单孔腹腔镜（LESS）手术器械开发和单孔腹腔镜技术在泌尿外科临床应用性研究
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摘要
研究背景：
外科手术是医学治疗的一种重要手段,是一把“双刃剑”,离不开创伤的“制造”和“愈合”,对于手术“无创”和切口“美观”的追求成为外科手术“微创化”发展的动力。1987年法国里昂医生Mouret成功为患者施行腹腔镜下胆囊切除术,揭开了“微创”外科的新篇章。腹腔镜手术以其切口小、美观、组织损伤小、出血少、恢复快、术野清晰、操作精细等优势被医师和患者广泛接受,腹腔镜技术为微创外科领域带来了巨大变革,并在世界范围内得到迅速推广,在泌尿外科以及其它专科中迅速发展,1991年美国医生Clayman完成首例腹腔镜下肾切除,成功将腹腔镜技术引入泌尿外科领域。
进入21世纪以来,随着科学技术的进步,外科医师继续在腹腔镜技术上进行探索和创新。为了进一步减少手术创伤及达到更好的美容效果,有学者提出“无疤手术”的设想。在此背景下经自然腔道内镜手术(NOTES, natural orifice transluminal endoscopic surgery)问世,NOTES是指经自然腔道(胃、阴道、直肠或膀胱)置入软镜,通过管壁切口进入腹腔开展手术。虽然NOTES以乎是一种很有前途的新技术,动物实验也取得了一定的成功,但NOTES尚存在一些目前未能完全解决的问题,如：健康自然腔道损伤与腹壁软组织损伤的代价比；如何有效可靠的关闭自然腔道切口；自然腔道损伤的近、远期修复原理和过程；自然腔道手术可能导致腹腔污染；难以利用现有腹腔镜技术和器械；NOTES软性内镜过长及过多弯曲、操作困难等,因此NOTES技术目前仍处于临床探索阶段。
为了寻求可行的“无疤”手术,学者将目标转向了肚脐。脐是身体上唯一与生俱来的瘢痕,在脐部做一小切口,术后的瘢痕可隐藏于肚脐皱褶内,从而实现手术“无疤痕”化,在这种情况下单孔腹腔镜技术应运而生。Pelosi等于1992年报导首例经脐单孔腹腔镜下阑尾切除术,Navarra等于1997年报导了经脐单孔腹腔镜胆囊切除术。单孔腹腔镜在泌尿外科的应用始于2007年,Rane等在2007年报告了最早2例单孔腹腔镜泌尿外科手术,此后有学者陆续报道了经脐单孔腹腔镜肾切除术、根治性肾切除术、肾盂成形术、经膀胱单孔单纯前列腺切除术和活体供肾切取术等单孔腹腔镜手术。LESS术后的美容效果得到了广泛认可。在单孔腹腔镜手术开展的同时,各种命名方法层出不穷,为了使单孔腹腔镜手术更为规范,2008年7月成立了腹腔镜内窥镜单孔手术评估和研究组(LESSCAR),与会专家确定了单孔腹腔镜的统一命名——laparoendoscopic single-site surgery (LESS)。
随着单孔腹腔镜技术的开展,一些问题浮出水面：1.有悖传统腹腔镜手术的基本要求——“操作三角”,使得医生的操作不符合人体工学设计原理,极易疲劳；2.采用传统器械时,由于所有器械经过单一切口进行操作,“筷子效应”导致各器械之间互相碰撞和“打架”的现象时常发生；3.暴露不好,由于可同时使用的操作器械有限,对手术部位的暴露很困难；4.一些学者质疑单孔腹腔镜手术的安全性和有效性。
本课题拟针对上述问题进行研究,设计合理的单孔腹腔镜开口器、预弯器械,开展LESS泌尿外科手术,验证LESS手术的可行性、安全性和临床疗效。
目的：
1.根据单孔腹腔镜技术要求,设计能够供给临床实践和模拟训练使用的单孔腹腔镜开口器。
2.解决单孔腹腔镜手术过程中常见的使用传统腹腔镜器械不能形成有效“操作三角”和器械碰撞“打架”问题,设计可以避免和减少器械碰撞并重建“操作三角”的单孔腹腔镜器械。
3.开展单孔腹腔镜(LESS)泌尿外科手术,验证LESS技术在泌尿外科应用的可行性,安全性。
方法：
1.设计供临床和模拟训练使用的单孔腹腔镜多通道开口器,在模拟器训练的基础上,选择可用于临床手术的理想开口器。
2.在对传统腹腔镜器械根据单孔腹腔镜技术特点进行改进,设计符合LESS技术特点的手术器械,重建“操作三角”,减少和避免术中器械“打架”的难题。
3.采用厂家提供和自行设计的单孔腹腔镜开口器、常规腹腔镜器械和自行设计的预弯器械等进行LESS泌尿外科手术,包括：肾囊肿去顶术、精索静脉结扎术和膀胱癌根治性切除术,观察手术时间、出血量、临床疗效和并发症等指标,验证LESS技术在泌尿外科临床应用的可行性。
结果：
1.本课题设计的单孔三通道开口器直径大小合适,操作简单,弹性材质有助于开口器放入切口内并和切口紧密接触,不漏气,能够用于真正的单孔腹腔镜手术,如肾囊肿去顶术、精索静脉结扎术等。
2.针对单孔腹腔镜的操作技术特点对常规腹腔镜器械进行改进,可设计出新的器械：a.工作长度加长；b.近端向外侧弯曲；c.远端向内侧弯曲；d.远端半圆形弯曲；e.手柄部位的活动关节。以上改进点可以有几点同时进行。
3.本课题共完成22例LESS手术,其中14例精索静脉曲张、5例肾囊肿去顶和2例膀胱癌根治性切除术(第1例有膀胱部分切除史)。除1例肾囊肿去顶术需中转为传统腹腔镜手术外,其余21例患者均顺利完成单孔腹腔镜手术。需中转手术的患者肾囊肿位于左肾上极背侧,经脐单孔腹腔镜手术在经过2小时尝试后仍不能良好显露,遂决定中转手术,在左侧肋缘下和髂窝各增加1个5mm工作通道,改行传统3孔腹腔镜手术,最后顺利完成手术。
4.本组22例手术中,最短手术时间为35分钟(LESS左精索静脉结扎术),最长手术时间为330分钟((LESS膀胱癌根治术,不包括构建新膀胱的时间),LESS肾囊肿去顶、精索静脉结扎和膀胱癌根治术平均手术时间分别为109min(60-175min,最小值-最大值,下同)、68.65min (35-125min)和305min(240min-330)。LESS肾囊肿去顶、精索静脉结扎和膀胱癌根治术平均术中出血量分别为38ml (5-100ml)、8.2ml(5-20ml),550ml(500ml和600ml),没有患者发生不能控制的大出血,LESS膀胱癌根治术2例患者分别输血400ml和600ml,其余患者无需输血治疗。LESS肾囊肿去顶、精索静脉结扎和膀胱癌根治术平均术后住院时间平均6.3天(3-9天)、5.3天(2-15天)、和43天(37-49天)。
5.临床疗效：20例LESS精索静脉结扎和肾囊肿去顶术患者自述术后无明显疼痛。2例LESS全膀胱切除患者,术后2天内有疼痛感,但不需要额外使用镇痛药物。LESS肾囊肿去顶和精索静脉结扎患者术后第1天即可自行下地活动,谨慎起见术后第2天待肛门排气后,嘱患者进食。LESS全膀胱患者术后3天恢复肠蠕动,术后6天全流饮食,术后9天半流饮食,术后12天普食。14例LESS精索静脉曲张和5例LESS肾囊肿去顶减压术患者切口隐匿于脐部凹陷中,实现了“无疤手术”,这些患者对手术切口的美容效果全部满意。LESS全膀胱切除,因为后续构建新膀胱的需要,切口选择开在下腹正中,术后遗留5-7cm长手术疤痕。6例肾囊肿患者术后复查囊腔较术前明显缩小,2例术前腰痛患者,术后症状消失。14例精索静脉曲张患者中,术前精液异常4例,术后3个月复查均有不同程度的好转,术前阴囊坠胀5例,术后症状消失。LESS全膀胱术后3月复查,未见局部肿瘤复发和远处转移,血生化结果未见明显异常,白天有尿意,排尿基木可控,夜间需使用1-2块尿垫。尿流动力学提示膀胱容量约280ml,残余尿量10ml,最大尿流率11.1ml／s。IVU检查双肾显影良好,双输尿管未见扩张。
