摘要
研究背景肛门直肠瘘是肛周皮肤和直肠、肛管相通的一种慢性感染性管道,临床表现为反复发作的肛周感染,破溃流脓,若长期不治疗或治疗不规范以及长时间无法闭合的患者可发生肛周肛管癌性病变。饮食不规律或抵抗力的下降是易造成本类型病变的多见诱因。肛瘘不能自愈,若不治疗,会反复发作直肠肛管周围脓肿,因此必须手术治疗。到目前为止,全球范围内还缺乏肛瘘的“金标准”术式及客观的手术前后疗效评价体系。复杂性肛瘘的诊断及治疗是近年来国内外研究的一个热点。由于同一种疾病在不同年龄段,尤其是成人与婴幼儿之间有着较大差异的临床特点,因此,进一步探索婴幼儿与成年人肛瘘的疾病发病特点、相关病因、准确诊断方面的异同可能对它们的治疗提供临床指导,并对成年人肛瘘的进一步研究提供重要的理论依据。
目前国内外采取的治疗肛瘘的手术方法很多,但都存在一定的复发率和肛门功能障碍等一系列问题。手术前瘘管主干以及分支瘘管的形态诊断不明或瘘管分支管道检查欠缺、治疗方法的选择不当和达不到根治性治疗是手术后症状再次出现的重要原因。相反,手术中为了过于强调根治将瘘管周围肌性结构的清理引起肛门括约肌误伤,最终造成完全性或不完全性肛门失禁。虽然近几年来应用的瘘管旷置术和直肠粘膜瓣下移及内口修复术在治疗肛瘘中取得较好的疗效,但由于各地报道差异较大,且缺乏广泛的循证医学依据,故始终未能成为肛瘘的标准手术方式。挂线手术的优点在于有效保护深层括约肌而不至于引起大便失禁,但由于手术后反复紧线而对患者造成痛苦,故也一直没有被认为是肛瘘治疗的金标准。故探索微创生物补片治疗在肛瘘患者生活质量的提高有重要的贡献。然而,到目前为止,全球范围内尚缺乏严格的、统一的、能客观的评价各种手术方式疗效的完整体系。B超与MRI提供形态学依据、无法提供肛门括约肌的功能状态。国外应用的、依靠患者症状口述相结合的Williams评分系统或大便失禁严重性分度调查表主观性较强、受调查人的职业、被调查对象的文化程度、社会因素、环境因素、情绪心理因素等因素的影响。因此探索微创治疗的同时,积极研究肛门直肠动力学方面的检测对各种手术的疗效评价有非常的重要的实际意义。
传统手术虽然对肛瘘内口处理效果良好,但无法达到有效维护肛括约肌的正常功能,带来肛门失禁并发症。生物蛋白胶具有无副反应,无痛,操作简单,无肛门功能障碍等优点,但各地报道成功率差异较大。生物蛋白胶手术失败的主要原因为瘘管的上皮及肉芽组织清除不彻底,不能为瘘管肉芽的生长创造一个良好的条件。那么,首先探索手术方式和疗效评价体系的建立和规范化。其次,积极寻求能根治肛瘘的其他手段,既要达到根治的同时,也要有效维护肛门括约肌功能的完整性、最大限度地提高肛瘘患者的生活质量是肛瘘诊治研究的两大目标。
目的肛门直肠瘘的治疗在肛肠外科领域中是一个难题。单纯切开瘘管容易造成术后复发。由于肛门括约肌功能的完整性因根治性手术而受到破坏,术后出现大便失禁等并发症的发生。到目前为止,肛瘘各种手术方式的疗效还缺乏国际上通用的评价体系。肛瘘在不同的年龄段有着不同的临床特点。其中婴幼儿肛瘘的病程及手术方法与成年人有明显不同,故治疗效果差异较大。本课题的第一部分主要通过回顾性病例对照研究的方法对比研究婴幼儿及成人肛瘘的特点及外科治疗方法的效果,从而进一步探索婴幼儿肛瘘与成年人所不同的治疗方法,从而提高其治疗效果。第二部分中通过研究肛瘘手术前后肛肠压力学的变化,寻找反映肛瘘手术后肛门括约肌功能恢复情况的检查手段,从而诊断性评估不同类型的肛瘘手术后的治疗效果。研究的第三部分通过对比研究及观察脱细胞真皮基质生物补片手术和传统切开瘘管加直肠黏膜瓣移植内口修补术治疗肛瘘的临床疗效,观察生物补片能否提高肛瘘术后患者的生活质量,能否有效降低肛瘘的复发率,从而进一步验证脱细胞真皮基质治疗肛瘘的有效性和安全性。
方法首先对新疆医科大学第一附属医院2000年1月至2009年9月收治的102例2岁以下婴幼儿及2007年1月至2008年9月收治的84例成年人肛瘘患者的临床资料按照年龄、性别、体格检查特征、瘘管分类、治疗方式、术后复发、术后大便失禁并发症等情况进行回顾性对比分析。然后对2006年1月至2009年5月就诊并接受肛瘘手术的住院肛瘘患者138例手术前后进行了肛门直肠压力学检测,并其结果与100名免费接受此项检查的门诊健康志愿者进行比较,对比分析肛瘘患者手术前后的各项技术指标与健康志愿者的相关指标之间的差别。然后按照Williams标准对肛瘘手术前后的肛门排便功能进行评分,获得肛瘘术后肛门括约肌功能的主观指标。对比分析上述两种结果的吻合程度。最后对2008年9月至2009年12月普通综合外科住院的连续性复杂性肛瘘患者90例进行单盲分层前瞻性随机对照试验方法,随机分成两组,试验组采用脱细胞真皮基质微创手术,对照组采用瘘管切除的基础上进行直肠黏膜瓣下移内口修补术,每组45例,对术后两组患者的瘘管治愈率、肛门失禁率、肛门畸形率、疼痛评分、瘘管愈合时间及患者术后生活质量等方面进行比较。瘘管治愈的判定根据瘘管外口的成功闭合、分泌物的完全消失和肛周脓肿并发症的消失来确定。术后第2天、第2、4、6、12周及第5月进行随访复查。
结果：第一部分回顾性研究中,婴幼儿组102例中98例为男性,4例女性,其中97例曾有肛周脓肿病史。102例中91例(89.22%)病变感染源为相对应的肛隐窝。按照瘘管分类,单纯性瘘管者100例,复杂性者2例,所有的患者均接受外科手术治疗,婴幼儿组术后未见复发。成人组84例中男性50例,女性34例,常规手术治疗后有9例(10.71%)出现不同程度的大便失禁及肛门功能受损情况,5例(5.95%)出现瘘管复发。在肛门直肠测压研究中,肛瘘手术后的直肠肛门反射出现不同程度的减弱,与健康对照组比较有统计学差异,其中高位肛瘘减弱显著。而实际测压值的比较,高位肛瘘患者直肠静息压、肛管静息压和肛管收缩压均明显低于低位肛瘘组及健康对照组(P<0.01),低位肛瘘肛肠压力与健康对照组比较也有显著差异。肛瘘手术后138例患者中14例出现不同程度的肛门失禁,其中9例属高位肛瘘(肛门功能：B级5例,C级2例,D级2例),5例属低位肛瘘,均为B级。所有测压指标与Williams肛门排便功能评分结果基本吻合。出现测压明显异常者Williams评分都较低。在第三部分脱细胞真皮基质随机对照试验中的肛瘘术后试验组45例中瘘管闭合者37例(82.22%),补片脱落而施行其它治疗者4例(8.89%),脓肿发生1例(2.22%),复发2例(4.45%),失访率8.89%(4/45)。对照组中,复发13例(28.89%)。脓肿发生5例(11.11%)。在瘘管治愈率、疼痛时间、瘘管愈合时间等方面,试验组均优于对照组(p<0.05)。其中高位肛瘘的比较差别较明显。但在肛门失禁率和肛门畸形率的比较中两组无显著差别。
