Commentary: Efficacy and Safety of Minimally Invasive Surgery With Thrombolysis in Intracerebral Haemorrhage Evacuation (MISTIE III): A Randomized, Controlled, Open-Label, Blinded Endpoint Phase 3 Trial

Rationale and hypothesisSurgical removal of spontaneous intracerebral hemorrhage may reduce secondary destruction of brain tissue. However, large surgical trials of craniotomy have not demonstrated definitive improvement in clinical outcomes. Minimally invasive surgery may limit surgical tissue injury, and recent evidence supports testing these approaches in large clinical trials.Methods and designMISTIE III is an investigator-initiated multicenter, randomized, open-label phase 3 study investigating whether minimally invasive clot evacuation with thrombolysis improves functional outcomes at 365 days compared to conservative management. Patients with supratentorial intracerebral hemorrhage clot volume ≥ 30 mL, confirmed by imaging within 24 h ofknown symptom onset,and intact brainstem reflexes were screened with a stability computed tomography scan at least 6 h after diagnostic scan. Patients who met clinical and imaging criteria (no ongoing coagulopathy; no suspicion of aneurysm, arteriovenous malformation, or any other vascular anomaly; and stable hematoma size on consecutive scans) were randomized to either minimally invasive surgery plus thrombolysis or medical therapy. The sample size of 500 was based on findings of a phase 2 study.Study outcomesThe primary outcome measure is dichotomized modified Rankin Scale 0–3 vs. 4–6 at 365 days adjusting for severity variables. Clinical secondary outcomes include dichotomized extended Glasgow Outcome Scale and all-cause mortality at 365 days; rate and extent of parenchymal blood clot removal; patient disposition at 365 days; efficacy at 180 days; type and intensity of ICU management; and quality of life measures. Safety was assessed at 30 days and throughout the study.

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Efficacy and safety of condylectomy with minimally invasive surgery in the treatment of interdigital corns of the lesser toes compared to conservative treatment

Journal of Foot and Ankle Research ◽

10.1186/s13047-021-00460-0 ◽

2021 ◽

Vol 14 (1) ◽

Author(s):

Luis M. Marti-Martinez ◽

Rubén Lorca-Gutierrez ◽

Salvador Pedro Sánchez-Pérez ◽

Jonatan Garcia-Campos ◽

Nadia Fernández Ehrling ◽

...

Keyword(s):

Minimally Invasive Surgery ◽

Surgical Treatment ◽

Treatment Group ◽

Conservative Treatment ◽

Minimally Invasive ◽

Functional Status ◽

Invasive Surgery ◽

Joint Stiffness ◽

Efficacy And Safety ◽

Clinical And Functional Status

Abstract Background Minimally invasive surgery (MIS) procedures cause less trauma to the patient and might improve recovery. This study aimed to determine the efficacy and safety of condylectomy with MIS to treat interdigital corns of the lesser toes. Methods This prospective cohort study was conducted in seven podiatry centers. Patients with interdigital corns of the lesser toes, progressing for more than a year, with one or more recurrences in the last year following conservative treatments were eligible. The recruited patients were classified according to their treatment: conservative or surgical (condylectomy with MIS) and were compared. Patient satisfaction, pain, the clinical and functional status of the foot and the appearance of sequelae were assessed at 3 and 6 months after treatment. Results At 6 months, patients in the surgical treatment group showed no pain on pressure, which significantly differed from the conservative treatment group (p < 0.001). They also improved clinical and functional status of the foot, reaching values comparable to those of the standard population. No paresthesia, joint stiffness or instability, toe malalignment, or corn transfer to a contiguous site resulted from the surgical treatment. Conclusions Condylectomy with MIS is effective and safe to treat interdigital corns of the lesser toes.

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