前列腺癌根治术125例临床研究
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摘要
研究背景
前列腺癌是泌尿生殖系统最常见的恶性肿瘤之一,好发于老年男性,严重威胁生命健康。对于早期局限性前列腺癌,即术前评估肿瘤分期在cT2期以内、无转移灶的患者,前列腺癌根治术的肿瘤治疗效果确切,患者术后可望获得长期生存,且近远期并发症的发生率多在可接受的范围,被认为是首选的治疗方案[1]；对于局部进展期前列腺癌,即cT3期患者,由于术后切缘阳性的可能性明显增加,且可能存在难以评估的淋巴结转移或远处转移,既往并不被推荐行根治性手术治疗,但近年来有限的文献(包括一些前瞻性研究)报道,患者行前列腺癌根治术仍有可能获益,尽管这一观点在不同的研究者和研究中心具有较大的争议,但仍表明了根治性手术治疗在针对局部进展期前列腺癌患者的治疗中具有一定的地位[2]；而对于cT4期及伴有淋巴结转移或远处转移的任何分期的患者,大多数学者认为不予行前列腺癌根治术而转为内分泌治疗和(或)放射治疗,因为手术仅能为肿瘤的分期提供依据而对肿瘤的治疗并无益处。但目前国外有大规模研究表明,即使对于伴有淋巴结转移的前列腺癌患者,行前列腺癌根治术仍可提高其肿瘤特异性生存率,研究者认为根治性手术对于前列腺癌淋巴结转移患者仍然可获益。
在手术过程中,阴茎背血管复合体(Dorsal Vascular Complex, DVC)的合理处理是控制出血的关键之一。国内外大多数学者认为,缝扎DVC可以有效的控制出血。另有研究认为,DVC的处理方式对术后尿控的恢复速度有一定的影响。选择性缝扎,即在切断DVC后根据必要性进行缝扎,要比常规的先缝扎后切断能获得更高的术后早期尿控率。最近的一项回顾性研究认为,随着手术器械的发展,免缝扎DVC技术也是可行的,其并不增加术中及术后出血和输血的风险[6。
随着医疗技术的发展,前列腺癌根治术是一项已趋成熟的手术方式,且治疗效果令人满意。但是,仍存在一些值得关注或争议较大的问题,例如：对于pT3期及以上,或已有淋巴结转移的前列腺癌患者的根治性手术的意义,国内外研究数据极其有限,且各研究者的结论有较大的争议,尚待更多的研究中心提供数据予以充实,亦可为将来多中心的荟萃分析提供文献支持；作为一项应用较少的技术,免缝扎DVC技术的安全性、可行性以及是否具有优越性仍亟待研究；关于前列腺两侧血管神经束(Neurovascular Bundle, NVB)的保留对尿控的影响,术前血清初始前列腺特异性抗原(Prostate Specific Antigen, PSA)水平与术后Gleason评分及病理分期的相关性问题,以及生化复发的独立预测因素等问题,均亟待研究探讨或充实。
研究目的
对纳入研究的所有患者的术前临床资料、围手术期临床资料、术中与术后并发症、无生化复发生存时间、失访与死亡时间、结局等临床资料进行统计学描述与分析,初步探讨免缝扎DVC技术的安全性、可行性及优越性与否；阐明前列腺两侧NVB的保留对尿控的影响；探讨术前PSA对于预测术后Gleason评分及病理分期的意义；基于以上资料,应用Kaplan-Meier法进行生存分析,分别阐明不同因素对无生化复发生存时间的影响；进一步行Cox多因素回归分析,探讨生化复发的独立危险因素。通过以上一系列研究,期待为更合理确定手术适应症、改进手术方式、提高肿瘤治疗效果及患者术后生存质量提供统计学依据,并为国际上尚存争议的一些问题提供单中心研究数据。
研究方法
本研究属于回顾性临床研究。统计南方医科大学附属珠江医院泌尿外科自2002年2月至2013年2月,接受前列腺癌根治术、术前及术后病理均证实为前列腺癌,且获得规律随访时间超过3个月、临床资料完整的125例患者的随访资料。
1围手术期资料收集通过南方医科大学附属珠江医院医生工作站、嘉禾电子病历系统及病案室查询纸质病历三种方式复习病案,收集患者的围手术期临床资料,包括：①术前资料：患者基本信息、首发症状、国际前列腺症状评分、体重指数、美国麻醉师协会麻醉分级、伴发基础疾病情况、术前初始PSA、fPSA/PSA(%).肿瘤临床分期、肿瘤Gleason评分(包括主要评分与次要评分)、治疗史、控尿情况、阴茎勃起功能(仅针对年龄≤70岁,术前阴茎勃起功能满意,有性生活需求的患者)；②术中：手术日期、手术方式、手术时长、出血量、输血量、盆腔淋巴结清扫情况、双侧NVB处理方式、DVC处理方式、切缘情况、术中并发症(包括术中严重出血、心肺功能衰竭、直肠损伤、膀胱损伤、输尿管损伤、闭孔神经损伤等)；③术后：包括术后Gleason评分(包括主要评分与次要评分)、术后病理分期、留置尿管天数、围手术期并发症(指患者手术后至出院前所出现的并发症,亦属于术后早期并发症范畴,包括：术后严重出血、肺部感染、心肺功能衰竭、尿瘘、肠瘘、膀胱尿道吻合口狭窄、尿道狭窄、尿失禁、深静脉血栓、肺栓塞、切口脂肪液化或感染等原因造成的愈合不良、淋巴囊肿等)、术后治疗情况。
2术后随访资料收集方法建立患者的手术时间与术后随访计划表。患者出院时,嘱其在术后2年内每3个月返院复查1次,2年后每6个月返院复查1次,5年后每1年返院复查1次。对于因各种原因没有按时返院复查的患者,及时通过电话或邮件的方式通知对方返院复查；对于确实无法或无意愿返院复查的患者,嘱其在当地医院就近复查相关项目后,将检查及检验报告以电话、短信、照片、信件或电子邮件等方式予以及时反馈,并通过有效的沟通以确保随访资料的完整性与可靠性,作好详实的登记；对于联系电话、通讯地址等信息变更后未能联系上的患者,以及极其不愿配合随访而失去联系的患者,按失随访处理。
3术后随访指标包括：①随访日期；②术后早期(术后3个月内)资料,包括：血清PSA水平、fPSA/tPSA、最大尿流率、平均尿流率、胸部平片、腹部平片、腹部B超(包括肝胆胰脾及泌尿系统)、盆腔MRI、全身骨显像、肿瘤复发与转移情况、生化复发情况、术后并发症(包括：术后严重出血、肺部感染、心肺功能衰竭、尿瘘、膀胱尿道吻合口狭窄、尿道狭窄、尿失禁、深静脉血栓、肺栓塞、切口脂肪液化或感染等原因造成的愈合不良、淋巴囊肿、死亡等)、术后全天需要使用的尿垫数量、术后治疗情况、失随访与死亡情况(注明原因)；③术后远期(术后3个月后)资料,包括：血清PSA水平、fPSA/tPSA、最大尿流率、平均尿流率、胸部平片、腹部平片、腹部B超(包括肝胆胰脾及泌尿系统)、盆腔MRI、全身骨显像、肿瘤复发与转移情况、生化复发情况、术后并发症(包括：膀胱尿道吻合口狭窄、尿道狭窄、尿失禁、阴茎勃起功能障碍等)、术后全天需要使用的尿垫数量、术后治疗情况、失随访与死亡情况(注明原因)。其中,阴茎勃起功能的评估与术前对应,即仅针对年龄≤70岁,术前阴茎勃起功能满意,有性生活需求的患者。
4统计学分析方法所有的资料均采用SPSS18.0统计软件处理,检验水准α=0.05。描述性统计结果以频数(f)或均数±标准差(X±S)表示；两独立组间率的比较采用χ2检验或Fisher精确概率检验；多个独立组间率的比较采用χ2检验,两均数的比较采用两独立样本t检验；两有序等级资料之间的相关性研究采用Spearman等级相关法；分组变量无序,评价指标变量有序,评价不同组别某指标之间是否有差别采用Kruskal-Wallis H检验,并进一步使用VVilcoxon秩和检验比较两组间差异,采用Bonferroni法对检验水准进行校正,α=0.05/比较次数。应用Kaplan-Meier法绘制无生化复发生存曲线,采用Log-rank检验分别比较单因素不同水平的生存曲线差异性。多因素分析使用Cox比例风险模型,以筛选生化复发的预测因素。
研究结果
1免缝扎DVC技术临床效果的初步探讨免缝扎DVC组37例(29.6%),缝扎DVC组88例(70.4%),平均手术时间199.5分钟vs213.6分钟(t=-1.180,P=0.240),平均出血量209.5ml vs205.0ml(t=0.111,P=0.912),平均输血量148.7ml vs130.7ml(t=0.408,P=0.685),输血率32.4%vs43.2%(χ2=1.254,P=0.263)。
