Minilap辅助经脐单孔腹腔镜下胆囊切除术的临床应用研究

吴攀1,李瑞斌2,万智恒2

(1.内蒙古科技大学包头医学院,内蒙古 包头 014000;2.包头医学院第一附属医院 普外一科,内蒙古 包头 014010)

摘 要 目的:探讨Minilap辅助下经脐单孔腹腔镜下胆囊切除术的可行性。方法:随机选取2015年1月—2015年12月包头医学院第一附属医院普外一科住院胆囊结石、胆囊息肉患者40例,按照自愿的原则分为对照组与观察组,每组20例,分别行经脐单孔腹腔镜胆囊切除术(对照组)与Minilap辅助经脐单孔腹腔镜胆囊切除术(观察组)。比较两组患者的相关临床指标。结果:40例腹腔镜手术均获成功,无中转开腹。与对照组比较,观察组平均手术时间(29.90 min vs.19.10 min,P=0.000)与术中出血量(4.90mL vs.8.05mL,P=0.000)明显减少;术后住院时间、疼痛评分、术后使用镇痛药物、对瘢痕满意度方面两组间均无统计学差异(均P>0.05)。术后随访10~18个月,患者术后恢复良好,Minilap穿刺点无明显疤痕。结论:Minilap辅助下经脐腹腔镜胆囊切除术安全可行、术后美容效果好,降低了手术难度,值得临床应用。

关键词 胆囊切除术,腹腔镜;自然腔道内镜手术;最小侵入性外科手术

胆囊结石是普外科的常见病、多发病,特别是在内蒙地区,由于生活习惯和饮食因素,胆囊结石更是高发。因此,胆道疾病的外科治疗在本地区的开展较为普遍。由于传统三孔腹腔镜手术需另在剑突下及右侧肋弓下缘打孔,增加了术后疼痛程度,患者常对切口瘢痕增加而不满意,而单孔腹腔镜胆囊切除术虽减少了三孔腹腔镜手术带来的上述缺点,但术中腹腔镜与器械均处于平行状态,所看到的图像是器械间的单层面,增加了手术操作的难度[1-2],从而导致手术时间相对延长,进而增加了手术、麻醉的风险。为了解决上述问题,本课题组引进了一种新型迷你抓钳——Minilap抓钳,在经脐单孔腹腔镜胆囊切除术中加用Minilap抓钳予以辅助,现已完成手术20例,术后临床效果满意,现报道如下。

1 资料与方法

1.1 临床资料

随机选取2015年1月—2015年12月包头医学院第一附属医院普外一科住院胆囊结石、胆囊息肉患者40例,按自愿的原则分为对照组和观察组,各20例。对照组20例行经脐单孔腹腔镜胆囊切除术,其中男5例,女15例;年龄26~65岁。观察组20例行Minilap辅助下经脐单孔腹腔镜手术20例,其中男2例,女18例;年龄25~70岁。以上患者均无手术禁忌证。术前采取自愿选择上述两组术式,并在手术同意书上签字。

1.2 操作装置及器械

全套德国STORZ腹腔镜设备,全套单孔腹腔镜操作器械,Minilap抓钳(美国Stryker公司生产,直径为2.3 mm),可吸收夹(美国强生公司)。

1.3 手术方法

1.3.1 对照组 采用静脉全身麻醉,麻醉起效后,患者采取头高脚低、左侧倾斜15°体位;取脐部上缘打口,建立人工气腹后置入三通道套管,套管内置入腹腔镜及分离钳等相关器械。显露并解剖胆囊三角,确定胆囊管,近端上可吸收夹远端上钛夹后离断,确定胆囊动脉后,上可吸收夹予以切断,用电钩将胆囊从肝下缘胆囊床分离,电钩电凝处理创面予以止血,胆囊自脐孔处取出,仔细缝合脐部切口。

1.3.2 观察组 麻醉、患者体位、术者及助手站位、切口选择及建立气腹方法均与对照组相同,二通道套管内置入腹腔镜和腹腔镜器械,在腔镜直视下取右侧肋缘下2cm穿剌进Minilap抓钳以协助显露或牵拉胆囊。暴露胆囊后显露并解剖胆囊三角;确定胆囊管,近端上可吸收夹远端上钛夹后离断,确定胆囊动脉后,上可吸收夹予以切断,用电钩将胆囊从肝下缘胆囊床分离,电钩电凝处理创面予以止血,胆囊自脐孔处取出,仔细缝合脐部切口。Minilap穿刺处予以压迫止血,对和皮肤,无需缝合。

1.4 观察指标

观察并记录两种术式的手术时间、术中出血量、术后住院时间、术后疼痛程度、术后腹壁瘢痕满意度,术后疼痛程度采用VAS疼痛评分法(图1),腹壁瘢痕满意度采用出院后电话或复诊随访方式进行。