6.并发症：全部22例病例中,有1例患者在LESS左精索静脉结扎术后第2天出现左侧急性附睾炎,经加强抗感染治疗后术后15天痊愈出院,1例患者在LESS膀胱癌根治术后出现切口脂肪液化和精神异常(烦躁、幻视,术后第3天),分别经局部加强换药、消炎和镇静治疗后痊愈。其余20例患者术后恢复顺利,无切口疝、腹腔脏器损伤等并发症的发生。
7.在开展单孔腹腔镜手术的初期,由于对其技术特点不够熟悉加上缺乏专用器械,手术时间稍长。随着经验积累、器械改良、操作熟练度提高手术时间会明显缩短,后期LESS肾囊肿去顶和精索静脉结扎术平均手术时间稳定在60分钟左右。首例LESS全膀胱耗时330分钟,第2例即明显缩短至240分钟。
结论：
1.理想的单孔腹腔镜开口器应满足6点要求：直径小、多通道、安全可靠、操作简单、气密性好和固定牢。本课题自行设计的单孔三通道开口器符合上述要求。
2.针对单孔腹腔镜的操作技术特点对常规腹腔镜器械进行改进,设计出工作长度加长、同时近端向外或远端向内弧形弯曲的器械,这样能够克服单孔腹腔镜手术过程中器械“打架”的难题,重建腹腔镜“操作三角”。
3.本课题共纳入22例患者进行单孔腹腔镜肾囊肿去顶术(6例)、精索静脉结扎(14例)、膀胱癌根治术(2例),取得了成功,证明了单孔腹腔镜技术在泌尿外科的临床应用在技术层面是可行的。短期随访显示临床疗效好,远期疗效尤其是肿瘤控制效果有待长期随访证实。
4.丰富的传统腹腔镜手术经验是开展单孔腹腔镜手术的基础,尤其在开展难度高的手术时。我科自2000年以来致力于泌尿外科腹腔镜技术的应用和推广,2002年8月1日开展腹腔镜全膀胱切除术以来至今已在本院完成全膀胱切除术100余例,其中包括多例有膀胱部分切除或肾输尿管切除史的患者,这成为我们能够成功开展单孔腹腔镜全膀胱切除术的坚实基础和信心来源。
5.使用常规腹腔镜器械能够完成单孔腹腔镜手术,甚至是膀胱癌根治性切除这样高难度的手术。在2例LESS全膀胱手术中,我们使用的器械：无损伤抓钳、剪刀、超声刀、双极钳等均为传统腹腔镜器械,虽然在手术过程中多次遇到器械“打架”的情况以及不得不采用的“镜像操作”,最终仍然可以顺利完成手术。
6.采用预弯或可弯的腹腔镜器械对单孔腹腔镜手术的实施能够提供帮助。在LESS'肾囊肿去顶和精索静脉结扎术中,我们比较了常规腹腔镜器械和预弯及可弯的器械,我们认为预弯和可弯器械可以帮助重建“操作三角”,在一定程度上减少了器械“打架”和“镜像操作”的发生,值得重视的是可弯器械使得操作的力量不能准确的传导至器械尖端,加上器械纤细,不方便进行钝性分离。最终我们选择一手常规腹腔镜器械,另一手预弯或可弯器械的操作模式,弯曲器械负责牵拉和暴露,常规器械负责主要操作如止血和切割,这样既很好的利用了弯曲器械的优点,也发挥了我们更加熟悉的常规操作器械的特长。
7.熟练的持镜助手对进行高难度单孔手术是非常重要的。LESS手术和传统腹腔镜手术的一个很大区别在于所有器械“挤在一起”,不能形成有效的“操作三角”,如何能够在非常狭小的空间里找到合适的位置和角度放置腹腔镜窥镜,能在不影响术者操作的同时尽可能保证良好的手术视野是个很大的问题,因此需要具有丰富的传统腹腔镜手术持镜经验的助手,否则手术过程中将需要花费大量的时间来调整腹腔镜和各个器械的位置和角度。
8.单孔腹腔镜手术尤其是经脐单孔腹腔镜手术(U-LESS)术后手术切口隐匿于脐皱褶内,可以实现“无疤”的美容效果,深受患者欢迎。
9.任何一种新技术的开展均存在一个学习曲线问题,随着开展病例数的增多,经验的积累,手术时间会逐渐缩短,并达到学习曲线的平台期,本课题中三种单孔腹腔镜手术均显示了类似的现象。
10.在合理选择病例的前提下发生手术中转和并发症的几率较低。本组22例患者中仅1例左肾上极囊肿患者中转传统3孔腹腔镜手术,1例精索静脉结扎患者术后出现附睾炎,1例全膀胱切除患者出现切口感染和精神异常,发生并发症的患者术后住院时间较其他患者延长。
11.随着技术的成熟和器械的改进,单孔腹腔镜技术有望逐步推广。目前开展单孔腹腔镜手术的机构主要为国内外大型医疗中心,随着技术的完善、成熟和器械的改良、创新,医生培训的完善,以及模拟训练器及动物实验的推行,LESS技术将会进一步推广,成为被广大患者和医生接受并使用的新技术,最终造福更多患者。
Background
Surgery is an important means of medical therapy. It is a double-edged sword, which can heal the disease while cause trauma to the patient. The pursuit for "non-invasive" and perfect cosmetic results is the instinct drive for development of minimally invasive surgery. It was not until 1987 that Mouret successfully underwent laparoscopic cholecystectomy, which opened a new chapter of minimally invasive surgery. Laparoscopy has many advantages, for instance, small incision, cosmetic result, less tissue injury, less bleeding, faster recovery, clear operative field and precise manipulation compared to open surgery. So laparoscopy was widely accepted by doctors and patients. Laparoscopic techniques have dramatically changed minimally invasive surgical landscape and gained rapid development in urology and other specialties throughout the world. In 1991, Clayman successfully underwent the first laparoscopic nephrectomy, which introduced laparoscopic technique into the field of urology.