2NVB的处理方式与尿控术中未保留NVB58例(46.4%),保留单侧NVB27例(21.6%),保留双侧NVB40例(32.0%)。未保留NVB、保留单侧NVB、保留双侧NVB三种处理方式术后3个月时的控尿率分别为：70.7%、81.5%、97.5%,不完全一致(χ2=11.334,P=0.003)；对于术后3个月时的全天尿垫数量,Kruskal-Wallis H检验与Wilcoxon秩和检验示：三种不同的NVB处理方式,术后早期全天尿垫数量是不全相同的(χ2=25.686,P=0.000),平均秩次依次为：77.19、61.83、43.21；根据平均秩次进一步推测：不保留NVB者术后早期全天需要使用的尿垫数量最多,保留单侧NVB者次之,而保留双侧NVB者使用的尿垫数量最少。但不保留NVB与保留单侧NVB的差别无统计学意义(P=0.046>0.025),而与保留双侧NVB的差别具有统计学意义(P=0.000<0.025),后者使用的尿垫数量较少；保留单侧NVB与保留双侧NVB的差别具有统计学意义(P=0.006<0.025),后者使用的尿垫数量较少。Sperman等级相关检验示,血管神经束保留程度与术后早期全天使用尿垫数量呈显著的负相关关系(rs=-0.453,P=0.000)。
3术前PSA与术后Gleason评分及病理分期的关系术前PSA水平：<4.0ng/ml者8例(6.4%),4.0～10.0ng/ml者38例(30.4%),10.0～20.0ng/ml者34例(27.2%),>20ng/ml者45例(36.0%)；术后Gleason评分：2-6分67例(53.6%),7分27例(21.6%),8分19例(15.2%),9-10分12例(9.6%)；术后病理分期：pTl期14例(11.2%),pT2期75例(60.0%),pT3期34例(27.2%),pT4期2例(1.6%)。Sperman等级相关检验示：术前PSA与术后Gleason评分呈显著的正相关关系(rs=0.345,P=0.000)；术前PSA与术后病理分期的呈显著的正相关关系(rs=0.284,P=0.001)；术后Gleason评分与术后病理分期呈显著的正相关关系(rs=0.642,P=0.000)。
4术后早期并发症与远期转归共发生手术相关性早期并发症10种,49人共发生并发症57例次。其中：尿失禁23例(拔除尿管3个月时评估)、尿路感染11例、切口愈合不良7例、尿瘘5例、尿道狭窄3例、吻合口狭窄3例、肠瘘2例、附睾炎1例、肺部感染1例、阴茎伴下肢淋巴水肿1例。其中,7人发生2种及2种以上的并发症：尿瘘合并尿失禁3例,尿路感染合并附睾炎1例,尿失禁合并切口愈合不良1例,尿道狭窄伴吻合口狭窄1例,尿失禁合并尿路感染及阴茎及下肢淋巴水肿1例。术后3个月时,控尿率为81.6%；术后1年时,控尿率为96.1%；术后5年时,控尿率为100%。对于年龄≤70岁,术前阴茎勃起功能满意,有性生活的63例患者,术前按勃起功能国际问卷-5评估勃起功能：21人勃起功能正常,其余42人有轻度的勃起功能障碍；随访至今,有25人(39.7%)恢复了自我满意的阴茎勃起功能,其中：25例未保留NVB的患者中有2例(8.0%),12例保留了单侧NVB的患者中有6例(50.0%),26例保留了双侧NVB的患者中有17例(65.4%)。远期转归或结局：前列腺癌骨转移12例,膀胱尿道吻合口狭窄10例,腹股沟斜疝5例,尿道狭窄5例,膀胱结石3例,原发性肺癌3例,尿路感染1例,输尿管结石1例,前列腺癌肺转移1例,膀胱癌1例,鼻咽癌+直肠癌1例,脑血栓1例,急性心肌梗死+脑梗塞1例。死亡6例,其中：因原发性肺癌死亡3例,因前列腺癌骨转移死亡2例,因急性心肌梗死死亡1例。
5无生化复发生存分析随访时长3～126个月,平均33个月,中位24个月。共10人分别于术后第3到105个月时失随访。生化复发37例,分别按患者术前初始PSA水平、术中双侧NVB处理方式、术中淋巴结转移情况、手术切缘情况、术后病理分期、术后Gleason评分进行单因素分析,不同水平的无生化复发生存时间的差异具有统计学意义；多因素COX回归分析显示,手术切缘情况(HR=3.666,95%CI1.550～8.671)、术后Gleason评分(HR=1.446,95%CI1.140-1.834)、术前初始PSA水平(HR=1.014,95%CI1.004～1.025)是生化复发的独立预测因素。
研究结论
初步研究表明,免缝扎DVC技术与缝扎DVC技术相比,简化了手术步骤,不增加出血与输血风险,学习曲线较短,易于掌握,且由于钳夹的牵拉作用而使得处理DVC时术野较为开阔,更好的暴露了前列腺尖部,且一定程度上降低了伤及尿道括约肌的风险；对于合理选择的患者,保留双侧NVB有利于术后尿控的早期恢复；术前PSA与术后Gleason评分及术后病理分期均呈显著的正相关关系,表明术前PSA对于预测术后Gleason评分及术后病理分期有积极意义；手术切缘情况、术后Gleason评分及术前初始PSA水平是生化复发的独立预测因素。
Background
Prostate cancer (PCa) is one of the most common malignant tumors in male genitourinary system. The morbidity is relatively high in old male, and it is a big threat against people's health and life. Radical prostatectomy (RP) is currently the most commonly used therapeutic option for treating localized PCa which is defined as stage cT2or lower with no metastasis in preoperative time for the good results, long time survival, and acceptable incidence of both short-term and long-term complications[1]. In the past, it is not recommended for locally advanced PCa which is defined as stage cT3tumor to undergo RP because of the significantly increased rate of positive margin, unpredictable metastasis of extremital lymph nodes and the distant metastasis. While a few studies showed that RP maybe also benefit to those patients, although it has been still widerspread controversy in recent years[2]. Most scholars believed that RP is not a good choice for stage cT4, metastasis of lymph nodes or distant metastasis PCa for the surgical procedure could only offer better evidence for staging but useless for the treatment[3]. Excitedly, a large-scale study has reported that RP maybe also benefit to the patients with metastasis of lymph nodes which could increase cancer specific survival[4].