结论：肛瘘在不同的年龄段,尤其是婴幼儿期与成年人的临床特点显示明显不同,这种不同主要表现在肛门直肠解剖结构,临床症状以及瘘管的类型等方面。婴幼儿肛瘘单纯性者多,一次性根治手术后很少出现肛门功能受损和术后复发。而成年人瘘管复杂性多,单纯切开后复发率高,而根治性术后容易出现肛门功能不良。故成年人肛瘘应尽量应用微创性手术方法来保护肛门功能的完整性。了解这些特点对婴幼儿和成人肛瘘的治疗有重要的指导意义。第二部分研究结果显示所应用的肛门直肠测压对肛瘘手术前后肛门括约肌功能障碍的诊断性评估提供重要的客观依据,对肛瘘的临床治疗具有很重要的指导意义。在第三部分研究中,观察发现不同手术方式显示不同的疗效差异。其中,脱细胞真皮基质微创手术是闭合复杂性肛瘘内口的有效方法。这种方法治疗肛瘘的成功率为82.22%(37/45),明显高于传统单纯切开加直肠黏膜瓣下移内口修补手术,至于此方法治疗失败可能与补片放置操作有关。复杂性肛瘘的治疗中,脱细胞真皮基质手术应为首选治疗方法。然而,这种方法对高位肛瘘的疗效需要进一步更多的多中心随机对照临床试验加以验证。
Backround Anorectal fistula was the kind of chronic inflammatory abnormal communications between anorectum and around the skin. Dominant clinical manifestations of long time unhealed anorectal fistula include reccurent anorectal infection, liquid secretion, suppuration or anorectal malignancy in the late stage. Irregular diet or low resistance state were the common reasons in anorectal fistula. The disease can only be managed by surgery. Or else, it likely results in abscess formation or further complications. Up to now, there was no gold standard treatment and standard management efficacy evaluation system to surgical method in the world. Nowadays comlex fistula is the hot research topic in the world. Because the same disease can be manifestated in different ages, especially in infants and adults, it is necessary to further explore the onset, related etiology and exact diagnostic difference between infant's and adult's anorectal fistula. These differences may take important role in clinical management, and can provide theoretical basis to further clinical research.
Nowadays there were numbers of surgical methods used to anorectal fistula. However, recurrence and fecal incontinence are two important unsolved problems after surgery. Difficulty of detection to main fistula tract and its branchs, improper treatment and insufficiency on fistula tract resection were most important reasons of recurrence. To the contrary, total resection of sphincter around the anus and rectum can result in fecal incontinence after surgery. Although Open incision or endorectal advancement flap have good efficiency to anorectal fistula, however, the diversity in different country could not take this method for granted. Seton surgery can preserve the anorectal sphincter function. However, repeated stringing can cause severe pain to patients after surgery. Therefore, sphincter-preseving techniques such as minimized fistula plug may improve patients life quality. However, up