In 21st century, as science and technology improve, surgeons continue to carry out exploration and innovation in laparoscopic technology. To further decrease associated surgical morbidity and improve cosmetic outcomes, some scholars have proposed'scar-free'surgery, therefore, natural orifice transluminal endoscopic surgery (NOTES) was developed. NOTES means undergoing intra-abdominal surgery via natural orifice (stomach, vagina, rectum or bladder). Although NOTES seems to be a promising new innovation and animal experiments have achieved some success, there are still some problems couldn't be solved by then, such as, cost-performance ratio between damage to health natural orifice and abdominal wall, how to close natural orifice incision effectively and reliably, principles and processes of short-and long-term rehabilitation for natural orifice injury, abdominal incision infection related to NOTES, difficult to make use of conventional laparoscopic techniques and instruments during NOTES procedure, NOTES flexible endoscope is too long and too much bending that increases difficulty for operation and so on. Thus, NOTES is still at clinical trial stage.
To propose reasonable'scar-free'surgery, scholars turned to the bellybutton. Umbilicus is the only inherent physical scar, to make a small umbilical incision, the scar concealed within the umbilicus postoperatively. Thus, laparoendoscopic single-site surgery (LESS) came into being. In 1992, Pelosi et al reported initial laparoscopic appendectomy via the single umbilical incision, then in 1997 Navarra et al reported the first single umbilical port access laparoscopic cholecystectomy. It was not until 2007 that single-incision laparoscopic was introduced into urological field. Rane et al reported first two cases of single port laparoscopic urologic surgery at world congress of endourology, Cancum, Mexico in 2007. Since then many doctors have represented their experience with simple nephrectomy, radical nephrectomy, pyeloplasty, simple prostatectomy via bladder and live donor nephrectomy using single-port laparoscopic technique. It is widely recognized that LESS has good cosmetic outcomes. As with any new and emerging field there is confusion about the nomenclature and terminology used to describe the procedures and techniques. In July of 2008, a multidisciplinary consortium of experts (the LaparoEndoscopic Single-Site Surgery Consortium for Assessment and Research [LESSCAR]) met then determined'laparoendoscopic single-site surgery'(LESS) was both scientifically accurate and colloquially appropriate name for single-incision laparoscopic surgery.
As the role of LESS continues to expand, some problems emerged, such as, it is difficult to achieve triangulation, one of the fundamental concepts of conventional laparoscopic surgery. Good exposure couldn't be achieved during procedure. Does LESS provide safe and effective outcomes to patient?
Objectives
1. To design and supply multi-lumen single port for LESS clinical practice and simulator training according to LESS technique requirements.
2. To develop and supply specialized instruments for LESS which can help rebuild triangulation and reduce devices collision.
3. To carry out LESS urological surgery and verify the feasibility, safety, clinical effectiveness as well.
Methods
1. To design and supply multi-channel single port for LESS. After simulator training experiment the qualified LESS port was used for further clinical practice.
2. To develop specially designed instruments for LESS by modifying conventional laparoscopic instruments, which can help reestablishment of triangulation and reduction of devices collision.
3. To carry out various LESS urological surgeries, such as, unroofing of renal cyst, varicocelectomy and radical cystectomy, with conventional laparoscopic instruments and single multi-channel ports provided by manufacturers or homemade. Operation time, estimated blood loss, clinical effect and complications were observed to verify feasibility, safety of application of LESS in urological field.
Results
1. The designed three-channel single port trocar is size-fit and easy manipulation. Elastic rubber makes insertion of trocar into abdominal cavity easily and the waist part of trocar fits the incision well which results in good air tightness. The homemade three-channel single port can be used for real laparoendoscopic single-site surgery such as unroofing of renal cyst, varicocelectomy.
2. LESS apparatus can be achieved by improving standard laparoscopic instruments based on the technical characteristics of LESS. There are some innovations can be adopted in design of new LESS instruments:a. working length increased; b. proximal bend laterally; c. distal bend medially; d. distal semi-circular curved; e. joint at handle knot. Two or more points can be improved at the same time.
3. Conversion:There were a total of 22 patients enrolled in the study,14 varicocelectomy,5 unroofing of renal cyst and 2 radical cystectomy. Conversion to conventional laparoscopic surgery required in 1 patient, the remaining 21 cases were successfully completed. The case required surgical conversion is renal cyst located in the left dorsal renal upper pole, after 2 hours dissection good exposure couldn't be achieved, so we decided to add 2 extra trocars, one under the subcostal margin and the other at iliac fossa, then the operation was successfully completed at last.
