经肛全直肠系膜切除与腹腔镜全直肠系膜切除术后患者的肠道功能:基于随机临床研究的比较
Comparison of postoperative bowel function between patients undergoing transanal and laparoscopic total mesorectal excision
摘要目的 对比经肛全直肠系膜切除术(taTME)与腹腔镜全直肠系膜切除术(腹腔镜TME)对患者术后远期肠道功能的影响.方法 采用回顾性队列研究方法,分析2016年4月至2017年11月期间,于中山大学附属第六医院结直肠肛门外科入组TaLaR随机临床研究(NCT02966483)的直肠癌患者临床资料,纳入18~80岁、肿瘤下缘距肛缘≤10 cm、术前分期为T1~3NxM0的单发直肠腺癌患者,并排除肿瘤局部复发或全身多发转移、行腹会阴切除术、未关闭造口或重新造口、术后(或还纳后)<1年、以及术前肛门功能差或失禁者,根据手术入路分为taTME组和腹腔镜TME组.taTME组采取经肛经腹同步联合入路方法,上下两组同时进行.采用低前切除综合征(LARS)量表评估两种术式对患者术后肠道功能的影响,0~20分为"无LARS",21~29分为"轻度LARS",30~42分为"重度LARS".将手术入路作为重点变量纳入logistic模型,进行LARS发生风险的单因素和多因素分析.结果 共107例直肠癌患者被纳入本研究,其中54例接受taTME手术(taTME组),53例接受腹腔镜TME手术(腹腔镜TME组).54例taTME组患者中男35例,中位年龄57.5(26.0~77.0)岁,22例肿瘤高度<5 cm;53例腹腔镜TME组患者中男35例,中位年龄62.0(33.0~73.0)岁,25例肿瘤高度<5 cm.两组年龄、性别、术前肿瘤TNM分期、肿瘤高度等一般临床资料差异无统计学意义(均P>0.05).两组均顺利完成手术,除taTME组预防性造口比例低于腹腔镜TME组[37.0%(20/54)比64.2%(34/53), χ2=7.866,P=0.005]外,两组手术时间、术中出血量、术后吻合口并发症、术后住院时间等情况比较,差异均无统计学意义(均P>0.05).术后随访12.1~30.4(中位数17.2)个月,107例患者中,27例(25.2%)无LARS,32例(29.9%)轻度LARS,48例(44.9%)重度LARS.taTME组与腹腔镜TME组术后总体肠道功能差异无统计学意义[重度LARS比例:48.1%(26/54)比41.5%(22/53),Z=-0.994, P=0.320].与腹腔镜TME组相比,taTME组患者发生排粪后1 h再次排粪(簇状排粪)比例较高[≥1次/周比例分别为68.5%(37/54)比45.3%(24/53)],差异具有统计学意义(Z=-2.354,P=0.019).但两组在气体失禁、稀粪失禁、排粪次数和急迫排粪方面差异无统计学意义(均P>0.05).多因素logistic回归分析显示,术前放疗(OR=5.073,95% CI :1.336~19.259,P=0.017)和吻合口高度较低(OR=3.633,95% CI :1.501~8.802,P=0.004)是重度LARS的独立危险因素,taTME手术并不增加LARS的风险(OR=1.442,95%CI :0.638~3.261,P=0.379).结论 taTME与腹腔镜TME的术后远期患者的肠道功能相当,术前放疗和吻合口高度,而非手术入路,是术后重度肠道功能障碍的独立危险因素.
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abstractsObjective To compare the effects of transanal total mesorectal excision (taTME) and laparoscopic total mesorectal excision (laparoscopic TME) on patients′postoperative long?term bowel function. Methods A retrospective cohort study was used in this study. We analyzed the clinical data of 134 patients with locally advanced mid?low rectal cancer, who underwent transanal TME or laparoscopic TME in the TaLaR randomized controlled trial at the Sixth Affiliated Hospital, Sun Yat?sen University from April 2016 to November 2017. Inclusion criteria included age of 18 to 80 years old, distance from tumor low margin to anal edge ≤10 cm, preoperative staging of T1?3NxM0, and single rectal adenocarcinoma. Exclusion criteria included local recurrence, distant metastases, abdominoperineal resection, unreduced stoma, new stoma, less than 1 year after protectomy or stoma reduction, or preoperative poor anal function or incontinence. Patients were divided into taTME group and laparoscopic TME group. The taTME group received hybrid transanal and transabdominal approach performed simultaneously. The effects of surgical procedures on postoperative bowel function were evaluated with LARS (low anterior resection syndrome) scale, where 0?20 was defined as"no LARS", 21?29 as"minor LARS", and 30?42 as"major LARS". Univariate and multivariate logistic regression analyses were performed to determine the risk factors associated with major LARS, with surgical approach as a pre?selected variate. Results A total of 107 patients were included. Of the 54 patients in the taTME group, 35 were male, median age was 57.2 (26.0?77.0) years old, and 22 cases had a tumor less than 5 cm from anal verge. Of the 53 patients in the laparoscopic TME group, 35 were male, median age was 62.0 (33.0?73.0) years old, and 25 cases had a tumor less than 5 cm from anal verge. All baseline clinical data including age, gender, preoperative staging, and tumor height were comparable between the two groups (all P>0.05). All operations in both groups were performed successfully. The operation time, intra?operative blood loss, postoperative anastomotic complication, postoperative hospital stay were comparable between the two groups (all P>0.05), except for a lower diverting stoma rate in the taTME group [37.0% (20/54) vs. 64.2% (34/53), χ2=7.866, P=0.005]. Of the 107 patients, 27 (25.2%) had no LARS, 32 (29.9%) had minor LARS, and 48 (44.9%) had major LARS, after a median follow?up of 17.2 (12.1?30.4) months. No significant difference was found between the two groups in overall bowel function [major LARS: 48.1% (26/54) vs. 41.5% (22/53), Z=-0.994, P=0.320]. Compared with the laparoscopic TME group, the taTME group experienced worse clustering of stools [68.5% (37/54) vs. 45.3% (24/53), Z=-2.354, P=0.019]. However, there were no significant differences between the two groups in terms of gas incontinence, liquid stool incontinence, frequency of defecation, and urgency (all P>0.05). Multivariate analysis identified preoperative radiotherapy (OR=5.073, 95% CI: 1.336 to 19.259, P=0.017) and anastomotic height (OR=3.633, 95% CI: 1.501 to 8.802, P=0.004) as independent risk factors for major LARS, but no impact of taTME on LARS (OR=1.442, 95% CI: 0.638 to 3.261, P=0.379). Conclusions Compared with laparoscopic TME, taTME has similar outcomes of postoperative long?term bowel function. Preoperative radiotherapy and anastomotic height, but not surgical approach, are independent risk factors for postoperative bowel function.
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