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评价一种喷雾型新型糊精水凝胶防粘连屏障在猪子宫角粘连模型腹腔镜下的效果。

Evaluation of a Spray-type, Novel Dextrin Hydrogel Adhesion Barrier Under Laparoscopic Conditions in a Porcine Uterine Horn Adhesion Model.

机构信息

Terumo Corporation, R&D Center, Kanagawa, Japan.

Terumo Corporation, R&D Center, Kanagawa, Japan.

出版信息

J Minim Invasive Gynecol. 2018 Mar-Apr;25(3):447-454. doi: 10.1016/j.jmig.2017.09.023. Epub 2017 Oct 10.

Abstract

STUDY OBJECTIVE

To establish a porcine uterine horn adhesion model that mimicked laparoscopic procedures and use it to investigate the effect of a spray-type, novel dextrin hydrogel adhesion barrier (AdSpray; Terumo Corporation, Tokyo, Japan) on postsurgical adhesions.

DESIGN

A single-blind randomized controlled trial (Canadian Task Force Classification I).

SETTING

A Certified animal research facility.

SUBJECTS

Sixteen female pigs.

INTERVENTIONS

All animals underwent laparoscopically assisted adhesion-inducing surgery. The uterine horns and the peritoneum of the pelvic sidewall were injured. In the experimental group, AdSpray was applied to the injured site, and the handling of the sprayer was assessed. At 28 ± 1 days after surgery, animals were sacrificed, and adhesions at the injured site were evaluated. Uterine horn suture sites were examined under a light microscope to assess healing of the incised wound, the inflammatory reaction, abscess, and the foreign body reaction to the surgical suture.

MEASUREMENTS AND MAIN RESULTS

The control group showed severe adhesions over the entire surface interface at the uterine horn suture sites and peritoneal resection site. Compared with the control treatment, AdSpray exhibited a higher percentage of adhesion-free sites (p < .001) and reduced the total adhesion score (p < .001). In the AdSpray group, no inflammation or abscess formation was observed on histopathological examination, and ideal healing of the suture sites was confirmed in all cases.

CONCLUSION

Based on the results of the present study, the novel dextrin hydrogel shows excellent adhesion prevention and can be easily applied during laparoscopy using a dedicated sprayer.

摘要

研究目的

建立一种模拟腹腔镜手术的猪子宫角粘连模型,并研究新型喷雾型糊精水凝胶粘连隔离剂(AdSpray;日本东京 Terumo 公司)对术后粘连的影响。

设计

单盲随机对照试验(加拿大任务组分类 I 级)。

设置

经认证的动物研究设施。

受试者

16 头雌性猪。

干预措施

所有动物均接受腹腔镜辅助粘连诱导手术。子宫角和骨盆侧壁的腹膜受伤。在实验组,将 AdSpray 应用于受伤部位,并评估喷雾器的操作。术后 28±1 天,处死动物,评估受伤部位的粘连情况。在光镜下检查子宫角缝合部位,评估切口愈合、炎症反应、脓肿和对手术缝线的异物反应。

测量和主要结果

对照组在子宫角缝合部位和腹膜切除部位的整个表面界面均出现严重粘连。与对照组相比,AdSpray 表现出更高比例的无粘连部位(p<.001),且总粘连评分降低(p<.001)。在 AdSpray 组,组织病理学检查未见炎症或脓肿形成,所有病例的缝合部位均愈合良好。

结论

根据本研究结果,新型糊精水凝胶具有优异的防粘连效果,可在腹腔镜手术中使用专用喷雾器轻松应用。

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