4. The shortest operation time was 35 minutes (LESS left varicocelectomy), the longest operation time was 330 minutes (LESS radical cystectomy, time for construction of neobladder was excluded). The mean operation time for LESS unroofing of renal cyst, varicocelecomy and radical cystectomy were 109min(range 60-175min),68.6min(range 35-125min) and 305min (range 240-330 min), respectively. The mean estimated blood loss for LESS unroofing of renal cyst, varicocelecomy and radical cystectomy were 38ml (range 5-100ml),8.2ml (range 5-20ml),550ml (range 500ml and 600ml), respectively. No severe bleeding happened.2 LESS radical cystectomy patients needed 400ml and 600ml transfusion, No need of transfusion for the remaining patients. The mean postoperative hospital stay for LESS unroofing of renal cyst, varicocelecomy and radical cystectomy were 6.3 days (range 3-9 days),5.3 days (range 2-15 days) and 43 days (range 37-49 days), respectively.
5. Clinical efficacy:No complain of pain was seen in any unroofing of renal cyst or varicocelectomy case.2 patients of LESS radical cystectomy have pain two days postoperatively, but no need for additional analgesic. Patients with LESS unroofing of renal cyst and varicocelectomy regained self-ambulation 1 day after operation, restored the diet 2 days after operation. The resumption of peristalsis, restoration of the normal diet happened at 3,9 days respectively after operation in patients with LESS radical cystectomy. The incision scar was hidden within umbilicus in 5 patients with LESS unroofing of renal cyst and 14 patients with LESS varicocelectomy. 'Scar-free surgery'was achieved, and those patients were satisfied with incision cosmetic appearance. LESS radical cystectomy left 7-cm long incision scar at lower abdomen. The capacity of renal cyst cavity was significantly reduced postoperatively compared to that preoperative in all 6 patients. The back pain was relieved postoperative in 2 patients. Of 14 cases varicocele patients,4 with abnormal sperm before surgery, the quality of sperm improved 3 months after operation. No local tumor recurrence and distant metastasis were observed 3 months postoperatively in 2 LESS radical cystecomy cases. Short term follow-up showed normal biochemistry, basically continence during daytime while 1-2 pads were needed during night. Urodynamic tests showed reservoir capacity was about 280ml, residual urine volume 10ml, maximum flow rate 11.1ml/s. IVU showed normal renal function without dilation of bilateral ureters.
6. Complication:In all 22 cases, left side acute epididymitis was detected 2 days after LESS varicocelectomy in one patient, after anti-infective intensive therapy the patient was discharged 15 days postoperatively. One patient with LESS radical cystectomy was observed incision fat necrosis and mental abnormality, treated by local dressing, anti-inflammatory and sedation. The remaining 20 patients recovered uneventfully without complications, such as incisional hernia, visceral injury.
7. At the beginning of carrying out single-port surgery, operating time was quite long due to lack of experience and specialized instruments. As the experience and equipment improved, operation proficiency increased significantly with shorter operation time.
Conclusions
1. Ideal single port trocar should meet the 6 requirements:small diameter, multi-channel, safe, reliable, easy manipulation, good air-tightness and fixed firmly. This study designed three-channel single port trocar made of elastic rubber met all requirements.
2. Develop working length increased and proximal laterally curved or distal medially curved instruments by modifying conventional laparoscopic instruments based on technical characteristics of LESS operation. Newly designed apparatus could overcome devices collision problem and rebuild laparoscopic operation triangulation.
3. Based on the study which included 22 patients underwent laparoendoscopic single-site surgery with low morbidity, it is proved that application of LESS in urological clinical is technically feasible. Short-term follow-up showed good clinical efficacy. Long-term follow-up need to be carry out to determine efficiency especially cancer control efficacy of LESS.
4. The rich experience of conventional laparoscopic surgery is the foundation of performing laparoendoscopic single-site surgery, especially in difficult surgery. Since 2000, we have dedicated to the application and promotion of laparoscopic techniques. In August 1,2002 we performed first laparoscopic radical cystectomy, since then more than 100 laparoscopic radical cystectomies have been completed, including some cases with history of partial cystectomy or nephroureterectomy. With rich experience of conventional laparoscopic surgery, we could successfully perform LESS cystectomy all by ourselves.
5. It is feasible to perform LESS operation with conventional laparoscopic instruments, even radical cystectomy. In two cases of LESS radical cystectomy, we used the following traditional laparoscopic apparatus:atraumatic grasping forceps, scissors, harmonic scalpel, and bipolar forceps. Despite the crowding of instruments and'mirror manipulation', we performed surgery successfully.
6. Prebent or flexible instruments could make great help to LESS operation. We compared the conventional laparoscopic instruments and prebent and flexible devices during LESS unroofing of renal cyst and varicocelectomy, we preferred prebent and flexible instruments in LESS procedure, due to easy rebuild of triangulation and reduction of equipments swordfight and mirror manipulation. But force applied to the instrument tip dissipates along the flexible portion of the shaft limiting some maneuvers during blunt dissection. After several attempts, we chose conventional laparoscopic instruments on the dominant hand, prebent instruments on the other. Thus, prebent equipment is in charge of traction and exposure while conventional equipment of the main manipulation, such as cutting and coagulation, in this way, we took advantage of both types of instruments.
7. Skilled assistants are very important during LESS procedure. Differences between LESS surgery and conventional laparoscopic surgery included instruments crowding and difficulty in building'operation triangulation'. How to find a suitable location and angle for placement of endoscope in a crowded space is challenging.
8. The incision scar hidden within the umbilical folds after LESS especially for transumbilical LESS (U-LESS) operations, thus scar-free surgery was achieved with good cosmetic outcomes.
9. Learning curve issues always happen when someone learns a new techniques. As numbers of cases increased and the accumulation of experience, the operation time will gradually reduced. The learning curve will be overcome.
10. The risk of LESS associated complication and conversion rate were quite low in selective patients. In our study of 22 patients, Conversion to conventional laparoscopic surgery required in 1 patient with renal cyst, the remaining 21 cases were successfully completed. Left side acute epididymitis was detected 2 days after LESS varicocelectomy in one patient, with anti-infective intensive therapy the patient was discharged 15 days postoperatively. One patient with LESS radical cystectomy was observed incision fat necrosis and mental abnormality. Postoperative complications prolonged hospital stay.
11. LESS in urology is in its infancy. Further refinements in instrumentation and operative techniques will be required before it can be widely accepted. Before use in the broader population, prospective, randomized studies are required to determine the true benefit and utility of this novel surgical approach compared with current alternatives. Patients might benefit from this new technology.
