The STICH (Surgical Trial in Lobar Intracerebral Haemorrhage) I and II trials randomized patients with spontaneous intracerebral hemorrhage (ICH) to early surgery or initial conservative treatment. Both were nonsignificant; possibly because surgery has minimal effect on recovery, or because surgery benefits some and harms others.
Gregson et al., introduced a new nonparametric method of analysis. The method is then applied to data from a third trial, STITCH(Trauma) (Surgical Trial in Traumatic Intracerebral Haemorrhage), which addressed a similar surgical question in head-injured patients.
Data from 1541 patients from the STICH trials were analyzed using (1) standard meta-analysis of prognosis-based dichotomized outcome and prespecified standard subgroups of Glasgow Coma Scale (GCS): 3-8, 9-12, and 13-15; (2) new nonparametric regression of ranked Extended Glasgow Outcome Scale against ranked GCS and ranked volume; and (3) analysis (1) repeated using categories identified by analysis (2). Results- Standard meta-analysis showed more favorable outcomes, although nonsignificant, with surgery if presenting GCS was 9-12 (spontaneous ICH odds ratio, 0.70 [95% CI, 0.48-1.03; P=0.07]; traumatic odds ratio, 0.48 [95% CI, 0.18-1.26; P=0.14]). Ranked analysis showed a similar pattern of results for both spontaneous and traumatic ICH. Surgery was harmful for small lesions with increasing benefit for larger volumes. With GCS, surgery had little effect at either ends of the spectrum but suggested a beneficial effect in the range 10 to 13 (identified graphically). Repeating the meta-analysis with this categorization showed significant benefit for surgery (spontaneous odds ratio, 0.71 [95% CI, 0.51-1.00; P=0.05]; traumatic odds ratio, 0.16 [95% CI, 0.05-0.51; P=0.002]). Conclusions- The nonsignificant results observed in the STICH trials are because of mixing patients who benefit from surgery with those who are harmed. Patients with a GCS 10-13 or a large ICH are likely to benefit from surgery. Our analysis showed a similar effect on traumatic ICH/contusion data and promises to be a valuable tool. Clinical Trial Registration- URL: http://www.isrctn.com/ . Unique identifiers: ISRCTN19976990 (STITCH), ISRCTN22153967 (STICH II), and ISRCTN19321911 (STITCH[Trauma]) 1).
While it is accepted practice to remove extradural (EDH) and subdural haematomas (SDH) following traumatic brain injury, the role of surgery in parenchymal traumatic intracerebral haemorrhage (TICH) is controversial. There is no evidence to support Early Surgery in this condition.
OBJECTIVES: There have been a number of trials investigating surgery for spontaneous intracerebral haemorrhage but none for TICH. This study aimed to establish whether or not a policy of Early Surgery for TICH improves outcome compared with a policy of Initial Conservative Treatment.
DESIGN: This was an international multicentre pragmatic parallel group trial. Patients were randomised via an independent telephone/web-based randomisation service.
SETTING: Neurosurgical units in 59 hospitals in 20 countries registered to take part in the study.
PARTICIPANTS: The study planned to recruit 840 adult patients. Patients had to be within 48 hours of head injury with no more than two intracerebral haematomas greater than 10 ml. They did not have a SDH or EDH that required evacuation or any severe comorbidity that would mean they could not achieve a favourable outcome if they made a complete recovery from their head injury.
INTERVENTIONS: Patients were randomised to Early Surgery within 12 hours or to Initial Conservative Treatment with delayed evacuation if it became clinically appropriate.
MAIN OUTCOME MEASURES: The Extended Glasgow Outcome Scale (GOSE) was measured at 6 months via a postal questionnaire. The primary outcome was the traditional dichotomised split into favourable outcome (good recovery or moderate disability) and unfavourable outcome (severe disability, vegetative, dead). Secondary outcomes included mortality and an ordinal assessment of Glasgow Outcome Scale and Rankin Scale.