One of the key points of controlling hemorrhage is the reasonable deal with dorsal vascular complex (DVC) in surgical procedure. Most scholars believed that ligation of DVC could be effectively, while a recent retrospective research shown that ligation-free is also feasible with the development of technology, without increased rate of bleeding or blood transfusion during and after the operation. Moreover, another study showed that selective ligature of the DVC after its section is contribute to early recovery of continence.
With the development of medical technology, radical prostatectomy has been a reliable, effective treatment method for PCa. But some problems are worth while pondering and should be improved. First, Surgical treatment of pathological stage T3(or beyond) PCa, or with lymphatic metastasis, has always been a controversial issue, it is necessary and could be helpful for future multi-center meta-analysis to continuously study. Secondly, as a less applied technique, it is urgent to evaluate the safety, feasibility and superiority of DVC ligation free. What's more, it is necessary to continuously explore the following several questions:first, the relationship between neurovascular bundle (NVB) preservation and its effect on micturition control; second, the correlation between preoperative prostate specific antigen (PSA), postoperative gleason scores and pathological stages;third, the independent predictive factors of biochemical recurrence, and so on.
Objective
A total of125patients' preoperative clinical data, perioperative data, intraoperative and postoperative complications, biochemical recurrence-free survival time, time of death and lost to follow-up and outcome were analyzed statistically so as to explore the following several questions:first, the safety, feasibility and superiority of DVC ligation free; second, the relationship between NVB preservation and its effect on micturition control; third, the correlation between PSA, postoperative gleason scores and pathological stages. Survival analyses were made by using the kaplan-meier method to clarify the influence of several different factors on biochemical recurrence-free survival time. Furthermore, to explore the independent predictive factors of biochemical recurrence by using the method of cox regression. By means of a series of above studies, we expect to provide statistical bases for establishing more reasonable operative indications, improving the method, effect of operation and life quality of the patients after operation. What's more, it could provide single-center research datas for some controversial issues all over the world.
Methods
It was a retrospective series case study. A total of125patients'follow-up information were analyzed statistically. All of the patients underwent radical prostatectomy from february2002to february2013in Zhujiang Hospital, Southern Medical University. The cases diagnosed by pathological result preoperatively and postoperatively, with complete clinical data and a follow-up time more than3months.
1Perioperative data collection We collected all the patients' perioperative datas by means of clinic doctor workstation, Jiahe computer-based patient record system and case record department. These datas include:①the preoperative datas: basic information, first onset symptoms, international prostate symptom score, body mass index, american society of anesthesiologists grade, underlying diseases and accompanying diseases, PSA, fPSA/PSA (%), clinical stage, gleason scores, treatment history, continence, erectile function (just for the patients younger than70years old with satisfactory erectile function);②the intraoperative datas:the date, methods, time, blood loss of operation, volume of blood transfusion, number of pelvic lymph nodes which were dissected, treatments of NVB and DVC, surgical margin and intraoperative complications (include severe emorrhage, heart and lung failure, injury of rectal, bladder, ureter, obturator nerve and so on);③the postoperative datas:gleason score, pathological stage, preserved time of installing catheter, perioperative complications (refers to the postoperative complications which occurred before discharge, include severe hemorrhage, pulmonary infection, heart and lung failure, urinary fistula, intestinal fistula, vesicourethral anastomosis stenosis, urethral stenosis, incontinence, deep vein thrombosis, pulmonary embolism, poor wound healing, lymphocystis and so on), treatments.
2Methods of postoperative follow-up datas collection Set up the operation time and postoperative follow-up schedule table for each patient. Follow-up were scheduled every3months in the first2years and every6months in the third to fifth year, and once a year afterwards. Inform the patients who didn't return back to the hospital on time due to different reasons by telephone dialogues or e-mail. We asked the patients who unable to return back to our hospital to follow-up in the local hospital and send the results to us by means of telephone, text messages, photos, letters, e-mail and so on. Make sure of the integrity and reliability of follow-up datas by effective communication and record them in detail. Regard the patients who lost contact with us or extremely unwilling to cooperate with follow-up to loss of follow-up.
3Postoperative follow-up datas These datas include:①follow-up date;②datas within3months after surgery, include:PSA, fPSA/tPSA, maximum flow rate, average flow rate, chest film, abdominal plain film, abdominal b-ultrasound, pelvic MRI, whole-body bone imaging, postoperative recurrence and metastasis, biochemical recurrence, early complications (include postoperative severe hemorrhage, pulmonary infection, heart and lung failure, urinary fistula, intestinal fistula, vesicourethral anastomosis stenosis, urethral stenosis, incontinence, deep vein thrombosis, pulmonary embolism, poor wound healing, lymphocystis, death and so on), pad test results in early postoperative period, treatments, loss to follow-up and death (we indicate the reasons);③datas of three months after operation, include: PSA, fPSA/tPSA, maximum flow rate, average flow rate, chest film, abdominal plain film, abdominal b-ultrasound, pelvic MRI, whole-body bone imaging, postoperative recurrence and metastasis, biochemical recurrence, early complications (include vesicourethral anastomosis stenosis, urethral stenosis, incontinence, erectile dysfunction and so on), pad test results in early postoperative period, treatments, loss to follow-up and death (we indicate the reasons). Therein, erectile function were evaluated just for the patients younger than70years old with satisfactory erectile function preoperative.