外科手术是医学治疗的一种重要手段,是一把“双刃剑”,离不开创伤的“制造”和“愈合”,对于手术“无创”和切口“美观”的追求成为外科手术“微创化”发展的动力。1987年法国里昂医生Mouret成功为患者施行腹腔镜下胆囊切除术,揭开了“微创”外科的新篇章。腹腔镜手术以其切口小、美观、组织损伤小、出血少、恢复快、术野清晰、操作精细等优势被医师和患者广泛接受,腹腔镜技术为微创外科领域带来了巨大变革,并在世界范围内得到迅速推广,在泌尿外科以及其它专科中迅速发展,1991年美国医生Clayman完成首例腹腔镜下肾切除,成功将腹腔镜技术引入泌尿外科领域。
进入21世纪以来,随着科学技术的进步,外科医师继续在腹腔镜技术上进行探索和创新。为了进一步减少手术创伤及达到更好的美容效果,有学者提出“无疤手术”的设想。在此背景下经自然腔道内镜手术(NOTES, natural orifice transluminal endoscopic surgery)问世,NOTES是指经自然腔道(胃、阴道、直肠或膀胱)置入软镜,通过管壁切口进入腹腔开展手术。虽然NOTES以乎是一种很有前途的新技术,动物实验也取得了一定的成功,但NOTES尚存在一些目前未能完全解决的问题,如：健康自然腔道损伤与腹壁软组织损伤的代价比；如何有效可靠的关闭自然腔道切口；自然腔道损伤的近、远期修复原理和过程；自然腔道手术可能导致腹腔污染；难以利用现有腹腔镜技术和器械；NOTES软性内镜过长及过多弯曲、操作困难等,因此NOTES技术目前仍处于临床探索阶段。
为了寻求可行的“无疤”手术,学者将目标转向了肚脐。脐是身体上唯一与生俱来的瘢痕,在脐部做一小切口,术后的瘢痕可隐藏于肚脐皱褶内,从而实现手术“无疤痕”化,在这种情况下单孔腹腔镜技术应运而生。Pelosi等于1992年报导首例经脐单孔腹腔镜下阑尾切除术,Navarra等于1997年报导了经脐单孔腹腔镜胆囊切除术。单孔腹腔镜在泌尿外科的应用始于2007年,Rane等在2007年报告了最早2例单孔腹腔镜泌尿外科手术,此后有学者陆续报道了经脐单孔腹腔镜肾切除术、根治性肾切除术、肾盂成形术、经膀胱单孔单纯前列腺切除术和活体供肾切取术等单孔腹腔镜手术。LESS术后的美容效果得到了广泛认可。在单孔腹腔镜手术开展的同时,各种命名方法层出不穷,为了使单孔腹腔镜手术更为规范,2008年7月成立了腹腔镜内窥镜单孔手术评估和研究组(LESSCAR),与会专家确定了单孔腹腔镜的统一命名——laparoendoscopic single-site surgery (LESS)。
随着单孔腹腔镜技术的开展,一些问题浮出水面：1.有悖传统腹腔镜手术的基本要求——“操作三角”,使得医生的操作不符合人体工学设计原理,极易疲劳；2.采用传统器械时,由于所有器械经过单一切口进行操作,“筷子效应”导致各器械之间互相碰撞和“打架”的现象时常发生；3.暴露不好,由于可同时使用的操作器械有限,对手术部位的暴露很困难；4.一些学者质疑单孔腹腔镜手术的安全性和有效性。
本课题拟针对上述问题进行研究,设计合理的单孔腹腔镜开口器、预弯器械,开展LESS泌尿外科手术,验证LESS手术的可行性、安全性和临床疗效。
目的：
1.根据单孔腹腔镜技术要求,设计能够供给临床实践和模拟训练使用的单孔腹腔镜开口器。
2.解决单孔腹腔镜手术过程中常见的使用传统腹腔镜器械不能形成有效“操作三角”和器械碰撞“打架”问题,设计可以避免和减少器械碰撞并重建“操作三角”的单孔腹腔镜器械。
3.开展单孔腹腔镜(LESS)泌尿外科手术,验证LESS技术在泌尿外科应用的可行性,安全性。
方法：
1.设计供临床和模拟训练使用的单孔腹腔镜多通道开口器,在模拟器训练的基础上,选择可用于临床手术的理想开口器。
2.在对传统腹腔镜器械根据单孔腹腔镜技术特点进行改进,设计符合LESS技术特点的手术器械,重建“操作三角”,减少和避免术中器械“打架”的难题。
3.采用厂家提供和自行设计的单孔腹腔镜开口器、常规腹腔镜器械和自行设计的预弯器械等进行LESS泌尿外科手术,包括：肾囊肿去顶术、精索静脉结扎术和膀胱癌根治性切除术,观察手术时间、出血量、临床疗效和并发症等指标,验证LESS技术在泌尿外科临床应用的可行性。
结果：
1.本课题设计的单孔三通道开口器直径大小合适,操作简单,弹性材质有助于开口器放入切口内并和切口紧密接触,不漏气,能够用于真正的单孔腹腔镜手术,如肾囊肿去顶术、精索静脉结扎术等。
2.针对单孔腹腔镜的操作技术特点对常规腹腔镜器械进行改进,可设计出新的器械：a.工作长度加长；b.近端向外侧弯曲；c.远端向内侧弯曲；d.远端半圆形弯曲；e.手柄部位的活动关节。以上改进点可以有几点同时进行。
3.本课题共完成22例LESS手术,其中14例精索静脉曲张、5例肾囊肿去顶和2例膀胱癌根治性切除术(第1例有膀胱部分切除史)。除1例肾囊肿去顶术需中转为传统腹腔镜手术外,其余21例患者均顺利完成单孔腹腔镜手术。需中转手术的患者肾囊肿位于左肾上极背侧,经脐单孔腹腔镜手术在经过2小时尝试后仍不能良好显露,遂决定中转手术,在左侧肋缘下和髂窝各增加1个5mm工作通道,改行传统3孔腹腔镜手术,最后顺利完成手术。
4.本组22例手术中,最短手术时间为35分钟(LESS左精索静脉结扎术),最长手术时间为330分钟((LESS膀胱癌根治术,不包括构建新膀胱的时间),LESS肾囊肿去顶、精索静脉结扎和膀胱癌根治术平均手术时间分别为109min(60-175min,最小值-最大值,下同)、68.65min (35-125min)和305min(240min-330)。LESS肾囊肿去顶、精索静脉结扎和膀胱癌根治术平均术中出血量分别为38ml (5-100ml)、8.2ml(5-20ml),550ml(500ml和600ml),没有患者发生不能控制的大出血,LESS膀胱癌根治术2例患者分别输血400ml和600ml,其余患者无需输血治疗。LESS肾囊肿去顶、精索静脉结扎和膀胱癌根治术平均术后住院时间平均6.3天(3-9天)、5.3天(2-15天)、和43天(37-49天)。
5.临床疗效：20例LESS精索静脉结扎和肾囊肿去顶术患者自述术后无明显疼痛。2例LESS全膀胱切除患者,术后2天内有疼痛感,但不需要额外使用镇痛药物。LESS肾囊肿去顶和精索静脉结扎患者术后第1天即可自行下地活动,谨慎起见术后第2天待肛门排气后,嘱患者进食。LESS全膀胱患者术后3天恢复肠蠕动,术后6天全流饮食,术后9天半流饮食,术后12天普食。14例LESS精索静脉曲张和5例LESS肾囊肿去顶减压术患者切口隐匿于脐部凹陷中,实现了“无疤手术”,这些患者对手术切口的美容效果全部满意。LESS全膀胱切除,因为后续构建新膀胱的需要,切口选择开在下腹正中,术后遗留5-7cm长手术疤痕。6例肾囊肿患者术后复查囊腔较术前明显缩小,2例术前腰痛患者,术后症状消失。14例精索静脉曲张患者中,术前精液异常4例,术后3个月复查均有不同程度的好转,术前阴囊坠胀5例,术后症状消失。LESS全膀胱术后3月复查,未见局部肿瘤复发和远处转移,血生化结果未见明显异常,白天有尿意,排尿基木可控,夜间需使用1-2块尿垫。尿流动力学提示膀胱容量约280ml,残余尿量10ml,最大尿流率11.1ml／s。IVU检查双肾显影良好,双输尿管未见扩张。
