劈开乳头式与直接吻合式输尿管-肠道新膀胱吻合方法的前瞻性临床随机对照研究

Prospective randomized controlled trial of two ureteroileal anastomosis： split-cuff nipple vs. direct anastomosis

目的比较劈开乳头式与直接吻合式输尿管-肠道新膀胱吻合术的疗效及安全性。方法选取2014年12月至2017年3月收治的膀胱癌患者行根治性膀胱切除-原位回肠新膀胱术。采用自身配对对照、随机信封分组方法，将同一患者左、右侧输尿管-肠道新膀胱吻合术式分为劈开乳头式（A组）和直接吻合式（B组）。采用机器人辅助或腹腔镜手术在腔内完成淋巴结清扫及膀胱切除后，在体外构建M形原位回肠新膀胱。A组将输尿管末端纵行剖开0.5 cm，外翻并固定2～3针形成乳头，置入单J管。在储尿囊上切除一块圆形的浆肌层和黏膜组织，将乳头置入肠壁开口0.5 cm，用4-0可吸收线固定4～6针。B组将输尿管末端剖开0.5 cm，在储尿囊上切除一块圆形的浆肌层组织和黏膜，用可吸收线先将输尿管与储尿囊黏膜对黏膜全层连续缝合一半，置入单J管后再连续缝合余下的输尿管全层与储尿囊全层。两侧均放置单J管引流10～12 d。结果本研究共纳入70例患者，男63例，女7例。年龄（62.5±10.4）岁。70例术后中位随访时间13.2个月，1例术后3个月出现双侧输尿管狭窄，1例术后6个月出现劈开乳头吻合侧狭窄，2例分别于术后6、12个月出现直接吻合侧狭窄。术后A组6例肾输尿管出现反流，B组21例肾输尿管出现反流，反流率分别为8.6%和30.0%（P＝0.004）；A组反流的临界压力为（23.5±9.0）cmH2O（1 cmH2O＝0.098 kPa），B组为（15.5±4.9） cmH2O（P＝0.042）。术后12个月A组和B组GFR分别为（38.1±7.6） ml/min和（38.6±12.9） ml/min（P〉0.05）。术后2周A组22例和B组17例发生肾积水；随访12个月A组20例和B组14例肾积水消失（P〉0.05）。A组和B组分别有1例和4例发生急性肾盂肾炎（P〉0.05），分别有4例和1例发生肾结石（P〉0.05）。A组和B组的吻合时间分别为（8.8±3.5）min和（6.7±1.5）min（P＝0.037）。所有患者均未发生输尿管-新膀胱吻合口尿瘘。结论与直接吻合术式相比，劈开乳头吻合术式的抗反流效果好，可明显减少原位回肠新膀胱的输尿管反流发生率。劈开乳头吻合术式所用时间稍长于直接吻合术式，两者在狭窄率、肾积水、分侧肾小球滤过率，以及急性肾盂肾炎、结石和尿瘘等并发症方面无明显差异。

ObjectiveTo compare split-cuff nipple and direct ureteroileal anastomosis during ureteroileal anastomosis.MethodsBetween December, 2014 and March, 2017, a prospective randomized study was conducted on 70 patients who underwent radical cystectomy and urinary diversion. In every patient, both ureters were randomized to be implanted using an antireflux, split-cuff nipple technique （group A） or a reflux, direct technique （group B）. After pelvic lymph node dissection and radical cystectomy, a M-shape orthotopic ileal neobladder was constructed and two ureters were implanted with single-J tubes placed for 10-12 days. For split-cuff nipple technique, a 0.5 cm longitudinal incision in the ureter was made, and the ureteral wall was turned back on itself, construction a nipple. The cuff was stabilized at the corners with sutures. The ureter was then placed into the bowel with 0.5 cm nipple. The ureter was sutured to the full thickness of the bowel wall with interrupted 4-0 PDS. For direct technique, a 0.5 cm incision in the ureter was made, the full thickness of the ureter was sewn to the mucosa of the bowel.Results70 patients were enrolled in the study, 63 males and 7 females, （62.5±10.4） years old. Over a median follow-up of 13.2 months, one patients had bilateral anastomosis stricture 3 months after operation, 1 patient in group A had stricture 6 months after operation, 2 patients in group B had stricture 6 and 12 months after operation, respectively. Six patients （8.6%） in group A found reflux compared with 21 patients （30.0%） in group B （P=0.004）. The reflux pressure was （23.5±9.0） cmH2O and （15.5±4.9） cmH2O in group A and group B （P=0.042）, respectively. The GFR of group A was （38.1±7.6） ml/min compared with （38.6±12.9） ml/min in group B at 12 months after operation. One patient in group A and four patients in group B had acute nephropyelitis. Four patients in group A had renal stones formation compared with 1 patients in group B. The time of anastomosis was （8.8±3.5） minutes and （6.7±1.5） minutes （P=0.037） for group A and group B, respectively. The patients in both groups had no urine leakage.ConclusionCompared with direct technique, split-cuff nipple technique had lower reflux rate, higher antireflux pressure and longer anastomosis time than direct technique.