4Methods of statistical analysis SPSS18.0for windows software package was used for statistical analysis.a=0.05was considered significant. Descriptive statistics data were expressed by frequency or mean+standard deviation. Comparison of rates between two groups were done by chi-squared test or fisher's exact test, and means were compared by t test. Comparisons of rates among multiple groups were performed using chi-squared test. Spearman rank correlation was used for correlation analysis between ranked data. Kruskal-Wallis H test was used for the difference comparison of some index between unordered data and ranked data, Wilcoxon rank sum test was used for further pairwise comparison (bonferroni was used to adjust α level, a'=0.05/n). Recurrence free survival curves were plotted by kaplan-meier method and compared by the log-rank test. Multivariate survival analysis was performed using cox regression model.
Results
1Prelimiray clinical effects of technique of DVC ligation free37cases (29.6%) in the group of DVC ligation free while88cases (70.4%) in the group of DVC ligation, the mean operative time was199.5min vs213.6min (t=-1.180, P=0.240), the average bleeding amount was209.5ml vs205.0ml(t=0.111, P=0.912), the average blood transfusion volume was148.7ml vs130.7ml (t=0.408, P=0.685), the transfusion rate was32.4%vs43.2%(χ2=1.254, P=0.263).
2The relationship between early continence with different treatments of NVB In the operation, NVB was not preserved in58cases (46.4%), unilateral NVB was preserved in27cases (21.6%) and bilateral NVB were both preserved in40cases (32.0%). The continence rates in three different treatments were respectively70.7%,81.5%,97.5%, not completely consistent (χ2=11.334, P=0.003). The pad test results showed that it is not completely consistent in three different treatments in3months after surgery by means of Kruskal-Wallis H test and Wilcoxon rank sum test (χ2=25.686, P=0.000), while the mean rank order were respectively77.19,61.83,43.21. According to the mean rank order, we inferred that the group of no NVB preserved need most pads in the early postoperative period, the group of unilateral NVB preserved take second place, and then is the group of bilateral NVB preserved. There was no statistical difference between the first two groups (P=0.046>0.025), whlie significant difference was observed between the first and the third group (P=0.000<0.025), and the third group needs less pads. There was also statistical difference between the second and the third group (P=0.006<0.025), and the third group needs less pads. By using the method of spearman rank correlation, it showd that there was a significant negative correlation between the degree of NVB preservation and pads demanding in the early postoperative period (rs=-0.453, P=0.000).
3The relationship among preoperative PSA levels, postoperative gleason scores and pathological stages Preoperative PSA:<4.0ng/ml,8cases (6.4%);4.0～10.0ng/ml38cases(30.4%);10.0～20.0ng/ml,34cases(27.2%);>20ng/ml, 45cases (36.0%). Postoperative gleason scores:2-6,67cases (53.6%);7,27cases (21.6%);8,19cases (15.2%);9～10,12cases (9.6%). Postoperative pathological stages:pTl,14cases (11.2%); pT2,75cases (60.0%); pT3,34cases (27.2%); pT4,2cases(1.6%). By using the method of spearman rank correlation, it showd that there is a significant positive relationship between preoperative PSA levels and postoperative gleason scores (rs=0.345, P=0.000), so as preoperative PSA levels and postoperative pathological stages (rs=0.284, P=0.001). Meanwhile, there is a significant positive relationship between postoperative gleason scores and pathological stages (rs=0.642, P=0.000).
4Early postoperative complications and long-term outcome Totally57person-time in49patients had10kinds of early complications. Among them: incontinence (at the time of3months after catheter removal),23cases; urinary tract infection,11cases; poor wound healing,7cases; urinary fistula,5cases; urethral stenosis,3cases; vesicourethral anastomosis stenosis,3cases; intestinal fistula,2cases; epididymitis,1case; pulmonary infection,1case; penis and lower extremity lymphoedema,1case. Two and more than two kinds of early complications occurred in7cases:urinary fistula and incontinence,3cases; urinary tract infection and epididymitis,1case; incontinence and poor wound healing,1case; urethral stenosis and vesicourethral anastomosis stenosis,1case; incontinence, urinary tract infection, penis and lower extremity lymphoedema,1case. The continence rates of3months,1year and5years postoperative were respectively81.6%,96.1%,100%. International index of erectile function-5(IIEF-5) were used to evaluate the erectile function for the patients younger than70years old with satisfactory erectile function preoperative,21cases of which were normal and the other42cases were slightly erectile dysfunction. By the end of the follow-up period, recovery of erectile function was found in25cases (39.7%). Among them,2of25cases (8.0%) whose NVB was not preserved,6of12cases (50.0%) whose unilateral NVB were preserved and17of25cases (65.4%) whose bilateral NVB were both preserved had recovered, respectively. Long-term outcome:12cases suffered from bone metastasis,10cases suffered from vesicourethral anastomosis stenosis,5cases suffered from indirect inguinal hernia,5cases suffered from urethral stricture,3cases suffered from vesical calculus,3cases suffered from primary lung cancer,1case suffered from urinary tract infection,1case suffered from calculus of ureter,1case suffered from lung metastasis,1case suffered from bladder cancer,1case suffered from nasopharyngeal cancer and colon-rectal cancer,1case had cerebral thrombosis,1case suffered from acute myocardial infarction and cerebral infarction.6cases died,3of which died of primary lung cancer,2of which died of bone metastasis and1of which died of acute myocardial infarction.
5Bio-chemical recurrence free survival analysis Follow-up time ranged from3to126months (mean33months, median24months). Ten patients were lost to follow-up at the time of3rd to105th month postoperation.37cases had bio-chemical recurrence. By single factor analysis, the postoperative bio-chemical recurrence survival time were statistically significant difference among different preoperative PSA, treatments of NVB, lymphatic metastasis, surgical margin, postoperative pathological stages and gleason scores. By multivariate cox regression analysis, surgical margin (HR=3.666,95%CI1.550-8.671), postoperative gleason scores (HR=1.446,95%CI1.140～1.834) and preoperative PSA (HR=1.014,95%CI1.004～1.025) were independent risk factors for the bio-chemical recurrence.
Conclusion
Preliminary studies showed that the technique of DVC ligation free is an alternative processing method of DVC which is unlikely to increase the risk of bleeding or transfusion compared to DVC ligation, and the former one seems not only much simpler to practise and grasp, but also have a better surgical field and better exposure of the prostate apex because of the help of the tractive force by the pincers. The preservation of bilateral NVB for suitable patients is beneficial for early recovery of urinary continence postoperation. There is a significant positive relationship between preoperative PSA levels and postoperative gleason scores, so as preoperative PSA levels and postoperative pathological stages. The results indicate that preoperative PSA levels is vital to the forecast the postoperative gleason scores and pathological stages. High postoperative gleason score is a independent risk factor of positive surgical margin. Surgical margin, postoperative gleason scores and preoperative PSA were independent risk factors for the bio-chemical recurrence.