6.并发症：全部22例病例中,有1例患者在LESS左精索静脉结扎术后第2天出现左侧急性附睾炎,经加强抗感染治疗后术后15天痊愈出院,1例患者在LESS膀胱癌根治术后出现切口脂肪液化和精神异常(烦躁、幻视,术后第3天),分别经局部加强换药、消炎和镇静治疗后痊愈。其余20例患者术后恢复顺利,无切口疝、腹腔脏器损伤等并发症的发生。
7.在开展单孔腹腔镜手术的初期,由于对其技术特点不够熟悉加上缺乏专用器械,手术时间稍长。随着经验积累、器械改良、操作熟练度提高手术时间会明显缩短,后期LESS肾囊肿去顶和精索静脉结扎术平均手术时间稳定在60分钟左右。首例LESS全膀胱耗时330分钟,第2例即明显缩短至240分钟。
结论：
1.理想的单孔腹腔镜开口器应满足6点要求：直径小、多通道、安全可靠、操作简单、气密性好和固定牢。本课题自行设计的单孔三通道开口器符合上述要求。
2.针对单孔腹腔镜的操作技术特点对常规腹腔镜器械进行改进,设计出工作长度加长、同时近端向外或远端向内弧形弯曲的器械,这样能够克服单孔腹腔镜手术过程中器械“打架”的难题,重建腹腔镜“操作三角”。
3.本课题共纳入22例患者进行单孔腹腔镜肾囊肿去顶术(6例)、精索静脉结扎(14例)、膀胱癌根治术(2例),取得了成功,证明了单孔腹腔镜技术在泌尿外科的临床应用在技术层面是可行的。短期随访显示临床疗效好,远期疗效尤其是肿瘤控制效果有待长期随访证实。
4.丰富的传统腹腔镜手术经验是开展单孔腹腔镜手术的基础,尤其在开展难度高的手术时。我科自2000年以来致力于泌尿外科腹腔镜技术的应用和推广,2002年8月1日开展腹腔镜全膀胱切除术以来至今已在本院完成全膀胱切除术100余例,其中包括多例有膀胱部分切除或肾输尿管切除史的患者,这成为我们能够成功开展单孔腹腔镜全膀胱切除术的坚实基础和信心来源。
5.使用常规腹腔镜器械能够完成单孔腹腔镜手术,甚至是膀胱癌根治性切除这样高难度的手术。在2例LESS全膀胱手术中,我们使用的器械：无损伤抓钳、剪刀、超声刀、双极钳等均为传统腹腔镜器械,虽然在手术过程中多次遇到器械“打架”的情况以及不得不采用的“镜像操作”,最终仍然可以顺利完成手术。
6.采用预弯或可弯的腹腔镜器械对单孔腹腔镜手术的实施能够提供帮助。在LESS'肾囊肿去顶和精索静脉结扎术中,我们比较了常规腹腔镜器械和预弯及可弯的器械,我们认为预弯和可弯器械可以帮助重建“操作三角”,在一定程度上减少了器械“打架”和“镜像操作”的发生,值得重视的是可弯器械使得操作的力量不能准确的传导至器械尖端,加上器械纤细,不方便进行钝性分离。最终我们选择一手常规腹腔镜器械,另一手预弯或可弯器械的操作模式,弯曲器械负责牵拉和暴露,常规器械负责主要操作如止血和切割,这样既很好的利用了弯曲器械的优点,也发挥了我们更加熟悉的常规操作器械的特长。
7.熟练的持镜助手对进行高难度单孔手术是非常重要的。LESS手术和传统腹腔镜手术的一个很大区别在于所有器械“挤在一起”,不能形成有效的“操作三角”,如何能够在非常狭小的空间里找到合适的位置和角度放置腹腔镜窥镜,能在不影响术者操作的同时尽可能保证良好的手术视野是个很大的问题,因此需要具有丰富的传统腹腔镜手术持镜经验的助手,否则手术过程中将需要花费大量的时间来调整腹腔镜和各个器械的位置和角度。
8.单孔腹腔镜手术尤其是经脐单孔腹腔镜手术(U-LESS)术后手术切口隐匿于脐皱褶内,可以实现“无疤”的美容效果,深受患者欢迎。
9.任何一种新技术的开展均存在一个学习曲线问题,随着开展病例数的增多,经验的积累,手术时间会逐渐缩短,并达到学习曲线的平台期,本课题中三种单孔腹腔镜手术均显示了类似的现象。
10.在合理选择病例的前提下发生手术中转和并发症的几率较低。本组22例患者中仅1例左肾上极囊肿患者中转传统3孔腹腔镜手术,1例精索静脉结扎患者术后出现附睾炎,1例全膀胱切除患者出现切口感染和精神异常,发生并发症的患者术后住院时间较其他患者延长。
11.随着技术的成熟和器械的改进,单孔腹腔镜技术有望逐步推广。目前开展单孔腹腔镜手术的机构主要为国内外大型医疗中心,随着技术的完善、成熟和器械的改良、创新,医生培训的完善,以及模拟训练器及动物实验的推行,LESS技术将会进一步推广,成为被广大患者和医生接受并使用的新技术,最终造福更多患者。
Background
Surgery is an important means of medical therapy. It is a double-edged sword, which can heal the disease while cause trauma to the patient. The pursuit for "non-invasive" and perfect cosmetic results is the instinct drive for development of minimally invasive surgery. It was not until 1987 that Mouret successfully underwent laparoscopic cholecystectomy, which opened a new chapter of minimally invasive surgery. Laparoscopy has many advantages, for instance, small incision, cosmetic result, less tissue injury, less bleeding, faster recovery, clear operative field and precise manipulation compared to open surgery. So laparoscopy was widely accepted by doctors and patients. Laparoscopic techniques have dramatically changed minimally invasive surgical landscape and gained rapid development in urology and other specialties throughout the world. In 1991, Clayman successfully underwent the first laparoscopic nephrectomy, which introduced laparoscopic technique into the field of urology.