to now, there were no standard management efficacy evaluation system before and after surgery. Ultrasound and Magnetic Resonance Imaging can not provide dynamic states of anorectal sphincter although it has morphological basis. Williams Score System and fecal Incontinence Severity Index have subjectivity. They can be influenced by occupation, social degree, environmental conditions and psychological states of patients. The anorectal manometric study can evaluate the efficieny in different management methods of anorectal fistula.
Traditional surgery is the efficient way in the closure of fistula internal openings. But, postoperatitve incontinence was the disadvantage of it. Fibrin glue was the painless and simple sphincter preserving procedure. But, its report has regional disparity. Insufficiency of endepidermis and granulation tissue resection are the important reasons of postoperative complication. Therefore, it is essential to explore the better management method in order to improve anorectal fistula patient's life quality, and to protect normal sphincteric function of anorectal fistula patients which are the two main goals in this study.
Objective Management of anorectal fistula was the difficult point in anorectal surgery. Simple fistulectomy can result in postoperative recurrence. Sphincter resction can cause fecal incontinence. Uo to now, there were no standard management efficacy evaluation systems in the world before and after anorectal surgery. The efficacy of anorectal fistula management is closely associated with characteristics of different age and different surgical method. Anorectal fistula in infants have more difference in these characteristics and management efficacy compared with adults fistula. First part of this series study, we dominantly compare features and surgical management of anorectal fistula in infants and adults in order to find the better method of management using retrospective comparative way. The purpose of the second part of this study was to find the better diagnostic instruments which can reflect the recovery on anorectal sphincter function by using the anorectal manometric pressure changes before and after anal fistula surgery and to find the relation between anorectal manometric changes and Williams score system. The aim of the third part was to compare the efficacy and safety of Acellular Dermal Matrix bioprosthetic material and conventional fistulectomy combined with endorectal advancement flap in the treatment of anorectal fistula. This randomized controlled trial can also observate occurrence rate and patients life quality of minimized material patients.