前列腺癌是泌尿生殖系统最常见的恶性肿瘤之一,好发于老年男性,严重威胁生命健康。对于早期局限性前列腺癌,即术前评估肿瘤分期在cT2期以内、无转移灶的患者,前列腺癌根治术的肿瘤治疗效果确切,患者术后可望获得长期生存,且近远期并发症的发生率多在可接受的范围,被认为是首选的治疗方案[1]；对于局部进展期前列腺癌,即cT3期患者,由于术后切缘阳性的可能性明显增加,且可能存在难以评估的淋巴结转移或远处转移,既往并不被推荐行根治性手术治疗,但近年来有限的文献(包括一些前瞻性研究)报道,患者行前列腺癌根治术仍有可能获益,尽管这一观点在不同的研究者和研究中心具有较大的争议,但仍表明了根治性手术治疗在针对局部进展期前列腺癌患者的治疗中具有一定的地位[2]；而对于cT4期及伴有淋巴结转移或远处转移的任何分期的患者,大多数学者认为不予行前列腺癌根治术而转为内分泌治疗和(或)放射治疗,因为手术仅能为肿瘤的分期提供依据而对肿瘤的治疗并无益处。但目前国外有大规模研究表明,即使对于伴有淋巴结转移的前列腺癌患者,行前列腺癌根治术仍可提高其肿瘤特异性生存率,研究者认为根治性手术对于前列腺癌淋巴结转移患者仍然可获益。
在手术过程中,阴茎背血管复合体(Dorsal Vascular Complex, DVC)的合理处理是控制出血的关键之一。国内外大多数学者认为,缝扎DVC可以有效的控制出血。另有研究认为,DVC的处理方式对术后尿控的恢复速度有一定的影响。选择性缝扎,即在切断DVC后根据必要性进行缝扎,要比常规的先缝扎后切断能获得更高的术后早期尿控率。最近的一项回顾性研究认为,随着手术器械的发展,免缝扎DVC技术也是可行的,其并不增加术中及术后出血和输血的风险[6。
随着医疗技术的发展,前列腺癌根治术是一项已趋成熟的手术方式,且治疗效果令人满意。但是,仍存在一些值得关注或争议较大的问题,例如：对于pT3期及以上,或已有淋巴结转移的前列腺癌患者的根治性手术的意义,国内外研究数据极其有限,且各研究者的结论有较大的争议,尚待更多的研究中心提供数据予以充实,亦可为将来多中心的荟萃分析提供文献支持；作为一项应用较少的技术,免缝扎DVC技术的安全性、可行性以及是否具有优越性仍亟待研究；关于前列腺两侧血管神经束(Neurovascular Bundle, NVB)的保留对尿控的影响,术前血清初始前列腺特异性抗原(Prostate Specific Antigen, PSA)水平与术后Gleason评分及病理分期的相关性问题,以及生化复发的独立预测因素等问题,均亟待研究探讨或充实。
研究目的
对纳入研究的所有患者的术前临床资料、围手术期临床资料、术中与术后并发症、无生化复发生存时间、失访与死亡时间、结局等临床资料进行统计学描述与分析,初步探讨免缝扎DVC技术的安全性、可行性及优越性与否；阐明前列腺两侧NVB的保留对尿控的影响；探讨术前PSA对于预测术后Gleason评分及病理分期的意义；基于以上资料,应用Kaplan-Meier法进行生存分析,分别阐明不同因素对无生化复发生存时间的影响；进一步行Cox多因素回归分析,探讨生化复发的独立危险因素。通过以上一系列研究,期待为更合理确定手术适应症、改进手术方式、提高肿瘤治疗效果及患者术后生存质量提供统计学依据,并为国际上尚存争议的一些问题提供单中心研究数据。
研究方法
本研究属于回顾性临床研究。统计南方医科大学附属珠江医院泌尿外科自2002年2月至2013年2月,接受前列腺癌根治术、术前及术后病理均证实为前列腺癌,且获得规律随访时间超过3个月、临床资料完整的125例患者的随访资料。
1围手术期资料收集通过南方医科大学附属珠江医院医生工作站、嘉禾电子病历系统及病案室查询纸质病历三种方式复习病案,收集患者的围手术期临床资料,包括：①术前资料：患者基本信息、首发症状、国际前列腺症状评分、体重指数、美国麻醉师协会麻醉分级、伴发基础疾病情况、术前初始PSA、fPSA/PSA(%).肿瘤临床分期、肿瘤Gleason评分(包括主要评分与次要评分)、治疗史、控尿情况、阴茎勃起功能(仅针对年龄≤70岁,术前阴茎勃起功能满意,有性生活需求的患者)；②术中：手术日期、手术方式、手术时长、出血量、输血量、盆腔淋巴结清扫情况、双侧NVB处理方式、DVC处理方式、切缘情况、术中并发症(包括术中严重出血、心肺功能衰竭、直肠损伤、膀胱损伤、输尿管损伤、闭孔神经损伤等)；③术后：包括术后Gleason评分(包括主要评分与次要评分)、术后病理分期、留置尿管天数、围手术期并发症(指患者手术后至出院前所出现的并发症,亦属于术后早期并发症范畴,包括：术后严重出血、肺部感染、心肺功能衰竭、尿瘘、肠瘘、膀胱尿道吻合口狭窄、尿道狭窄、尿失禁、深静脉血栓、肺栓塞、切口脂肪液化或感染等原因造成的愈合不良、淋巴囊肿等)、术后治疗情况。
2术后随访资料收集方法建立患者的手术时间与术后随访计划表。患者出院时,嘱其在术后2年内每3个月返院复查1次,2年后每6个月返院复查1次,5年后每1年返院复查1次。对于因各种原因没有按时返院复查的患者,及时通过电话或邮件的方式通知对方返院复查；对于确实无法或无意愿返院复查的患者,嘱其在当地医院就近复查相关项目后,将检查及检验报告以电话、短信、照片、信件或电子邮件等方式予以及时反馈,并通过有效的沟通以确保随访资料的完整性与可靠性,作好详实的登记；对于联系电话、通讯地址等信息变更后未能联系上的患者,以及极其不愿配合随访而失去联系的患者,按失随访处理。
3术后随访指标包括：①随访日期；②术后早期(术后3个月内)资料,包括：血清PSA水平、fPSA/tPSA、最大尿流率、平均尿流率、胸部平片、腹部平片、腹部B超(包括肝胆胰脾及泌尿系统)、盆腔MRI、全身骨显像、肿瘤复发与转移情况、生化复发情况、术后并发症(包括：术后严重出血、肺部感染、心肺功能衰竭、尿瘘、膀胱尿道吻合口狭窄、尿道狭窄、尿失禁、深静脉血栓、肺栓塞、切口脂肪液化或感染等原因造成的愈合不良、淋巴囊肿、死亡等)、术后全天需要使用的尿垫数量、术后治疗情况、失随访与死亡情况(注明原因)；③术后远期(术后3个月后)资料,包括：血清PSA水平、fPSA/tPSA、最大尿流率、平均尿流率、胸部平片、腹部平片、腹部B超(包括肝胆胰脾及泌尿系统)、盆腔MRI、全身骨显像、肿瘤复发与转移情况、生化复发情况、术后并发症(包括：膀胱尿道吻合口狭窄、尿道狭窄、尿失禁、阴茎勃起功能障碍等)、术后全天需要使用的尿垫数量、术后治疗情况、失随访与死亡情况(注明原因)。其中,阴茎勃起功能的评估与术前对应,即仅针对年龄≤70岁,术前阴茎勃起功能满意,有性生活需求的患者。
4统计学分析方法所有的资料均采用SPSS18.0统计软件处理,检验水准α=0.05。描述性统计结果以频数(f)或均数±标准差(X±S)表示；两独立组间率的比较采用χ2检验或Fisher精确概率检验；多个独立组间率的比较采用χ2检验,两均数的比较采用两独立样本t检验；两有序等级资料之间的相关性研究采用Spearman等级相关法；分组变量无序,评价指标变量有序,评价不同组别某指标之间是否有差别采用Kruskal-Wallis H检验,并进一步使用VVilcoxon秩和检验比较两组间差异,采用Bonferroni法对检验水准进行校正,α=0.05/比较次数。应用Kaplan-Meier法绘制无生化复发生存曲线,采用Log-rank检验分别比较单因素不同水平的生存曲线差异性。多因素分析使用Cox比例风险模型,以筛选生化复发的预测因素。
研究结果
1免缝扎DVC技术临床效果的初步探讨免缝扎DVC组37例(29.6%),缝扎DVC组88例(70.4%),平均手术时间199.5分钟vs213.6分钟(t=-1.180,P=0.240),平均出血量209.5ml vs205.0ml(t=0.111,P=0.912),平均输血量148.7ml vs130.7ml(t=0.408,P=0.685),输血率32.4%vs43.2%(χ2=1.254,P=0.263)。
