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   复旦学报(医学版)  2022, Vol. 49 Issue (5): 697-703      DOI: 10.3969/j.issn.1672-8467.2022.05.009
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后鞘后经脐缘单孔腹腔镜完全腹膜外腹股沟疝修补术:500例回顾性分析
王廷峰1 , 吴卫东2 , 陈军杰3 , 唐健松4 , 于鹤1 , 黄亮亮1 , 张一忠5     
1. 上海市浦东医院-复旦大学附属浦东医院胃肠外科 上海 201399;
2. 上海交通大学附属第一人民医院胃肠外科 上海 200080;
3. 宁波市北仑区中医院普通外科 宁波 315800;
4. 宁波市北仑区第三人民医院普通外科 宁波 315600;
5. 宁波大学医学院附属医院疝与腹壁外科 宁波 315020
摘要目的 探讨后鞘后入路,经脐缘单孔腹腔镜完全腹膜外腹股沟疝修补术(single incision laparoscopic totally extraperitoneal hernia repair,SIL-TEP)的安全性、有效性,以及术后生活质量和满意度。方法 回顾性分析2019年12月—2021年12月在4家医院施行的后鞘后入路SIL-TEP患者的临床资料,分别采用卡罗莱纳舒适量表、数值评定量表和手术切口满意测评问卷来评定生活质量、手术满意度和切口美容效果。结果 共纳入500例患者,其中男性450例、女性50例,平均手术时间:单侧56.6 min,双侧77.2 min。术中并发症中,腹膜破损150例,精索血管损伤4例,无大血管、输精管、肠管和膀胱损伤,无一例中转为常规腹腔镜手术。术后并发症中,血清肿28例,血肿5例,阴囊水肿19例,尿潴留2例,切口感染3例。术后6、24和48 h平均疼痛视觉模拟评分依次为2.6、1.7和0.6。术后半年生活质量量表中各项平均得分依次为:异物感0.008,疼痛0.016,活动受限0.002;手术满意度5分者479例,美容满意度平均9.9。平均随访13.9个月,期间疝复发3例,无切口疝和补片感染。结论 后鞘后经脐缘SIL-TEP安全可行,而且在术后疼痛、生活质量和手术瘢痕等方面能够达到令人满意的效果。
关键词腹股沟疝    单孔腹腔镜手术    完全腹膜外    后鞘后入路    
Single incision laparoscopic totally extraperitoneal inguinal hernia repair by posterior sheath approach: a retrospective analysis of 500 cases
WANG Ting-feng1 , WU Wei-dong2 , CHEN Jun-jie3 , TANG Jian-song4 , YU He1 , HUANG Liang-liang1 , ZHANG Yi-zhong5     
1. Department of Gastrointestinal Surgery, Shanghai Pudong Hospital-Fudan University Pudong Medical Center, Shanghai 201399, China;
2. Department of Gastrointestinal Surgery, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai 200080, China;
3. Department of General Surgery, Beilun District Hospital of Traditional Chinese Medicine, Ningbo 315800, Zhejiang Province, China;
4. Department of General Surgery, Beilun District Third People's Hospital, Ningbo 315600, Zhejiang Province, China;
5. Department of Hernia and Abdominal Surgery, the Affiliated Hospital of Medical School, Ningbo University, Ningbo 315020, Zhejiang Province, China
Abstract: Objective To investigate the safety, effectiveness, post-operative quality of life and satisfaction of trans-umbilical single incision laparoscopic totally extraperitoneal hernia repair (SIL-TEP) by posterior sheath approach. Methods Clinical data of patients undergoing SIL-TEP by posterior sheath approach in four hospitals from Dec 2019 to Dec 2021 were retrospectively analyzed. The quality of life, surgical satisfaction and cosmetic effect of incision were respectively evaluated by Carolina Comfort Scale, Numerical Rating Scale and "score of access-site satisfaction and consideration" questionnaire. Results A total of 500 patients were enrolled, including 450 males and 50 females. The mean operation time was 56.6 min for unilateral patients and 77.2 min for bilateral patients. There were 150 cases of peritoneum damage, 4 cases of spermatic cord vascular injury, no injury of great vessels, vas deferens, bowel and bladder, and no conversion to conventional laparoscopic surgery. Postoperative complications consisted of inguinal seroma (n=28), hematoma (n=5), scrotal edema (n=19), urinary retention (n=2) and wound infection (n=3).The mean visual analog scores of pains at 6, 24 and 48 hours postoperatively were 2.6, 1.7 and 0.6, respectively. Six months after the operation, the average scores of all items in the quality of life scale were as follows: mesh sensation 0.008, pain 0.016, movement limitation 0.002. Surgical satisfaction was 5 in 479 cases, and the average cosmetic satisfaction was 9.9. During the mean follow-up of 13.9 months, only 3 patients had recurrent hernia, and no incisional hernia or mesh infection happened in these cases. Conclusion SIL-TEP by posterior sheath approach is safe and feasible, and can achieve satisfactory results in postoperative pain, quality of life and surgical scar.
Key words: inguinal hernia    single incision laparoscopic surgery    totally extraperitoneal    posterior sheath approach    

