手术后数据结果 Post-operative Data-Results
1.  对一般健康状况，摄入的食物和水进行了记录。术后恢复期小于24小时。在整个研究随访期中均发现健康状况是良好的，包括排泄在内的生理条件正常。参与研究的兽医每日对试验猪进行监测，没有发现任何不适体征，发热或疾病。相反地，试验猪在手术后的第二天便恢复了正常习性。试验猪的粪便特性与未接受手术的同年龄同体重猪相比未发生变化。研究人员认为吻合在临床上是有效的。
1.  General health, food and water intake were recorded.  Recovery period was less than 24h. Good health and normal physiological condition including excretions were observed during the entire study follow-up. The attending veterinarian staff, that monitored the pigs on a daily basis, did not observe any signs of discomfort, fever, or illness of the pigs. On contrarily, the pigs returned to normal habits the day after surgery. Feces habits were un-change from pigs that were not operated with the same age and weight. The staff concluded that the anastomoses were clinically functioning.
2.  根据试验方案中所述，由兽医人员负责在试验猪的粪便中搜寻吻合环以确认其是否被排出。7至10天后在粪便中发现了吻合环。这一时间在预期的间隔期内，并且与CAC设备是一致的。
对排出的吻合环予以回收并通过肉眼进行了检查。结果发现每个吻合环都是完好无损的，没有发现一个吻合环脱落或损坏。
2.  As instructed in the test protocol, the veterinary staff verified the expulsion of the CAR rings by finding the rings in the pig fecal excretions. The rings were found in the stool after 7 to 10 days.  This was within the predefined time frame interval and is the same as with the CAC device.
Expelled rings were retrieved and evaluated by visual examination.  Each CAR ring was found to be intact and in excellent condition.  Neither Ring dismantling nor deterioration were observed.
3.  试验通过了对设备的性能评估。在下表中对包含记录参数的性能总体评估进行了总结：
3.  Performance evaluation of the devices pass. The overall evaluation of performance, including the recorded parameters is summarized in the following table:

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根据记录，设备操作是十分顺利的。没有一件设备未能完成整个操作步骤，操作中也未发生任何故障。在完成了装填，吻合环连接，穿过吻合线和砧环后，肠段被完整地连接了起来。吻合设备可顺利收回，两层组织重叠吻合。
Smooth operation of the devices was recorded. None of the devices failed in full sequence operation and no malfunction was observed. Loading, connection of rings, cutting through staples and anvil ring was done, intestine perfect connection was observed. Device release was easy and two tissue bagels were obtained.
4. 吻合质量极佳。以下图片显示了不同时间段的吻合情况。
4. Anastomoses quality were excellent. Provided below pictures of anastomoses in different time.
5. 对吻合的组织病理学评估
5. Histopathology Evaluation of the Anastomosis
由一名独立的专家撰写一份独立组织病理学报告。
组织病理学评估由独立的组织病理学实验室进行。在动物的肠组织内未发现任何与CAR有关的组织损伤或异常反应。此外，观察到了手术后组织反应和主动愈合过程中典型的正常炎症过程。在粘膜下层和外肌层中发现了预期的肉芽组织形成（活动疤痕）证据。
完整的组织学报告附在CRF之后。
An independent histopathology report was written by an independent expert.
An independent histopathology laboratory performed the histopathology evaluation. No tissue damage or abnormal reactions to the host intestinal tissues, which can be related to the CAR were observed. Moreover, a normal inflammation process typical to postoperative tissue reaction and active healing process was observed. The expected evidence of granulation tissue formation (active scarring) in the submucosa and the muscularis externa was noted.
The complete histology reports are attached to the CRF.
6.  在时间点 0对每一只动物都进行了爆裂压力值的测定， 而在以下时间点上则至少对一只动物进行了测定：
6.  Burst pressure measurements were measured in each animal on time 0 and for a minimum of one animal each on the following time points:
? 手术操作后2周
? 2 weeks post-procedure
? 手术操作后一个月，而且
? one month post procedure, and
爆裂压力值是较高的，足以确保吻合的稳定与安全。
The burst pressure values were high and sufficient to assure a patent and secure anastomosis.