stereotactic Catheter Drainage Versus Conventional Craniotomy for Severe Spontaneous Intracerebral Hemorrhage in the Basal Ganglia

“…Traditional frontotemporal craniotomy was used to remove the hematoma via cortical fistula or separation of the lateral fissure, and the drainage tube (Yangzhou Xinxing silicone factory) was retained in the hematoma cavity. Finally, the bone flap was removed 13 .…”

Open and minimally invasive surgery for hypertensive intracranial hemorrhages. Surgey outcomes of 500 patients

“…38 (14) 11 (11) 71 ЭА ВМГ выполняли через фрезевое отверстиеу 113 (86,3 %), трефинационное отверстие диаметром 3 см -у 9 (6,9 %) или костно-пластическую трепанацию -у 9 (6,9 %) из 131 больного в зависимости от разновидности применяемой методики: у 18 (13,7 %) из 131 больного эндоскопическое удаление ВМГ проводили через широкие порты, что было выполнимо только при размере трепанационного окна не менее 3 см в диаметре. ЭА ВМГ осуществляли при следующих разновидностях методики: через троакар эндоскопа -у 96 (73,3 %) больных, через широкие эндоскопические порты (Vicor диаметром 12 и 21 мм) -у 18 (13,7 %), через узкие эндоскопические порты (8 мм) -у 17 (13,0 %) больных [19].…”

“…Вместе с тем в ряде работ были продемонстрированы возможности улучшения исходов у больных благодаря хирургическому лечению [7][8][9]. Cравнительных исследований, демонстриру ющих результаты открытых операций (ОО), пункционной аспирации и локального фибринолиза (ПФ) и эндоскопической аспирации (ЭА) ВМГ, немного, и до настоящего времени вопрос о приоритете того или иного метода остается открытым [11][12][13][14][15].…”

Dexmedetomidine is superior to midazolam for sedation and cerebral protection in postoperative hypertensive intracerebral hemorrhage patients: a retrospective study

“…Hypertensive intracerebral hemorrhage (HICH) refers to rupture and hemorrhage of small arteries because of pathological changes in the brain caused by prolonged hypertension and cerebral arteriosclerosis. 1 Among the various causes of non-traumatic intracerebral hemorrhage, hypertension accounts for approximately 60% of cases. HICH is one of the most serious complications of hypertension 2 and is common in 50- to 60-year-old patients, and the incidence in men is slightly higher than that in women.…”