自2008年Filipovic-Cugura等[1]报道了第1例单孔腹腔镜完全腹膜外腹股沟疝修补术(single incision laparoscopic totally extraperitoneal hernia repair,SIL-TEP),经过十余年的发展普及,SIL-TEP安全性和有效性逐渐获得学界认可[2-4]。本团队于2016年在上海市浦东医院开展首例SIL-TEP,在临床实践中发现SIL-TEP在脐缘建立初始操作空间时,可以进入后鞘后层面,并于2020年通过61例的回顾性研究阐述了该入路与常规后鞘前入路相比,具有保护腹壁结构的完整性、增加操作灵活性和降低操作难度等技术优势,是常规SIL-TEP的创新性补充[5]。目前国内外尚未见针对后鞘后SIL-TEP的进一步研究报道。本文回顾性分析了500例患者的临床资料,旨在通过总结手术并发症和复发率等指标来评估该入路的安全性和有效性,同时评价患者术后的生活质量以及对手术和术后切口美容的满意度。

资料和方法

研究对象  回顾性分析2019年12月—2021年12月在4家医院施行的后鞘后入路经脐缘SIL-TEP患者的临床资料。纳入标准:诊断为腹股沟疝(包括难复性疝)的患者,且术前均行盆腔CT检查。排除标准:心肺功能差,不能耐受全麻手术。根据纳入和排除标准,共收集整理500例患者资料,其中复旦大学附属浦东医院31例,宁波市北仑区中医院78例,宁波市北仑第三人民医院56例,宁波大学医学院附属医院335例。本研究获得以上4家医院的伦理委员会批准(伦理批件编号依次为2020-PWR-03,2022-WZ-01,L2022002和XJS20191206)。

资料收集  年龄、性别、体重指数(body mass index,BMI)、美国麻醉医师协会(American Society of Anesthesiologists,ASA)分级、疝分型(改良Gilbert分型)和合并症,包括高血压、2型糖尿病、高脂血症和慢性阻塞性肺疾病(chronic obstructive pulmonary disease,COPD)等;术中资料包括切口长度(length of incision,LoI)、手术时间、估计出血量,以及术中并发症发生情况(包括中转常规三孔腹腔镜或开放手术),术中血管、输精管、膀胱和肠管等损伤;术后资料包括视觉模拟评分(visual analogue scale,VAS)评定的疼痛评分,住院时间(hospital length of stay,LoS),以及并发症(包括切口感染、尿潴留、腹股沟区血清肿,腹膜外间隙血肿、阴囊水肿、肠梗阻、补片感染、疝复发和切口疝等)。