图1 VAS疼痛评分标准
Figure 1 VAS scale criteria for pain evaluation

1.5 术后随访方法

术后随访10~18个月,通过电话、门诊复诊等方式对腹壁瘢痕满意度进行随访统计。

1.6 统计学处理

用SPSS 21.0对数据进行处理分析,计量资料采用均数±标准差表示,两组间比较运用采用t检验,计数资料采用χ2检验。

2 结 果

2.1 对照组与观察组围手术期相关指标比较

两组患者手术均获成功,两组手术时间相比,观察组手术时间明显短于对照组,差异有统计学意义(P<0.05);两组术中出血量比较,观察组术中出血量小于对照组,差异有统计学意义(P<0.05);两组术后住院时间、疼痛评分差异均无统计学意义(均P>0.05)(表1)。

表1 两组围手术期相关指标比较(±s)
Table 1 Comparison of the perioperative variables between the two groups ±s)

指标 对照组(n=20)观察组(n=20) t P手术时间(min) 29.90±1.55 19.10±1.74 20.684 0.000术中出血量(mL) 8.05±0.83 4.90±0.64 13.480 0.000术后住院时间(d) 3.50±0.51 3.25±0.55 1.486 0.145疼痛评分(分) 2.25±0.97 1.90±1.02 1.113 0.273

2.2 两组患者术后应用镇痛药物情况比较

通过对照组与观察组患者镇痛药物使用率情况统计分析,对照组为20.0%,观察组为15.0%,两组之间相比,差异无统计学意义(P>0.05)(表2)。

表2 两组患者术后应用镇痛药物情况比较[n(%),n=20]
Table 2 Comparison of the postoperative analgesic requirements between the two groups [n (%),n=20]

组别 使用 未使用对照组 4(20.0) 16(80.0)观察组 3(15.0) 17(85.0)χ2 0.173 P 0.677

2.3 两组患者术后腹壁瘢痕满意度比较

通过术后随访统计显示,观察组腹壁瘢痕满意度为85%,对照组腹壁瘢痕满意度为90%,两组之间差异无统计学意(P>0.05)(表3)(图2)。

表3 两组患者术后腹壁瘢痕满意度比较[n(%),n=20]
Table 3 Comparison of the degree of satisfaction for postoperative scars between the two groups [n (%),n=20]

组别 满意 不满意对照组 18(90) 2(10)观察组 17(85) 3(15)χ2 0.229 P 0.633

图2 两组术后疤痕情况比较
Figure 2 Comparison of the postoperative scars

3 讨 论

胆囊切除术是治疗胆囊息肉和胆囊结石的有效方法。腹腔镜胆囊切除术具有手术时间短、创伤小、术后恢复时间快、并发症低等优点[3],近年来逐渐取代开腹胆囊切除术,成为胆囊切除术的首选术式[4]。近年来,随着科学技术的发展及外科技术的不断提高,以腹腔镜胆囊切除为例,经历了从经典的四孔手术到三孔手术[5]、二孔法[6]、单孔法[7] 、经自然腔道胆囊切除术[8-10] 的发展过程。

在行腹腔镜胆囊切除术的同时,如何做到更加微创、甚至无瘢痕一直是外科医师不断研究的重点。更多的外科医生在手术入路方面进行不断的探究,单孔腹腔镜手术(laparoendoscopic single-site surgery,LESS)以及经自然腔道手术(natural orifice transluminal endoscopic surgery,NOTES)便应运而生[11]。但众多研究者认为目前施行NOTES手术的器械不够完善,难以处理术中的突发情况,如出血、腹腔脏器的损伤等,其术中的安全性无法得到有效保障,这也是目前NOTES手术进展得到限制的最大原因,因此,对NOTES专用器械的研究与发展仍是解决相关问题的关键所在[12-13],以上这些原因限制了NOTES手术的发展。为了追求更加安全的手术方式,近年来单切口腹腔镜手术中经脐单孔腹腔镜手术(transumbilical laparoendoscopic single-site surgery,U-LESS)[14]凭借手术安全性高、可操作性高等优点得到迅速发展。首例经脐单孔腹腔镜胆囊切除术是Navarra教授等[15]于1997年率先完成,当时为了更好的显露手术视野、便于术中更好的操作,术中采用经右上腹穿刺固定2~3根牵引线来悬吊胆囊,并且要用直径为2 mm的微型腹腔镜手术器械来辅助完成手术,这也是第一例报道使用针形腹腔镜器械的临床研究。在此基础上,Cuesta等[16]使用了直径约1 mm的克氏针经右肋下缘穿刺进入腹腔后用于协助牵引胆囊,顺利完成了10例单孔腹腔镜胆囊切除术。这些微型器械的应用也是Minilap器械产生的雏形。最初的针形腹腔镜器械硬度比较低、抓持力比较差、易磨损,在初期应用于临床过程中给手术带来了一定的困难,经过不断地创新和发展,新一代Minilap器械的出现恰好解决了上述问题。

