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普拉斯塔在腹腔镜结直肠手术中的安全性和可行性(可行性研究)。

Safety and feasibility of PuraStat in laparoscopic colorectal surgery (Feasibility study).

机构信息

Clinica Chirurgica, Università Politecnica delle Marche, Ancona, Italy.

Colorectal Depertment, King's College Hopital, London, UK.

出版信息

Minim Invasive Ther Allied Technol. 2021 Dec;30(6):363-368. doi: 10.1080/13645706.2020.1739711. Epub 2020 Mar 14.

Abstract

INTRODUCTION

Haemorrhage remains a major cause of morbidity and death in all surgical specialties. The aim of this study was to analyse the feasibility of PuraStat, a new synthetic haemostatic device, made of self-assembling peptides in laparoscopic colorectal surgery.

MATERIAL AND METHODS

This was a prospective observational non-randomised study. Consecutive patients undergoing laparoscopic colorectal surgery were enrolled. Inclusion criterion was the need employ a secondary method of haemostasis when traditional methods such as conventional pressure or utilization of energy devices to control the bleeding were either insufficient or not recommended.

RESULTS

Twenty patients were enrolled. The mean time to apply the product was 40 secs (±17 secs), whereas the mean time to achieve haemostasis was 17.5 secs (±3.5 secs). There were no post-operative complications in this cohort of 20 patients. Mean operative time overall was 185 mins (±45.2 mins). None of the patients experienced delayed post-operative bleeding and the mean hospital stay was five days (±3,4).

CONCLUSIONS

We demonstrated that PuraStat can be easily used in laparoscopic surgery and it is a safe, effective haemostatic agent. This is a feasibility study and additional controlled studies would be useful in the future.

摘要

简介

出血仍然是所有外科专业发病率和死亡率的主要原因。本研究的目的是分析一种新型的自组装肽合成止血装置 PuraStat 在腹腔镜结直肠手术中的应用可行性。

材料和方法

这是一项前瞻性观察性非随机研究。连续入组接受腹腔镜结直肠手术的患者。纳入标准为当传统方法(如常规压迫或使用能量设备控制出血)不足或不推荐时,需要使用辅助止血方法。

结果

共纳入 20 例患者。应用产品的平均时间为 40 秒(±17 秒),而达到止血的平均时间为 17.5 秒(±3.5 秒)。这 20 例患者均无术后并发症。总体手术时间为 185 分钟(±45.2 分钟)。无患者发生术后迟发性出血,平均住院时间为 5 天(±3.4 天)。

结论

我们证明了 PuraStat 可以在腹腔镜手术中轻松使用,并且是一种安全有效的止血剂。这是一项可行性研究,未来还需要更多的对照研究。

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