手术方式  采用吸入复合全身麻醉,预计手术时间较长(如双侧疝患者),术前留置尿管。患者取头低脚高15°仰卧位。选择脐下正中2~2.5 cm弧形切口,具体操作与本团队之前报道一致[5],同时遵守腹腔镜腹股沟疝手术操作指南(2017版)[6]中完全腹膜外腹股沟疝修补手术原则(图 1)。

A: A single 25-mm subumbilical incision was made, and the anterior rectus sheath was cut off transversely. B: After pulling the rectus muscle laterally, the posterior rectus sheath was cut off. C: The extraperitoneal space under the incision was dissected gradually. D and E: PORT was placed. F and G: The medial space was developed up to the Retzuis' space. H: The lateral space was developed up to the Bogros' space. I, J and K: Hernia sac was dissected off from the cord structures. L: Mesh positioning were performed, covering the inguinal floor, without fixed. 图 1 后鞘后SIL-TEP关键手术步骤展示 Fig 1 Key surgical steps of SIL-TEP through posterior rectus sheath approach

生活质量和满意度评估  采用原版卡罗莱纳舒适量表(Carolina Comfort Scale,CCS)评定生活质量[7]。CCS使用0~5评分来评估疼痛、补片异物感和活动受限。0表示“无症状”,5表示“出现功能障碍”。研究者分别于术后1周、1个月和6个月通过门诊面对面或电话的方式进行随访。

手术满意度根据数值评定量表(Numerical Rating Scale,NRS),从1(极度不满意)到5(极度满意)进行评估。切口的美容满意度采用量表进行问卷调查,按照从1到10的等级,1是“非常不满意”,5是“一般”,10是“非常满意”[8]。研究者于术后6个月进行电话随访。

统计学方法  采用描述性统计分析,计量资料用均数(范围)表示,计数资料用频数(百分比)表示。使用Excel 2010完成数据整理和分析。

结果

患者基本资料  共纳入500例患者,其中男性450例,女性50例,平均年龄58.8(18~95)岁,平均BMI为23.9(20.8~35.1)kg/m2。ASA分级1分者占73.6%。疝分型Ⅱ型者占55.3%,右侧疝占49.4%。合并症中高血压占73.7%。患者基本资料见表 1

表 1 实施SIL-TEP患者的一般资料 Tab 1 Basic information of patients underwent SIL-TEP  
(n=500)
Variable SIL-TEP approach
Gender
  Male 450(90%)
  Female 50(10%)
Age(y) 58.8(49-71)
BMI(kg/m2 23.9(22.5-25.0)
ASA
  Ⅰ 368(73.6%)
  Ⅱ 122(24.4%)
  Ⅲ 10(2%)
Hernia side
  Right 247(49.4%)
  Left 177(35.4%)
  Bilateral 76(15.2%)
Hernia type*(n=576)
  Ⅰ 16(2.8%)
  Ⅱ 319(55.4%)
  Ⅲ 84(14.6%)
  Ⅳ 46(8%)
  Ⅴ 69(12%)
  Ⅵ 20(3.5%)
  Ⅶ 22(3.8%)
Recurrent hernia 7(1.4%)
Incarcerated hernia 14(2.8%)
Comorbidity [n = 194]
  Hypertension 143(73.7%)
  Type 2 Diabetes 30(15.5%)
  Hyperlipemia 16(8.2%)
  COPD 5(2.6%)
*Modified Gilbert Classification;SIL-TEP:Single incision laparoscopic totally extraperitoneal inguinal hernia repair.

手术相关数据和术中并发症  对手术切口、手术时间、预计出血量和术中并发症进行了汇总分析。平均切口长度2.2(2~3)cm。平均手术时间59.8(26~198)min,其中双侧平均77.2(36~198)min,略长于单侧的平均56.6(26~190)min。出血量少,平均3.9(2~30)mL,无中转为三孔腹腔镜情况。所有病例中发生术中并发症的共154例(30.8%),腹膜撕裂为最常见术中并发症,共150例(30%),术中精索血管损伤4例(0.8%),无其他重要组织器官损伤(表 2)。

