新型可自由选择调节开环的痔上黏膜手术暴露辅助器械在痔吻合器手术中应用的临床疗效研究

Study on the clinical efficacy of a new type of freely adjustable open loop hemorrhoidal mucosa surgical exposure auxiliary instrument in hemorrhoid stapler surgery

目的:探讨可自由选择调节开环的痔上黏膜手术暴露辅助器械(专利号:ZL201822134366.4)在痔吻合器手术中的安全性及临床疗效。方法:采用回顾性队列研究方法,纳入福建中医药大学附属人民医院肛肠一科2020年3月至2020年6月行选择性痔上黏膜切除钉合术+外痔切除术的104例混合痔患者,根据术中套镜类型不同,分为52例自由可变套镜(自由组),52例传统套镜(对照组)。分析比较两组的一般资料,近期及远期疗效。结果:入组的两组病例均顺利完成手术。两组的一般资料对比差异无统计学意义(P>0.05),在近期疗效的对比中,自由组的术后急便感发生率低于对照组(9.6% vs.26.9%,χ^(2)=5.216,P=0.022),两组手术持续时间、术中出血量、术后平均疼痛评分、术后继发性大出血(>200 mL)、术后尿潴留及术后住院天数对比差异均无统计学意义(P>0.05),远期疗效对比中,自由组的术后肛门坠胀感发生率低于对照组(5.8% vs.19.2%,χ^(2)=4.038,P=0.038),两组在疗效评定对比上差异无统计学意义(P=0.3)。两者在术后1年复发率的对比上差异无统计学意义(χ^(2)=0.210,P=0.647);两组术后肛门狭窄(χ^(2)=1.040,P=0.308)及肛门失禁(P=1.0)对比,差异无统计学意义。结论:可自由选择调节开环的痔上黏膜手术暴露辅助器械在痔吻合器的手术中的使用是安全有效的,可取得良好的近远期疗效,且有更低的术后急便感及肛门坠胀感发生率,适合临床进一步推广使用。

Objective To investigate the safety and clinical efficacy of the suprahemorrhoidal mucosal surgical exposure aid(Patent No.ZL201822134366.4)with freely adjustable opening ring in hemorrhoidal anastomosis surgery.Methods A retrospective cohort study was conducted to include 104 patients with mixed hemorrhoids who underwent selective suprahemorrhoidal mucosal resection and external hemorrhoidectomy from March 2020 to June 2020 in the First Department of Anoenterology,People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine.These patients were divided into 52 cases for free variable stapling(free group)and 52 cases for traditional stapling(control group)according to the different types of intraoperative stapling.The general data,recent and long-term outcomes of the two groups were analyzed and compared.Results Both groups of enrolled cases were successfully completed the surgery.There was no statistically significant difference in the comparison of general data between the two groups(P>0.05).In the comparison of short-term efficacy,the incidence of postoperative acute bowel sensation in the free group was lower than that in the control group(9.6%vs.26.9%,χ^(2)=5.216,P=0.022).There was no statistically significant difference in the comparison of the duration of surgery,the amount of intraoperative bleeding,the average postoperative pain score,the secondary massive bleeding(more than 200 mL),postoperative urinary retention,and the number of postoperative hospital stay between the two groups(P>0.05).In the long-term efficacy comparison,the incidence of postoperative anal distension in the free group was lower than that in the control group(5.8%vs.19.2%,χ^(2)=4.038,P=0.038).The two groups had no statistical difference in the evaluation and comparison of curative effect(P=0.3).There was no statistically significant difference in the 1-year recurrence rate between the two groups(χ^(2)=0.210,P=0.647),and there was no statistically significant difference in the comparison of postoperative anal stenosis(χ^(2)=1.040,P=0.308)and incontinence(P=1.0)between the two groups.Conclusions The use of the suprahemorrhoidal mucosal surgical exposure aid with freely adjustable opening ring in hemorrhoidal anastomosis surgery is safe and effective,and can achieve good near-term and long-term results with a lower incidence of postoperative urgency and anal swelling,and is suitable for further clinical promotion.