RESULTS: Patient recruitment began in December 2009 but was halted by the funding body because of low UK recruitment in September 2012. In total, 170 patients were randomised from 31 centres in 13 countries: 83 to Early Surgery and 87 to Initial Conservative Treatment. Six-month outcomes were obtained for 99% of 168 eligible patients (82 Early Surgery and 85 Initial Conservative Treatment patients). Patients in the Early Surgery group were 10.5% more likely to have a favourable outcome (absolute benefit), but this difference did not quite reach statistical significance because of the reduced sample size. Fifty-two (63%) had a favourable outcome with Early Surgery, compared with 45 (53%) with Initial Conservative Treatment [odds ratio 0.65; 95% confidence interval (CI) 0.35 to 1.21; p = 0.17]. Mortality was significantly higher in the Initial Conservative Treatment group (33% vs. 15%; absolute difference 18.3%; 95% CI 5.7% to 30.9%; p = 0.006). The Rankin Scale and GOSE were significantly improved with Early Surgery using a trend analysis (p = 0.047 and p = 0.043 respectively).
CONCLUSIONS: This is the first ever trial of surgery for TICH and indicates that Early Surgery may be a valuable tool in the treatment of TICH, especially if the Glasgow Coma Score is between 9 and 12, as was also found in Surgical Trial In spontaneous intraCerebral Haemorrhage (STICH) and Surgical Trial In spontaneous lobar intraCerebral Haemorrhage (STICH II). Further research is clearly warranted.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN 19321911 2).
Surgical treatment of traumatic intracerebral lesions was advanced in the late 19th and 20th centuries by several pioneer neurosurgeons, including Victor Horsley, Harvey Cushing, W H Jacobson, Hugh Cairns, and Walter Dandy.
In 2006 there was Level III 3):
Indications for surgical evacuation for TICH:
○ progressive neurological deterioration referable to the TICH, medically refractory IC-HTN, or signs of mass effect on CT
○ or TICH volume > 50cm3 cc or ml
○ or GCS = 6–8 with frontal or temporal TICH volume >20 cm3 with midline shift(MLS)≥5mm and/or compressed basalcisterns on CT.
● nonoperative management with intensive monitoring and serial imaging: may be used for TICH without neurologic compromise and no significant mass e ect on CT and controlled ICP.
Open craniotomy is the most widely studied surgical techniques in patients with supratentorial ICH. Other methods include endoscopic hemorrhage aspiration, use of fibrinolytic therapy to dissolve the clot followed by aspiration, and CT-guided stereotactic aspiration 6) 7).
Early decompressive hemicraniectomy (DH) with or without clot evacuation is feasible and safe for managing spontaneous ICH. The experience of Esquenazi et al. in a uncontrolled retrospective series, the largest such series in the modern era, suggests that it may be of particular benefit in patients with large non-dominant hemisphere ICH who are not moribund at presentation. These findings suggest that a prospective randomized trial of DH vs. craniotomy for ICH be conducted.
Over 7 years, DH was performed in 73 patients with clot evacuation in 86% and DH alone in 14%. The average ICH volume was 81 cc and the median DH surface area was 105 cm(2). 26 patients were comatose at initial presentation. Three-month functional outcomes were favorable in 29%, unfavorable in 44% and 27% of patients expired. Admission Glasgow Coma Scale (p=0.003), dominant hemisphere ICH location (p=0.01) and hematoma volume (p=0.002) contributed significantly to the outcome, as estimated by a multivariate analysis. Eight surgical complications occurred. 11).
The effective therapies for patients with sICH are still unclear, and the role of surgical treatment in sICH management is still controversial. Although some large trials did not show that surgery could benefit patients with sICH, some other studies suggested that some specific surgical strategies can have potential benefits to these patients. For a better understanding of the surgical treatment in patients with sICH, it is necessary to conduct a network meta-analysis to compare the effects of medical treatment and different surgical methods comprehensively.
METHODS AND ANALYSIS: This protocol has been reported following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Related studies until August 2018 will be searched in the following databases: PubMed, Embase, Scopus, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP and Wanfang. Randomised controlled trials and non-randomised prospective studies comparing at least two different interventions in patients with sICH will be included. Quality assessment will be conducted using Cochrane Collaboration's tool or Newcastle-Ottawa Scale based on their study designs. The primary outcome will be functional outcome and the secondary outcome will be mortality. Pairwise and network meta-analysis will be conducted using STATA V.14 (StataCorp, College Station, Texas, USA). Mean ranks and the surface under the cumulative ranking curve will be used to evaluate every intervention. Statistical inconsistency assessment, subgroup analysis, sensitivity analysis and publication bias assessment will be performed.
ETHICS AND DISSEMINATION: Ethics approval is not necessary because this study will be based on publications. The results of this study will be published in a peer-reviewed journal 12).