Abstract
Minimally invasive surgery (MIS) has been repeatedly evaluated in patients with ICH as a promising procedure for improved survival and functional outcome. Among MIS techniques, endoscopic surgery (ES) has shown superior efficacy for ICH removal due to rapid clot evacuation and immediate bleeding control. However, the results of ES are still uncertain due to insufficient data. In this study, participants with spontaneous supratentorial ICH who were indicated for surgery were randomly assigned (1:1) to undergo ES or conventional craniotomy (CC) between March 2019 and June 2022. The primary outcome was a difference in favorable modified Rankin Scale (mRS) outcome (0 to 3) at 180-day follow-up evaluated by blind assessors. There were 188 participants, 95 in the ES group and 93 in the CC group, who completed the trial. At 180-day follow-up, 46 (48.4%) participants in the ES group achieved favorable outcomes, compared to 33 (35.5%) in the CC group (risk difference [RD] 12.9, 95% CI − 1.1–27.0, p = 0.07). After covariate adjustment, the difference was slightly higher and significant (adjusted RD 17.3, 95% CI [4.6–30.0], p = 0.01). Moreover, the ES group had less operative duration and less intraoperative blood loss than the CC group. Clot evacuation rate and complications were similar between the two groups. Subgroup analyses showed a potential benefit of ES in age < 60 years, time to surgery ≥ 6 h, and deep ICH. This study showed that ES was safe and effective in ICH removal and provided a better functional outcome compared to CC.
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The participants of this study did not give written consent for their data to be shared publicly, so due to the sensitive nature of the research, supporting data is not available.
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Acknowledgements
The authors wish to thank Dr. Tadashi Watanabe, Department of Neurosurgery, Aichi Medical University, Nagakute, Aichi, Japan, for the supervision of the endoscopic technique for clot removal.
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This study was supported by a grant from the Faculty of Medicine, Thammasat University, Thailand. Grant number: TP.2–05/2565.
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All authors contributed to the study conception and design. Material preparation, data collection, and analysis were performed by Raywat Noiphithak, Vich Yindeedej, Warot Ratanavinitkul, and Gahn Duangprasert. The first draft of the manuscript was written by Raywat Noiphithak and Vich Yindeedej. This study was conducted under the supervision of Pree Nimmannitya, M.D., and Pornchai Yodwisithsak, M.D. Raywat Noiphithak read and approved the final manuscript on behalf of all authors.
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This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Human Research Ethic Committee of Thammasat University No. 1 on February 5, 2019 (MTU-EC-SU-2–241/61). The authors obtained consent from all participants for their participation in this research study.
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Noiphithak, R., Yindeedej, V., Ratanavinitkul, W. et al. Treatment outcomes between endoscopic surgery and conventional craniotomy for spontaneous supratentorial intracerebral hemorrhage: a randomized controlled trial. Neurosurg Rev 46, 136 (2023). https://doi.org/10.1007/s10143-023-02035-y
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DOI: https://doi.org/10.1007/s10143-023-02035-y