Methods In the first part,102 pediatric anorectal fistula patients less than 2 years of age from January 2000 to September 2009 and 84 adults anorectal fistula from January 2007 to September 2008 in First Teaching Hospital of Xinjiang Medical University were reviewed retrospectively according to age, gender, physical finding, classification of fistula, postoperative occurrence and fecal incontinence, management method. In the second part,138 anorectal fistula patients and 100 healthy volunteers received anorectal manometry. Technological indexes of anal fistula patients before and after surgery were comparatively analyzed compared with that of healthy subjects. We also recorded all patients Williams anorectal incontinence severity score before and after surgery in order to compare subjective and objective parameter of these indexes. In the third part,90 consecutive in-hospital patients with complex anorectal fistulas from September 2008 through December 2009 were prospectively enrolled in randomized into two groups. Subjects were blinded about the treatment. We compared our outcomes for minimized Accellular Dermal Matrix anal fistula material and fistulectomy combined with advancement flap closure in the aspect of success rate, fecal incontinence rate, anorectal deformity rate, pain score, closure time and life quality score. Success was difined as closure of all external openings, abseence of drainage without further intervention, and absence of abscess formation. Follow-up examinations were performed at 2 days,2,4,6, and 12 weeks, and 5months after surgery.
Results hi retrospective study,98 patients in infant group were male when other 4 cases were female with mean age of 9.5 months.97 cases have the history of previous anorectal abscesses.100 infants fistulas were single which two of them were complex. Their origins in the crypts were clearly identified in 91 cases (89.22%). All patients received surgical management. No recurrences were observed after surgical treatment in infants group. In adults group,9 patients (10.71%) have fecal incontinence and rectoanal disorders in different stages after surgery, and 5 cases (5.95%) recured of anorectal fistula. In the second part of the study, anorectal reflexes of postoperative anal fistula patients weaken vary in grade. The weaking extent in hilar fistula group was obvious compared with that of lower fistula group and normal healthy subjects. Rectal resting pressure, anal resting pressure and anal squeeze pressure in hilar fistula patients were obviously lower than that of lower fistula group and normal healthy subjects. All of these indexes in lower fistula patients were obviously lower than normal healthy subjects. There were 14 cases which occurred fecal incontinence after surgery inner 138 fistula patients.9 cases inner the 14 fecal incontinence were hilar fistula (5 cases were in grade B on anal function, 2 cases were in grade C, other 2 were in grade D),and 5 of them were lower fistula (in grade B). Anorectal manometric findings fit with their corresponding Williams index scores. All manomertic abnormal patients have lower Williams index score. In the third randomized controlled trial part, the overall success rate of minimized Accellular Dermal Matrix material after 5.7 months was 37 of 45 (82.22%). Four patients (8.89%) had a plug dislodgement, and other treatments were performed. One patients had abscess formation, two fistulas recurred. Four experiment patients lost to follow up. Thirteen of 45 in controls recurred.5 patients (11.11%) received surgical drainage because of abscess formation in controls. There was significant difference in Acellular Dermal Matrix than in advancement flap closure in the aspects of success rate, pain score and closure time (ρ<0.05), especially in high transsphincteric fistula. However, there were no statistical differences between them in the aspect of fecal incontinence rate and anorectal deformity rate.
Conclusion There were distinct differences between different ages, especially in infants and adults in anorectal fistula. These differences were manifestated of anatomical, clinical, and classificational aspects. Simple type was dominant in infant's anal fistula, and fistulotomy was the effective method to them. However, for adults, simple resection can result in high occurence rate. Sphincter splitting fistulotomy in adults can result in fecal incontinence. Therefore, surgeons should guarantee normal anorectal sphincter function to use minimized surgical options in operation. Understanding of these differences between infants and adults can provide a direction to anorectal fistula management.
In the second part, we can aome to the conclusion that anorectal manometry could provide a useful objective tool for evaluating anal sphincter function before and after anal fistula surgery, it has important diagnostic significance to the clinical management of anorectal fistula surgery. In the final part, closure of the primary opening of a fistula tract using Acellular Dermal Matrix plug is an effective method of treating anorectal fistulas. The success rate for Acellular Dermal Matrix for the treatment of complex anal fistula was 82.22 percent, which is much higher than conventional fistulectomy combined with endorectal advancement flap procedure. Given the plug dislodgement was associated with the procedure. Acellular Dermal Matrix should be considered as a first line treatment for patients with complex anorectal fistula. Further randomized controlled multicenter clinical trials are needed to elucidate the efficacy to high transsphincteric anorectal fistula.
引文
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