Purpose

The study aimed to evaluate the feasibility and safety of a new trans-anal rectoscopic-assisted minimally invasive surgery (ARAMIS) platform to treat rectal lesions.

Methods

ARAMIS was first compared with two transanal minimally invasive surgery platforms (SILS Port and GelPOINT Path) on human cadavers. Surgeons with different experience performed running sutures at different distances, at four quadrants, using the three platforms and gave a score to visibility, safety, and maneuverability. ARAMIS was then utilized on patients affected with rectal neoplasia who met the inclusion criteria. Patients and tumor characteristic and results were prospectively collected. The follow-up examinations included proctoscopy at 3, 6, and 12 months.

Results

According to surgeons’ scores, ARAMIS improves visibility and safety with respect to other platforms for distances beyond 10 cm. The procedure, which lasted an average of 59 min, was successfully carried out in 14 patients. No intraoperative or postoperative complications were reported. The mean tumor size was 3 cm; they were located a mean of 11 cm from the anal verge. Complete removal of the lesion was possible in 13/14 patients. There was one case of adenoma recurrence at follow-up.

Conclusion

Study results showed that ARAMIS, which is equipped with an adjustable rectoscope, can be considered a safe, effective platform for transanal surgery. The rectoscope protects the rectum during the procedure, a particularly important consideration when proximal rectal lesions are being treated. Further clinical studies are warranted to confirm these encouraging results.

中文翻译：

---

经肛门直肠镜辅助微创手术（ARAMIS）的评估：经肛门手术的新平台。

目的

该研究旨在评估新型经肛门直肠镜辅助微创手术（ARAMIS）平台治疗直肠病变的可行性和安全性。

方法

首先将ARAMIS与人类尸体上的两个经肛门微创手术平台（SILS Port和GelPOINT Path）进行了比较。具有不同经验的外科医生使用这三个平台在四个象限以不同的距离进行缝合，并对可见性，安全性和可操作性进行了评分。然后将ARAMIS用于符合纳入标准的患有直肠肿瘤的患者。前瞻性收集患者和肿瘤特征及结果。随访检查包括3、6和12个月的直肠镜检查。

结果

根据外科医生的评分，ARAMIS相对于其他平台而言，在距离超过10厘米时，可以提高可见性和安全性。该过程平均持续59分钟，已成功地对14例患者进行了手术。没有术中或术后并发症的报道。平均肿瘤大小为3厘米；它们的位置距离肛门边缘11厘米。13/14例患者有可能完全清除病变。随访中有1例腺瘤复发。

结论

研究结果表明，配备有可调式直肠镜的ARAMIS可被视为安全有效的经肛门手术平台。直肠镜可在手术过程中保护直肠，这在治疗近端直肠病变时尤为重要。有必要进行进一步的临床研究以证实这些令人鼓舞的结果。