表 2 实施SIL-TEP患者的术中相关数据 Tab 2 Intraoperative data of patients underwent SIL-TEP
Variable SIL-TEP approach
LoI(cm) 2.2(2-3)
Mean surgical time(min)
  Overall 59.8(26-198)
  Lateral 56.6(26-190)
  Bilateral 77.2(36-198)
Mean estimated blood loss(mL) 3.9(2-30)
Complications [n=154(30.8%)]
  Conversion 0(0)
  Peritoneal tears 150(30%)
  Epigastric vessel bleeding 0(0)
  Spermatic vessel bleeding 4(0.8%)
  Corona mortis bleeding 0(0)
  Iliaca vessels bleeding 0(0)
  Seminiferous duct injury 0(0)
  Bladder injury 0(0)
  Bowl injury 0(0)

术后疼痛和并发症  术后疼痛轻微,术后6、24和48 h平均VAS分别为2.6(2~4)、1.7(0~6)和0.6(0~4)。平均住院时间(4.5±1.7)天。术后共60例(12%)患者出现并发症,常见并发症为腹股沟区血清肿,共28例(5.6%),其次为阴囊水肿19例(3.8%),切口感染3例(0.6%),伤口血肿3例(0.6%),尿潴留2例(0.4%),腹膜外间隙血肿2例(0.4%),均经保守治疗治愈。无肠梗阻和补片相关感染。平均随访13.9个月,复发3例(0.6%),无切口疝发生(表 3)。

表 3 实施SIL-TEP患者的手术后相关数据 Tab 3 Postoperative data of patients underwent SIL-TEP  
[n(%)]
Variable SIL-TEP approach
VAS
  At 6 h after surgery 2.6(2-4)
  At 24 h after surgery 1.7(0-6)
  At 48 h after surgery 0.6(0-4)
LoS(days) 4.5±1.7
Follow-up(months) 13.9(6-30)
Complications [n=60(12%)]
  Urinary retention 2(0.4)
  Seroma 28(5.6)
  Hematoma(preperitoneal space) 2(0.4)
  Wound hematoma 3(0.6)
  Wound infection 3(0.6)
  Scrotal oedema 19(3.8)
  Intestinal obstruction 0(0)
  Mesh infection 0(0)
  Incisional hernia 0(0)
  Recurrence 3(0.6)

生活质量和满意度  术后1周、1个月和6个月通过CCS量表进行生活质量评价,异物感、疼痛和活动受限平均得分均较低。术后6个月,手术满意度调查显示,给予5分的患者为479例,占95.8%;对手术切口(图 2)的美容满意度平均分为9.9分。以上表明患者术后生活质量,以及对手术和切口满意度均较高(表 4)。

A: Preoperative incision location; B: Intraoperative incision; C: Incision scar 1 week after surgery; D: Incision scar 1 month after surgery. 图 2 实施SIL-TEP患者手术切口的变化 Fig 2 Surgical incision changes of patients who underwent SIL-TEP
表 4 患者术后6个月随访时的生活质量和满意度 Tab 4 Postoperative quality of life, surgical and cosmetic satisfaction at 6-month follow-up  
[n(%)]
Variable* SIL-TEP approach
Sensation of mesh
  At 1 week after surgery 1.599(0-4)
  At 1 month after surgery 0.510(0-3)
  At 6 months after surgery 0.008(0-4)
Pain
  At 1 week after surgery 1.375(0-3)
  At 1 month after surgery 0.362(0-2)
  At 6 months after surgery 0.016(0-2)
Movement limitation
  At 1 week after surgery 0.900(0-3)
  At 1 month after surgery 0.300(0-2)
  At 6 months after surgery 0.002(0-1)
Surgical satisfaction(1-5)
  Very satisfied(5) 479(95.8)
  Satisfied(4) 17(3.4)
  Average satisfied(3) 3(0.6)
  Not satisfied(2) 1(0.2)
  Extremely dissatisfied(1) 0(0)
Cosmetic satisfaction(1-10) 9.9(10-10)
*Evaluated by Carolina Comfort Scale(CCS).
讨论