2NVB的处理方式与尿控术中未保留NVB58例(46.4%),保留单侧NVB27例(21.6%),保留双侧NVB40例(32.0%)。未保留NVB、保留单侧NVB、保留双侧NVB三种处理方式术后3个月时的控尿率分别为：70.7%、81.5%、97.5%,不完全一致(χ2=11.334,P=0.003)；对于术后3个月时的全天尿垫数量,Kruskal-Wallis H检验与Wilcoxon秩和检验示：三种不同的NVB处理方式,术后早期全天尿垫数量是不全相同的(χ2=25.686,P=0.000),平均秩次依次为：77.19、61.83、43.21；根据平均秩次进一步推测：不保留NVB者术后早期全天需要使用的尿垫数量最多,保留单侧NVB者次之,而保留双侧NVB者使用的尿垫数量最少。但不保留NVB与保留单侧NVB的差别无统计学意义(P=0.046>0.025),而与保留双侧NVB的差别具有统计学意义(P=0.000<0.025),后者使用的尿垫数量较少；保留单侧NVB与保留双侧NVB的差别具有统计学意义(P=0.006<0.025),后者使用的尿垫数量较少。Sperman等级相关检验示,血管神经束保留程度与术后早期全天使用尿垫数量呈显著的负相关关系(rs=-0.453,P=0.000)。
3术前PSA与术后Gleason评分及病理分期的关系术前PSA水平：<4.0ng/ml者8例(6.4%),4.0～10.0ng/ml者38例(30.4%),10.0～20.0ng/ml者34例(27.2%),>20ng/ml者45例(36.0%)；术后Gleason评分：2-6分67例(53.6%),7分27例(21.6%),8分19例(15.2%),9-10分12例(9.6%)；术后病理分期：pTl期14例(11.2%),pT2期75例(60.0%),pT3期34例(27.2%),pT4期2例(1.6%)。Sperman等级相关检验示：术前PSA与术后Gleason评分呈显著的正相关关系(rs=0.345,P=0.000)；术前PSA与术后病理分期的呈显著的正相关关系(rs=0.284,P=0.001)；术后Gleason评分与术后病理分期呈显著的正相关关系(rs=0.642,P=0.000)。
4术后早期并发症与远期转归共发生手术相关性早期并发症10种,49人共发生并发症57例次。其中：尿失禁23例(拔除尿管3个月时评估)、尿路感染11例、切口愈合不良7例、尿瘘5例、尿道狭窄3例、吻合口狭窄3例、肠瘘2例、附睾炎1例、肺部感染1例、阴茎伴下肢淋巴水肿1例。其中,7人发生2种及2种以上的并发症：尿瘘合并尿失禁3例,尿路感染合并附睾炎1例,尿失禁合并切口愈合不良1例,尿道狭窄伴吻合口狭窄1例,尿失禁合并尿路感染及阴茎及下肢淋巴水肿1例。术后3个月时,控尿率为81.6%；术后1年时,控尿率为96.1%；术后5年时,控尿率为100%。对于年龄≤70岁,术前阴茎勃起功能满意,有性生活的63例患者,术前按勃起功能国际问卷-5评估勃起功能：21人勃起功能正常,其余42人有轻度的勃起功能障碍；随访至今,有25人(39.7%)恢复了自我满意的阴茎勃起功能,其中：25例未保留NVB的患者中有2例(8.0%),12例保留了单侧NVB的患者中有6例(50.0%),26例保留了双侧NVB的患者中有17例(65.4%)。远期转归或结局：前列腺癌骨转移12例,膀胱尿道吻合口狭窄10例,腹股沟斜疝5例,尿道狭窄5例,膀胱结石3例,原发性肺癌3例,尿路感染1例,输尿管结石1例,前列腺癌肺转移1例,膀胱癌1例,鼻咽癌+直肠癌1例,脑血栓1例,急性心肌梗死+脑梗塞1例。死亡6例,其中：因原发性肺癌死亡3例,因前列腺癌骨转移死亡2例,因急性心肌梗死死亡1例。
5无生化复发生存分析随访时长3～126个月,平均33个月,中位24个月。共10人分别于术后第3到105个月时失随访。生化复发37例,分别按患者术前初始PSA水平、术中双侧NVB处理方式、术中淋巴结转移情况、手术切缘情况、术后病理分期、术后Gleason评分进行单因素分析,不同水平的无生化复发生存时间的差异具有统计学意义；多因素COX回归分析显示,手术切缘情况(HR=3.666,95%CI1.550～8.671)、术后Gleason评分(HR=1.446,95%CI1.140-1.834)、术前初始PSA水平(HR=1.014,95%CI1.004～1.025)是生化复发的独立预测因素。
研究结论
初步研究表明,免缝扎DVC技术与缝扎DVC技术相比,简化了手术步骤,不增加出血与输血风险,学习曲线较短,易于掌握,且由于钳夹的牵拉作用而使得处理DVC时术野较为开阔,更好的暴露了前列腺尖部,且一定程度上降低了伤及尿道括约肌的风险；对于合理选择的患者,保留双侧NVB有利于术后尿控的早期恢复；术前PSA与术后Gleason评分及术后病理分期均呈显著的正相关关系,表明术前PSA对于预测术后Gleason评分及术后病理分期有积极意义；手术切缘情况、术后Gleason评分及术前初始PSA水平是生化复发的独立预测因素。
Background
Prostate cancer (PCa) is one of the most common malignant tumors in male genitourinary system. The morbidity is relatively high in old male, and it is a big threat against people's health and life. Radical prostatectomy (RP) is currently the most commonly used therapeutic option for treating localized PCa which is defined as stage cT2or lower with no metastasis in preoperative time for the good results, long time survival, and acceptable incidence of both short-term and long-term complications[1]. In the past, it is not recommended for locally advanced PCa which is defined as stage cT3tumor to undergo RP because of the significantly increased rate of positive margin, unpredictable metastasis of extremital lymph nodes and the distant metastasis. While a few studies showed that RP maybe also benefit to those patients, although it has been still widerspread controversy in recent years[2]. Most scholars believed that RP is not a good choice for stage cT4, metastasis of lymph nodes or distant metastasis PCa for the surgical procedure could only offer better evidence for staging but useless for the treatment[3]. Excitedly, a large-scale study has reported that RP maybe also benefit to the patients with metastasis of lymph nodes which could increase cancer specific survival[4].