本次研究,对照组与观察组术后住院时间比较,差异无统计学意义,对手术时间及术中出血量进行统计分析后显示,两组之间差异均有统计学意义,原因在于对照组操作难度大,由于术中腹腔镜镜头和器械均经脐部进入腹腔,无法避免的使镜头与器械之间相互遮挡和碰撞,从而导致手术时间及出血量增加,影响手术的进度,给术者带来了极大的不适应感[17-19]。而Minilap抓钳具有硬度高、开口大、抓持胆囊力度强的特点,能使胆囊充分暴露,缩短手术时间、进而减少术中出血量,弥补了单孔腹腔镜的上述缺点,降低了单孔腹腔镜的手术难度。

术后使用镇痛药物方面,本资料两组统计数据差异无统计学意义,原因在于Minilap抓钳无需穿刺器可直接刺入腹腔,避免术中损伤表皮神经及腹壁神经[20],与对照组相比,Minilap所造成的疼痛几乎忽略不计。

通过对对照组与观察组术后腹壁瘢痕满意度的统计结果显示,两者之间差异无统计学意义。原因在于Minilap抓钳属超细器械(直径为2.3 mm),符合单孔腹腔镜技术专家共识[21]:即允许采用除脐孔或脐缘以外直径3 mm以下戳口作为辅助操作点[22-23]。因此,经Minilap辅助下经脐单孔腹腔镜胆囊切除术术后右肋下刺入点无明显瘢痕,满足了患者对于单孔腹腔镜手术美容的需求[24-25]

综上所述,Minilap辅助下经脐单孔腹腔镜胆囊切除术缩短了手术时间、减少了术中出血量,降低了手术难度,更易于被广大医生及患者接受,具有广泛的推广价值。

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Clinical application of Minilap-assisted single-port transumbilical laparoscopic cholecystectomy

WU Pan1,LI Ruibin2,WAN Zhiheng2
(1.Baotou Medical College,Inner Mongolia University of Science and Technology,Baotou 014000,China; 2.The First Department of General Surgery,the First Affiliated Hospital,Baotou Medical College,Baotou 014010,China)

Abstract Objective: To investigate the feasibility of Minilap-assisted single-port transumbilical laparoscopic cholecystectomy.Methods: Forty patients with gallbladder stones or gallbladder polyps admitted in the First Department of General Surgery of the First Affiliated Hospital,Baotou Medical College,between January and December of 2015 were randomly selected,and then divided into control group and observation group according to their preferences,with 20 cases in each group.Patients in control group underwent single-port transumbilical laparoscopic cholecystectomy and those in observation group received Minilap-assisted single-port transumbilical laparoscopic cholecystectomy.The main clinical variables between the two groups of patients were compared.Results: Laparoscopic surgery was successfully performed in all 40 patients,without any open conversion.In observation group compared with control group,the average operative time (29.90 min vs.19.10 min,P=0.000)and intraoperative blood loss (4.90mL vs.8.05mL,P=0.000) were significantly decreased,while other variables showed no significant difference (all P>0.05),including the length of postoperative hospital stay,postoperative pain scores,analgesic consumption,and degree of patient satisfaction for surgical scars.Postoperative followup was conducted for 10 to 18 months,all patients recovered uneventfully,and no obvious scar was noted in the puncture site of Minilap.Conclusion: Minilap-assisted single-port transumbilical laparoscopic cholecystectomy is safe and feasible,has favorable cosmetic results and it helps to reduce surgical difficulty,so it is recommended to be used in clinical practice.

Key words Cholecystectomy,Laparoscopic; Natural Ori fi ce Endoscopic Surgery,Minimally Invasive Surgical Procedures

CLC number: R657.4

中图分类号:R657.4

doi:10.3978/j.issn.1005-6947.2017.02.006

http://dx.doi.org/10.3978/j.issn.1005-6947.2017.02.006

Chinese Journal of General Surgery,2017,26(2):166–171.

基金项目:内蒙古包头市社会发展科技支撑项目(2015S2004-5-20)。

收稿日期:2016-08-12;

修订日期:2017-01-15。

作者简介:吴攀,内蒙古科技大学包头医学院硕士研究生,主要从事普通外科疾病微创化治疗方面的研究。

通信作者:万智恒,Email: 15849472388@163.com

(本文编辑 姜晖)

本文引用格式:吴攀,李瑞斌,万智恒.Minilap辅助经脐单孔腹腔镜下胆囊切除术的临床应用研究[J].中国普通外科杂志,2017,26(2):166–171.doi:10.3978/j.issn.1005-6947.2017.02.006

Cite this article as: Wu P,Li RB,Wan ZH.Clinical application of Minilap-assisted single-port transumbilical laparoscopic cholecystectomy[J].Chin J Gen Surg,2017,26(2):166–171.doi:10.3978/j.issn.1005-6947.2017.02.006

·基础研究·