随着腹腔镜腹股沟疝修补术的应用日益普遍和成熟,医师和患者对微创的要求也越来越高。SIL-TEP具有隐藏瘢痕和对腹腔内脏器干扰少的优势,而且相对于SIL-TAPP操作更为简单,因此临床推广更为广泛[9]。经脐缘的SIL-TEP有2种入路:腹直肌后鞘前和后鞘后。前者放置单孔操作平台(port)较容易,但是存在以下不足:切口偏患侧,美观性略差,port容易扭曲或滑脱,影响操作;双侧疝时对白线破坏较大;一旦术中发生腹膜破损后,腹膜上抬,而因后鞘外侧较为固定造成空间进一步压缩,对手术影响大。而后鞘后入路,有效地弥补了以上缺点,我们团队于2020年聚焦该入路的技术优势进行了首次报道[5]。本次综合多中心500例样本的回顾性研究结果显示:除术中腹膜撕裂外,整体并发症发生率低,且无严重并发症发生;同时,患者术后的生活质量高,对手术和切口瘢痕的美容效果满意,复发率低,进一步表明了后鞘后SIL-TEP安全有效,可以获得较高的患者满意度。

新技术在开展过程中,需要经历学习曲线才能达到稳定的手术时间并确保手术的安全性。从手术时间和成功率角度分析,SIL-TEP的学习曲线与常规TEP基本相同。Park等[10]报道完成约60例SIL-TEP后可达到稳定的手术时间,手术成功率 > 90%;完成约85例时手术时间可稳定在35 min。本研究单侧疝修补平均手术时间56.6 min,长于上述报道,可能与全新入路的手术方式和学习曲线有关;同时,平均双侧手术时间为77.2 min,并未显著延长,体现了该入路治疗双侧疝的优势。后鞘后入路在初始游离放置port的腹膜外空间时容易出现腹膜破损而延长手术时间,但是SIL-TEP可在直视下进行腹膜前间隙的分层分区操作,使操作更加精准,有利于减少并发症。因为术者均具有丰富的SIL-TEP操作经验,所以单侧平均手术时间与Wakasugi等[11]报道的接近。在本研究中,总并发症发生率为30.8%,明显高于文献报道[12]。但需要说明的是,术中腹膜撕裂发生率30%,为主要并发症,与Dapri等[13]的研究结果接近;并未发生大血管、膀胱和肠管等损伤的严重并发症,体现了手术的安全性[3]。如前所述,后鞘后入路初始空间建立时容易发生腹膜撕裂,但伴随采用特制的小号port,进一步掌握鞘后层面解剖和手术操作经验的积累会逐渐降低腹膜撕裂发生率,而一旦顺利进入后鞘与腹横筋膜间的正确层面,腹膜的破损不会明显增加手术难度,这是后鞘后入路的优势之一,也是本研究中无中转常规腹腔镜的原因之一。我们在之前发表的文章中就如何化解后鞘后入路腹膜破损给操作造成的困难作了详细的介绍[5]。在血管损伤方面,本研究纳入的病例均未出现腹壁下血管、死亡冠血管及髂血管的损伤,优于Dapri等[13]的研究结果。本研究中无肠管、输精管和膀胱损伤,以往报道中脏器损伤亦属罕见[14]

