透明帽辅助内镜下硬化术与吻合器痔上黏膜环切钉合术治疗内痔的临床对照研究

Cap-assisted endoscopic sclerotherapy and procedure for prolapse and hemorrhoids for internal hemorrhoids:a randomized controlled study

目的比较透明帽辅助内镜下硬化术(cap-assisted endoscopic sclerotherapy, CAES)与吻合器痔上黏膜环切钉合术(procedure for prolapse and hemorrhoids, PPH)治疗内痔的有效性与安全性。方法本研究为前瞻性双盲对照临床研究。将保定市第一中心医院2018年3月-2020年3月收治的80例符合纳入且不符合排除标准的内痔患者以随机数字表法分成CAES组(n=40)和PPH组(n=40), 分别接受不同的手术方式。比较两组围手术期相关指标, 包括术中出血量、手术时间、术后24 h和48 h疼痛视觉模拟量表(visual analogue scale, VAS)评分、住院时间、治疗费用、恢复正常生活时间、治愈率。比较两组术后3个月并发症情况和术后1年复发情况。结果受试者均顺利完成手术。与PPH组相比, CAES组术中出血量[(0.54±0.15)mL比(7.32±2.17)mL]和治疗费用[(6 249.53±435.67)元比(7 832.96±526.74)元]均显著减少(t=19.714, P<0.05;t=14.650, P<0.05), 住院时间[(3.53±0.94)d比(5.18±1.36)d]和恢复正常生活时间[(5.26±1.28)d比(7.17±2.09)d]均显著缩短(t=6.312, P<0.05;t=4.929, P<0.05)。两组手术时间对比差异无统计学意义(t=0.977, P>0.05)。CAES组术后24 h[(2.64±0.70)分比(3.59±0.93)分]、48 h[(1.28±0.31)分比(2.16±0.57)分]疼痛VAS评分均显著低于同期PPH组(t=5.162, P<0.05;t=8.578, P<0.05)。CAES组和PPH组治愈率比较差异无统计学意义[90.0%(36/40)比97.5%(39/40), χ^(2)=0.853, P=0.356]。术后3个月随访期间, CAES组尿潴留[0.0%(0/40)比15.0%(6/40)]、疼痛发生率[2.5%(1/40)比22.5%(9/40)]均显著低于PPH组(χ^(2)=4.504, P<0.05;χ^(2)=7.314, P<0.05)。80例患者均无其他并发症发生。随访1年, CAES组复发率为7.5%(3/40), 与PPH组5.0%(2/40)相比, 差异无统计学意义(χ^(2)=0.180, P>0.05)。结论 CAES作为一种治疗内痔的新型微创技术具有与PPH相当的治愈率和术后1年复发率。且与PPH相比, CAES具有创伤更小、痛苦更小、康复速度更快及费用更经济等优点。

Objective To compare the efficacy and safety of cap-assisted endoscopic sclerotherapy(CAES)and procedure for prolapse and hemorrhoids(PPH)for internal hemorrhoids.MethodsThis study was a prospective double-blind controlled clinical one,A total of 80 patients with internal hemorrhoids who visited Baoding No.1 Central Hospital from March 2018 to March 2020 and met the inclusion and did not meet exclusion criteria,were randomly divided into CAES group(n=40)and PPH group(n=40)by random number table method,and received corresponding treatment respectively.The perioperative indices of the two groups were compared,including intraoperative blood loss,operation time,visual analogue scale(VAS)score at 24 and 48 hours after operation,length of hospital stay,treatment costs,time to return to normal life,and curative rates.The complications within 3 months after operation and the 1-year recurrence after operation were also compared between the two groups.ResultsThe operation was successfully completed in all patients.The intraoperative blood loss(0.54+0.15 mL VS 7.32+2.17 mL)and treatment cost(6249.53±435.67yuanVS7832.96±526.74yuan)in CAESgroup were significantly lower than those in PPH group(t=19.714,P<0.05;/=14.650,P<0.05).The length of hospital stay(3.53±0.94 d VS 5.18±1.36 d)and time to return to normal life(5.26±1.28 d VS 7.17±2.09 d)in CAES group were significantly lower than those in PPH group(t=6.312,P<0.05;(=4.929,P<0.05).There was no significant difference in operation time between the two groups(t=0.977,P>0.05).The VAS scores at 24 h(2.64+0.70 points VS 3.59±0.93 points)and 48 h(1.28±0.31 points VS 2.16±0.57 points)afer operation in CAES group were significantlylower thanthose in PPH group(t=5.162,P<0.05;t=8.578.P<0.05).Therewasno significant difference in the curative rate[90.0%(36/40)VS 97.5%(39/40)]between CAES group and PPH group(x^(2)=0.853.P=0.356).During the follow-up period within 3 months after the operation,the incidence of urinary retention[0.0%(0/40)VS 15.0%(6/40)l and pain[2.5%(1/40)VS 22.5%(9/40)]in CAES group was significantly lower than those in PPH group(X^(2)=4.504,P<0.05;X^(2)=7.314,P<0.05).No other complications occurred in the 80 patients.After 1 year of follow-up,the recurrence rate of CAES group was 7.5%(3/40),which was not statistically different from that in PPH group[5.0%(2/40),X^(2)=0.180,P>O.05].ConclusionAs a new minimally invasive technique for the treatment of internal hemorrhoids,CAES has similar curative rate and 1-year recurrence rate to PPH.Compared with PPH,CAES shows the advantages of less trauma,less pain,faster recovery and lower cost.