One of the key points of controlling hemorrhage is the reasonable deal with dorsal vascular complex (DVC) in surgical procedure. Most scholars believed that ligation of DVC could be effectively, while a recent retrospective research shown that ligation-free is also feasible with the development of technology, without increased rate of bleeding or blood transfusion during and after the operation. Moreover, another study showed that selective ligature of the DVC after its section is contribute to early recovery of continence.
With the development of medical technology, radical prostatectomy has been a reliable, effective treatment method for PCa. But some problems are worth while pondering and should be improved. First, Surgical treatment of pathological stage T3(or beyond) PCa, or with lymphatic metastasis, has always been a controversial issue, it is necessary and could be helpful for future multi-center meta-analysis to continuously study. Secondly, as a less applied technique, it is urgent to evaluate the safety, feasibility and superiority of DVC ligation free. What's more, it is necessary to continuously explore the following several questions:first, the relationship between neurovascular bundle (NVB) preservation and its effect on micturition control; second, the correlation between preoperative prostate specific antigen (PSA), postoperative gleason scores and pathological stages;third, the independent predictive factors of biochemical recurrence, and so on.
Objective
A total of125patients' preoperative clinical data, perioperative data, intraoperative and postoperative complications, biochemical recurrence-free survival time, time of death and lost to follow-up and outcome were analyzed statistically so as to explore the following several questions:first, the safety, feasibility and superiority of DVC ligation free; second, the relationship between NVB preservation and its effect on micturition control; third, the correlation between PSA, postoperative gleason scores and pathological stages. Survival analyses were made by using the kaplan-meier method to clarify the influence of several different factors on biochemical recurrence-free survival time. Furthermore, to explore the independent predictive factors of biochemical recurrence by using the method of cox regression. By means of a series of above studies, we expect to provide statistical bases for establishing more reasonable operative indications, improving the method, effect of operation and life quality of the patients after operation. What's more, it could provide single-center research datas for some controversial issues all over the world.
Methods
It was a retrospective series case study. A total of125patients'follow-up information were analyzed statistically. All of the patients underwent radical prostatectomy from february2002to february2013in Zhujiang Hospital, Southern Medical University. The cases diagnosed by pathological result preoperatively and postoperatively, with complete clinical data and a follow-up time more than3months.
1Perioperative data collection We collected all the patients' perioperative datas by means of clinic doctor workstation, Jiahe computer-based patient record system and case record department. These datas include:①the preoperative datas: basic information, first onset symptoms, international prostate symptom score, body mass index, american society of anesthesiologists grade, underlying diseases and accompanying diseases, PSA, fPSA/PSA (%), clinical stage, gleason scores, treatment history, continence, erectile function (just for the patients younger than70years old with satisfactory erectile function);②the intraoperative datas:the date, methods, time, blood loss of operation, volume of blood transfusion, number of pelvic lymph nodes which were dissected, treatments of NVB and DVC, surgical margin and intraoperative complications (include severe emorrhage, heart and lung failure, injury of rectal, bladder, ureter, obturator nerve and so on);③the postoperative datas:gleason score, pathological stage, preserved time of installing catheter, perioperative complications (refers to the postoperative complications which occurred before discharge, include severe hemorrhage, pulmonary infection, heart and lung failure, urinary fistula, intestinal fistula, vesicourethral anastomosis stenosis, urethral stenosis, incontinence, deep vein thrombosis, pulmonary embolism, poor wound healing, lymphocystis and so on), treatments.
2Methods of postoperative follow-up datas collection Set up the operation time and postoperative follow-up schedule table for each patient. Follow-up were scheduled every3months in the first2years and every6months in the third to fifth year, and once a year afterwards. Inform the patients who didn't return back to the hospital on time due to different reasons by telephone dialogues or e-mail. We asked the patients who unable to return back to our hospital to follow-up in the local hospital and send the results to us by means of telephone, text messages, photos, letters, e-mail and so on. Make sure of the integrity and reliability of follow-up datas by effective communication and record them in detail. Regard the patients who lost contact with us or extremely unwilling to cooperate with follow-up to loss of follow-up.
3Postoperative follow-up datas These datas include:①follow-up date;②datas within3months after surgery, include:PSA, fPSA/tPSA, maximum flow rate, average flow rate, chest film, abdominal plain film, abdominal b-ultrasound, pelvic MRI, whole-body bone imaging, postoperative recurrence and metastasis, biochemical recurrence, early complications (include postoperative severe hemorrhage, pulmonary infection, heart and lung failure, urinary fistula, intestinal fistula, vesicourethral anastomosis stenosis, urethral stenosis, incontinence, deep vein thrombosis, pulmonary embolism, poor wound healing, lymphocystis, death and so on), pad test results in early postoperative period, treatments, loss to follow-up and death (we indicate the reasons);③datas of three months after operation, include: PSA, fPSA/tPSA, maximum flow rate, average flow rate, chest film, abdominal plain film, abdominal b-ultrasound, pelvic MRI, whole-body bone imaging, postoperative recurrence and metastasis, biochemical recurrence, early complications (include vesicourethral anastomosis stenosis, urethral stenosis, incontinence, erectile dysfunction and so on), pad test results in early postoperative period, treatments, loss to follow-up and death (we indicate the reasons). Therein, erectile function were evaluated just for the patients younger than70years old with satisfactory erectile function preoperative.