Lee等[14]报道的1 231例后鞘前SIL-TEP术后并发症发生率为8.6%,本研究为12%,其中血清肿和阴囊水肿为术后主要并发症,发生率分别为5.6%和3.8%。荟萃分析显示术后血清肿发生率为2.9%~11%[4],单中心2 148例SIL-TEP报道血清肿发生率为6%[15],与本研究接近。因纳入的患者中有14.6%的Ⅲ型腹股沟疝患者,可能与上述并发症发生率较高有关,但均经保守治疗治愈,无须再次手术。单孔手术切口并发症备受关注。国内11家医院10 808例经脐单孔妇科手术的临床资料显示:脐部切口并发症发生率为1.18%,其中切口疝发生率为0.1%,切口感染发生率为0.93%[16]。国际多项荟萃分析提示,与常规腹腔镜手术相比,SILS后切口疝发生率明显增加,为1.69~2.20%[17-18],但这些分析并未纳入单孔腹腔镜腹股沟疝修补术的相关研究,Dapri等[13]报道后鞘前SIL-TEP术后切口疝发生率为0.5%,明显低于上述报道。SIL-TEP鞘后入路需要切开白线和前后鞘,理论上脐部切口疝风险增加,但是本研究平均随访13.9个月,无切口疝发生,原因可能在于较常规腹腔镜手术大的切口有助于术者在直视下确切关闭脐部筋膜组织。本研究切口感染发生率为0.6%,切口血肿发生率为0.6%,可能与长时间的手术操作、port对皮肤切口组织的压迫、局部组织血供差、组织抗感染的能力下降等有关。

虽然荟萃分析显示,在术后疼痛方面SIL-TEP是否优于常规三孔TEP尚存在争议[12, 19]。本研究中术后6、24和48 h的VAS平均评分分别为2.6、1.7和0.6,与Chia等[20]研究结果接近,但由于研究的局限性,尚不能得出与常规三孔TEP相比是否具有优势的结论。本研究首次采用CCS量表从疼痛、补片异物感和活动受限3方面评估后鞘后SIL-TEP患者术后的生活质量,发现随着术后恢复时间的延长,患者的主观不适感明显下降,术后6个月3项指标平均得分接近于零,结果与文献的报道一致[21]。同时患者对切口的美观度也给予了高分评价。在此基础上,95.8%的患者对手术的满意度评价给予了满分,与荟萃分析结果一致[4, 12]

本研究的局限性在于:虽然是目前为止后鞘后SIL-TEP样本量最大的报道,但未将其与后鞘前SIL-TEP或者常规三孔TEP进行比较,使研究结果缺乏一定的说服力。

综上,经脐缘后鞘后SIL-TEP安全可行,而且在术后疼痛、生活质量和手术瘢痕等方面能够达到令人满意的效果,具有推广价值。但是本研究结果仍需高质量的临床随机对照研究加以论证。

作者贡献声明  王廷峰  获取资助,实施手术,数据整理,统计分析,撰写论文。吴卫东  研究设计,手术指导,论文指导及修订,可行性分析。陈军杰,唐健松  实施手术,数据收集和整理。于鹤  数据收集和整理。黄亮亮  数据分析和制图。张一忠  手术指导,研究设计,可行性分析,论文指导及修订。

利益冲突声明  所有作者均声明不存在利益冲突。

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文章信息

王廷峰, 吴卫东, 陈军杰, 唐健松, 于鹤, 黄亮亮, 张一忠
WANG Ting-feng, WU Wei-dong, CHEN Jun-jie, TANG Jian-song, YU He, HUANG Liang-liang, ZHANG Yi-zhong
后鞘后经脐缘单孔腹腔镜完全腹膜外腹股沟疝修补术:500例回顾性分析
Single incision laparoscopic totally extraperitoneal inguinal hernia repair by posterior sheath approach: a retrospective analysis of 500 cases
复旦学报医学版, 2022, 49(5): 697-703.
Fudan University Journal of Medical Sciences, 2022, 49(5): 697-703.
Corresponding author
ZHANG Yi-zhong, E-mail: 55539310@qq.com.
基金项目
上海市卫健委临床研究项目(202040116);上海市浦东新区卫生系统学科带头人培养计划(PWRd2020-19);上海市浦东新区卫健委临床特色学科项目(PWYts2021-01)
Foundation item
This work was supported by the Clinical Research Project of Shanghai Municipal Health Commission (202040116), the Academic Leaders Training Plan of Health System in Pudong New Area, Shanghai (PWRd2020-19) and the Clinical-special Discipline Project of Pudong New Area Health Committee of Shanghai (PWYts2021-01)

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