In 21st century, as science and technology improve, surgeons continue to carry out exploration and innovation in laparoscopic technology. To further decrease associated surgical morbidity and improve cosmetic outcomes, some scholars have proposed'scar-free'surgery, therefore, natural orifice transluminal endoscopic surgery (NOTES) was developed. NOTES means undergoing intra-abdominal surgery via natural orifice (stomach, vagina, rectum or bladder). Although NOTES seems to be a promising new innovation and animal experiments have achieved some success, there are still some problems couldn't be solved by then, such as, cost-performance ratio between damage to health natural orifice and abdominal wall, how to close natural orifice incision effectively and reliably, principles and processes of short-and long-term rehabilitation for natural orifice injury, abdominal incision infection related to NOTES, difficult to make use of conventional laparoscopic techniques and instruments during NOTES procedure, NOTES flexible endoscope is too long and too much bending that increases difficulty for operation and so on. Thus, NOTES is still at clinical trial stage.
To propose reasonable'scar-free'surgery, scholars turned to the bellybutton. Umbilicus is the only inherent physical scar, to make a small umbilical incision, the scar concealed within the umbilicus postoperatively. Thus, laparoendoscopic single-site surgery (LESS) came into being. In 1992, Pelosi et al reported initial laparoscopic appendectomy via the single umbilical incision, then in 1997 Navarra et al reported the first single umbilical port access laparoscopic cholecystectomy. It was not until 2007 that single-incision laparoscopic was introduced into urological field. Rane et al reported first two cases of single port laparoscopic urologic surgery at world congress of endourology, Cancum, Mexico in 2007. Since then many doctors have represented their experience with simple nephrectomy, radical nephrectomy, pyeloplasty, simple prostatectomy via bladder and live donor nephrectomy using single-port laparoscopic technique. It is widely recognized that LESS has good cosmetic outcomes. As with any new and emerging field there is confusion about the nomenclature and terminology used to describe the procedures and techniques. In July of 2008, a multidisciplinary consortium of experts (the LaparoEndoscopic Single-Site Surgery Consortium for Assessment and Research [LESSCAR]) met then determined'laparoendoscopic single-site surgery'(LESS) was both scientifically accurate and colloquially appropriate name for single-incision laparoscopic surgery.
As the role of LESS continues to expand, some problems emerged, such as, it is difficult to achieve triangulation, one of the fundamental concepts of conventional laparoscopic surgery. Good exposure couldn't be achieved during procedure. Does LESS provide safe and effective outcomes to patient?
Objectives
1. To design and supply multi-lumen single port for LESS clinical practice and simulator training according to LESS technique requirements.
2. To develop and supply specialized instruments for LESS which can help rebuild triangulation and reduce devices collision.
3. To carry out LESS urological surgery and verify the feasibility, safety, clinical effectiveness as well.
Methods
1. To design and supply multi-channel single port for LESS. After simulator training experiment the qualified LESS port was used for further clinical practice.
2. To develop specially designed instruments for LESS by modifying conventional laparoscopic instruments, which can help reestablishment of triangulation and reduction of devices collision.
3. To carry out various LESS urological surgeries, such as, unroofing of renal cyst, varicocelectomy and radical cystectomy, with conventional laparoscopic instruments and single multi-channel ports provided by manufacturers or homemade. Operation time, estimated blood loss, clinical effect and complications were observed to verify feasibility, safety of application of LESS in urological field.
Results
1. The designed three-channel single port trocar is size-fit and easy manipulation. Elastic rubber makes insertion of trocar into abdominal cavity easily and the waist part of trocar fits the incision well which results in good air tightness. The homemade three-channel single port can be used for real laparoendoscopic single-site surgery such as unroofing of renal cyst, varicocelectomy.
2. LESS apparatus can be achieved by improving standard laparoscopic instruments based on the technical characteristics of LESS. There are some innovations can be adopted in design of new LESS instruments:a. working length increased; b. proximal bend laterally; c. distal bend medially; d. distal semi-circular curved; e. joint at handle knot. Two or more points can be improved at the same time.
3. Conversion:There were a total of 22 patients enrolled in the study,14 varicocelectomy,5 unroofing of renal cyst and 2 radical cystectomy. Conversion to conventional laparoscopic surgery required in 1 patient, the remaining 21 cases were successfully completed. The case required surgical conversion is renal cyst located in the left dorsal renal upper pole, after 2 hours dissection good exposure couldn't be achieved, so we decided to add 2 extra trocars, one under the subcostal margin and the other at iliac fossa, then the operation was successfully completed at last.