4Methods of statistical analysis SPSS18.0for windows software package was used for statistical analysis.a=0.05was considered significant. Descriptive statistics data were expressed by frequency or mean+standard deviation. Comparison of rates between two groups were done by chi-squared test or fisher's exact test, and means were compared by t test. Comparisons of rates among multiple groups were performed using chi-squared test. Spearman rank correlation was used for correlation analysis between ranked data. Kruskal-Wallis H test was used for the difference comparison of some index between unordered data and ranked data, Wilcoxon rank sum test was used for further pairwise comparison (bonferroni was used to adjust α level, a'=0.05/n). Recurrence free survival curves were plotted by kaplan-meier method and compared by the log-rank test. Multivariate survival analysis was performed using cox regression model.
Results
1Prelimiray clinical effects of technique of DVC ligation free37cases (29.6%) in the group of DVC ligation free while88cases (70.4%) in the group of DVC ligation, the mean operative time was199.5min vs213.6min (t=-1.180, P=0.240), the average bleeding amount was209.5ml vs205.0ml(t=0.111, P=0.912), the average blood transfusion volume was148.7ml vs130.7ml (t=0.408, P=0.685), the transfusion rate was32.4%vs43.2%(χ2=1.254, P=0.263).
2The relationship between early continence with different treatments of NVB In the operation, NVB was not preserved in58cases (46.4%), unilateral NVB was preserved in27cases (21.6%) and bilateral NVB were both preserved in40cases (32.0%). The continence rates in three different treatments were respectively70.7%,81.5%,97.5%, not completely consistent (χ2=11.334, P=0.003). The pad test results showed that it is not completely consistent in three different treatments in3months after surgery by means of Kruskal-Wallis H test and Wilcoxon rank sum test (χ2=25.686, P=0.000), while the mean rank order were respectively77.19,61.83,43.21. According to the mean rank order, we inferred that the group of no NVB preserved need most pads in the early postoperative period, the group of unilateral NVB preserved take second place, and then is the group of bilateral NVB preserved. There was no statistical difference between the first two groups (P=0.046>0.025), whlie significant difference was observed between the first and the third group (P=0.000<0.025), and the third group needs less pads. There was also statistical difference between the second and the third group (P=0.006<0.025), and the third group needs less pads. By using the method of spearman rank correlation, it showd that there was a significant negative correlation between the degree of NVB preservation and pads demanding in the early postoperative period (rs=-0.453, P=0.000).
3The relationship among preoperative PSA levels, postoperative gleason scores and pathological stages Preoperative PSA:<4.0ng/ml,8cases (6.4%);4.0～10.0ng/ml38cases(30.4%);10.0～20.0ng/ml,34cases(27.2%);>20ng/ml, 45cases (36.0%). Postoperative gleason scores:2-6,67cases (53.6%);7,27cases (21.6%);8,19cases (15.2%);9～10,12cases (9.6%). Postoperative pathological stages:pTl,14cases (11.2%); pT2,75cases (60.0%); pT3,34cases (27.2%); pT4,2cases(1.6%). By using the method of spearman rank correlation, it showd that there is a significant positive relationship between preoperative PSA levels and postoperative gleason scores (rs=0.345, P=0.000), so as preoperative PSA levels and postoperative pathological stages (rs=0.284, P=0.001). Meanwhile, there is a significant positive relationship between postoperative gleason scores and pathological stages (rs=0.642, P=0.000).
4Early postoperative complications and long-term outcome Totally57person-time in49patients had10kinds of early complications. Among them: incontinence (at the time of3months after catheter removal),23cases; urinary tract infection,11cases; poor wound healing,7cases; urinary fistula,5cases; urethral stenosis,3cases; vesicourethral anastomosis stenosis,3cases; intestinal fistula,2cases; epididymitis,1case; pulmonary infection,1case; penis and lower extremity lymphoedema,1case. Two and more than two kinds of early complications occurred in7cases:urinary fistula and incontinence,3cases; urinary tract infection and epididymitis,1case; incontinence and poor wound healing,1case; urethral stenosis and vesicourethral anastomosis stenosis,1case; incontinence, urinary tract infection, penis and lower extremity lymphoedema,1case. The continence rates of3months,1year and5years postoperative were respectively81.6%,96.1%,100%. International index of erectile function-5(IIEF-5) were used to evaluate the erectile function for the patients younger than70years old with satisfactory erectile function preoperative,21cases of which were normal and the other42cases were slightly erectile dysfunction. By the end of the follow-up period, recovery of erectile function was found in25cases (39.7%). Among them,2of25cases (8.0%) whose NVB was not preserved,6of12cases (50.0%) whose unilateral NVB were preserved and17of25cases (65.4%) whose bilateral NVB were both preserved had recovered, respectively. Long-term outcome:12cases suffered from bone metastasis,10cases suffered from vesicourethral anastomosis stenosis,5cases suffered from indirect inguinal hernia,5cases suffered from urethral stricture,3cases suffered from vesical calculus,3cases suffered from primary lung cancer,1case suffered from urinary tract infection,1case suffered from calculus of ureter,1case suffered from lung metastasis,1case suffered from bladder cancer,1case suffered from nasopharyngeal cancer and colon-rectal cancer,1case had cerebral thrombosis,1case suffered from acute myocardial infarction and cerebral infarction.6cases died,3of which died of primary lung cancer,2of which died of bone metastasis and1of which died of acute myocardial infarction.
5Bio-chemical recurrence free survival analysis Follow-up time ranged from3to126months (mean33months, median24months). Ten patients were lost to follow-up at the time of3rd to105th month postoperation.37cases had bio-chemical recurrence. By single factor analysis, the postoperative bio-chemical recurrence survival time were statistically significant difference among different preoperative PSA, treatments of NVB, lymphatic metastasis, surgical margin, postoperative pathological stages and gleason scores. By multivariate cox regression analysis, surgical margin (HR=3.666,95%CI1.550-8.671), postoperative gleason scores (HR=1.446,95%CI1.140～1.834) and preoperative PSA (HR=1.014,95%CI1.004～1.025) were independent risk factors for the bio-chemical recurrence.
Conclusion
Preliminary studies showed that the technique of DVC ligation free is an alternative processing method of DVC which is unlikely to increase the risk of bleeding or transfusion compared to DVC ligation, and the former one seems not only much simpler to practise and grasp, but also have a better surgical field and better exposure of the prostate apex because of the help of the tractive force by the pincers. The preservation of bilateral NVB for suitable patients is beneficial for early recovery of urinary continence postoperation. There is a significant positive relationship between preoperative PSA levels and postoperative gleason scores, so as preoperative PSA levels and postoperative pathological stages. The results indicate that preoperative PSA levels is vital to the forecast the postoperative gleason scores and pathological stages. High postoperative gleason score is a independent risk factor of positive surgical margin. Surgical margin, postoperative gleason scores and preoperative PSA were independent risk factors for the bio-chemical recurrence.
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