Huang Hua, Tao Liu, Jiang Jie, Wei Jun, Ji Lijiang
Department of Anorectal Surgery, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, 215500, PR China.
Department of Anorectal Surgery, Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, 215500, PR China.
Asian J Surg. 2023 Feb;46(2):807-815. doi: 10.1016/j.asjsur.2022.07.149. Epub 2022 Aug 10.
This study aimed to compare the efficiency of these two combined surgeries [prolapse and hemorrhoids (PPH) combined with the external hemorrhoidectomy and inferior internal hemorrhoid ligation; tissue selecting technique with mega-window stapler (TST-MS) combined with anal canal epithelial preservation operation].
This is a single-center, evaluator-blinded randomized controlled trial (RCT). A total of 204 participants were randomly divided into the two groups. The anal function, reoccurrence, intraoperative variables, and operative complications were assessed. The measurement data were compared by paired t test and rank sum test. Chi-squared or Fisher's exact test was used for count data and rank sum test for ranked data. To assess differences within each group in different time points, the repeated-measures analysis of variance was conducted.
TST-MS combined with anal canal epithelial preservation operation had lower Wexner score of anal incontinence (Z = 3.062, P = 0.002), higher patients' satisfaction degree (t = 7.32, P < 0.001), less residual skin tags (χ = 18.141, P < 0.001), longer operative time (Z = -2.281, P = 0.023), and bigger volume of excised rectal mucosa (t = 2.35, P = 0.020). There was no significant difference between the two groups in the anal canal circumference, recurrence, intraoperative blood loss, weight of excised rectal mucosa, anal pain, bleeding, urinary retention, anal edge edema, and anatomical anal stenosis (all P > 0.05).
TST-MS combined with anal canal epithelial preservation operation showed better clinical efficiency in the treatment of prolapsed hemorrhoids.
This study has been registered in Chinese Clinical Trial Registry (ChiCTR2000038533).
本研究旨在比较这两种联合手术[吻合器痔上黏膜环切术（PPH）联合外痔切除术及内痔低位结扎术；组织选择性吻合器痔上黏膜环切术（TST-MS）联合肛管上皮保留术]的疗效。
这是一项单中心、评估者盲法随机对照试验（RCT）。共204名参与者被随机分为两组。评估肛门功能、复发情况、术中变量及手术并发症。计量资料采用配对t检验和秩和检验进行比较。计数资料采用卡方检验或Fisher确切概率法，等级资料采用秩和检验。为评估每组在不同时间点的差异，进行重复测量方差分析。
TST-MS联合肛管上皮保留术的肛门失禁Wexner评分较低（Z = 3.062，P = 0.002），患者满意度较高（t = 7.32，P < 0.001），残留皮赘较少（χ = 18.141，P < 0.001），手术时间较长（Z = -2.281，P = 0.023），切除直肠黏膜量较大（t = 2.35，P = 0.020）。两组在肛管周长、复发、术中出血量、切除直肠黏膜重量、肛门疼痛、出血、尿潴留、肛缘水肿及肛管解剖性狭窄方面差异均无统计学意义（均P > 0.05）。
TST-MS联合肛管上皮保留术在治疗脱垂性痔方面显示出更好的临床疗效。
本研究已在中国临床试验注册中心注册（ChiCTR2000038533）。