4. The shortest operation time was 35 minutes (LESS left varicocelectomy), the longest operation time was 330 minutes (LESS radical cystectomy, time for construction of neobladder was excluded). The mean operation time for LESS unroofing of renal cyst, varicocelecomy and radical cystectomy were 109min(range 60-175min),68.6min(range 35-125min) and 305min (range 240-330 min), respectively. The mean estimated blood loss for LESS unroofing of renal cyst, varicocelecomy and radical cystectomy were 38ml (range 5-100ml),8.2ml (range 5-20ml),550ml (range 500ml and 600ml), respectively. No severe bleeding happened.2 LESS radical cystectomy patients needed 400ml and 600ml transfusion, No need of transfusion for the remaining patients. The mean postoperative hospital stay for LESS unroofing of renal cyst, varicocelecomy and radical cystectomy were 6.3 days (range 3-9 days),5.3 days (range 2-15 days) and 43 days (range 37-49 days), respectively.
5. Clinical efficacy:No complain of pain was seen in any unroofing of renal cyst or varicocelectomy case.2 patients of LESS radical cystectomy have pain two days postoperatively, but no need for additional analgesic. Patients with LESS unroofing of renal cyst and varicocelectomy regained self-ambulation 1 day after operation, restored the diet 2 days after operation. The resumption of peristalsis, restoration of the normal diet happened at 3,9 days respectively after operation in patients with LESS radical cystectomy. The incision scar was hidden within umbilicus in 5 patients with LESS unroofing of renal cyst and 14 patients with LESS varicocelectomy. 'Scar-free surgery'was achieved, and those patients were satisfied with incision cosmetic appearance. LESS radical cystectomy left 7-cm long incision scar at lower abdomen. The capacity of renal cyst cavity was significantly reduced postoperatively compared to that preoperative in all 6 patients. The back pain was relieved postoperative in 2 patients. Of 14 cases varicocele patients,4 with abnormal sperm before surgery, the quality of sperm improved 3 months after operation. No local tumor recurrence and distant metastasis were observed 3 months postoperatively in 2 LESS radical cystecomy cases. Short term follow-up showed normal biochemistry, basically continence during daytime while 1-2 pads were needed during night. Urodynamic tests showed reservoir capacity was about 280ml, residual urine volume 10ml, maximum flow rate 11.1ml/s. IVU showed normal renal function without dilation of bilateral ureters.
6. Complication:In all 22 cases, left side acute epididymitis was detected 2 days after LESS varicocelectomy in one patient, after anti-infective intensive therapy the patient was discharged 15 days postoperatively. One patient with LESS radical cystectomy was observed incision fat necrosis and mental abnormality, treated by local dressing, anti-inflammatory and sedation. The remaining 20 patients recovered uneventfully without complications, such as incisional hernia, visceral injury.
7. At the beginning of carrying out single-port surgery, operating time was quite long due to lack of experience and specialized instruments. As the experience and equipment improved, operation proficiency increased significantly with shorter operation time.
Conclusions
1. Ideal single port trocar should meet the 6 requirements:small diameter, multi-channel, safe, reliable, easy manipulation, good air-tightness and fixed firmly. This study designed three-channel single port trocar made of elastic rubber met all requirements.
2. Develop working length increased and proximal laterally curved or distal medially curved instruments by modifying conventional laparoscopic instruments based on technical characteristics of LESS operation. Newly designed apparatus could overcome devices collision problem and rebuild laparoscopic operation triangulation.
3. Based on the study which included 22 patients underwent laparoendoscopic single-site surgery with low morbidity, it is proved that application of LESS in urological clinical is technically feasible. Short-term follow-up showed good clinical efficacy. Long-term follow-up need to be carry out to determine efficiency especially cancer control efficacy of LESS.
4. The rich experience of conventional laparoscopic surgery is the foundation of performing laparoendoscopic single-site surgery, especially in difficult surgery. Since 2000, we have dedicated to the application and promotion of laparoscopic techniques. In August 1,2002 we performed first laparoscopic radical cystectomy, since then more than 100 laparoscopic radical cystectomies have been completed, including some cases with history of partial cystectomy or nephroureterectomy. With rich experience of conventional laparoscopic surgery, we could successfully perform LESS cystectomy all by ourselves.
5. It is feasible to perform LESS operation with conventional laparoscopic instruments, even radical cystectomy. In two cases of LESS radical cystectomy, we used the following traditional laparoscopic apparatus:atraumatic grasping forceps, scissors, harmonic scalpel, and bipolar forceps. Despite the crowding of instruments and'mirror manipulation', we performed surgery successfully.
6. Prebent or flexible instruments could make great help to LESS operation. We compared the conventional laparoscopic instruments and prebent and flexible devices during LESS unroofing of renal cyst and varicocelectomy, we preferred prebent and flexible instruments in LESS procedure, due to easy rebuild of triangulation and reduction of equipments swordfight and mirror manipulation. But force applied to the instrument tip dissipates along the flexible portion of the shaft limiting some maneuvers during blunt dissection. After several attempts, we chose conventional laparoscopic instruments on the dominant hand, prebent instruments on the other. Thus, prebent equipment is in charge of traction and exposure while conventional equipment of the main manipulation, such as cutting and coagulation, in this way, we took advantage of both types of instruments.
7. Skilled assistants are very important during LESS procedure. Differences between LESS surgery and conventional laparoscopic surgery included instruments crowding and difficulty in building'operation triangulation'. How to find a suitable location and angle for placement of endoscope in a crowded space is challenging.
8. The incision scar hidden within the umbilical folds after LESS especially for transumbilical LESS (U-LESS) operations, thus scar-free surgery was achieved with good cosmetic outcomes.
9. Learning curve issues always happen when someone learns a new techniques. As numbers of cases increased and the accumulation of experience, the operation time will gradually reduced. The learning curve will be overcome.
10. The risk of LESS associated complication and conversion rate were quite low in selective patients. In our study of 22 patients, Conversion to conventional laparoscopic surgery required in 1 patient with renal cyst, the remaining 21 cases were successfully completed. Left side acute epididymitis was detected 2 days after LESS varicocelectomy in one patient, with anti-infective intensive therapy the patient was discharged 15 days postoperatively. One patient with LESS radical cystectomy was observed incision fat necrosis and mental abnormality. Postoperative complications prolonged hospital stay.
11. LESS in urology is in its infancy. Further refinements in instrumentation and operative techniques will be required before it can be widely accepted. Before use in the broader population, prospective, randomized studies are required to determine the true benefit and utility of this novel surgical approach compared with current alternatives. Patients might benefit from this new technology.
引文
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