[A comparison of colonoscopy - assisted transanal minimally invasive surgery via glove port and endoscopic submucosal dissection in the treatment of early rectal tumors].

Objective: To explore the safety and feasibility of colonoscopy - assisted transanal minimally invasive surgery via glove port (CA-TAMIS-GP) in the treatment of early rectal tumors. Methods: A total of 67 patients evaluated as early rectal tumors (adenoma limited within mucosal layer) with diameter ≤4.0 cm at Department of Anal-Colorectal Surgery, Hangzhou Third People's Hospital from July 2013 to March 2017 were prospectively enrolled in the study. Benign tumors were diagnosed by preoperative imaging in all the patients with the distance to anal edge of 4 to 20 cm. Patients were randomly divided into treatment group and the control group according to the random number table. The treatment group (n=32) underwent CA-TAMIS-GP, including 19 males and 13 females with mean age of (55.6±11.2) years and mean tumor size of (3.3±0.4) cm, while the control group (n=35) underwent endoscopic submucosal dissection (ESD, control group), including 20 males and 15 females with mean age of (52.9±12.3) years and mean tumor size of (3.4±0.5) cm. Differences of baseline data between two groups were not significant (all P>0.05). The specific method of CA-TAMIS-GP was as follows: a surgical rubber glove sleeve (No.6) was passed through the anal device; the glove was fixed at the anvil device; after fully expanding the anus, the anal sac was placed into the anus with the fingers outside; then, the cuff and the anal sac were sutured and fixed to the perianal; a well-tight glove path was established; the ultrasonic scalpel, grasper and the colonoscopy lens connected to the host platform and the electric negative pressure suction were inserted into the three finger sleeves respectively and fixed by rubber band or silk thread; the laparoscopic instruments such as the grasper and the ultrasonic scalpel were used for pulling, grasping, cutting, electrocoagulation, suturing and other operations to complete the resection of rectal lesions. Efficacy, postoperative complication and operative cost, etc. between two groups were compared using the student's t test, chi-square tests, and Fisher's exact test. Results: Operations of two groups were completed successfully without conversion to laparotomy. Histopathologic examination showed all specimens had negative margins with the surgical resection of the layer to the submucosa, and showed no significant differences between two groups (P>0.05). Compared to the control group, the operation time was shorter [(49.5±14.6) minutes vs.(66.1±17.6) minutes, t=-4.235, P<0.001], and the intraoperative hemorrhage was less [(4.2±1.6) ml vs. (6.2±2.1) ml, t=-4.349, P<0.001] in the treatment group with significant differences. In the treatment group, 6 patients had mild anal pain or discomfort after operation, and 1 patient in the control group showed anal foreign body sensation. The difference was statistically significant [18.8% (6/32) vs. 2.9% (1/35), P=0.048]. The incidence of postoperative hematochezia in the treatment group was lower than that in the control group [9.4% (3/32) vs. 20.0% (7/35), P=0.310] without significant difference. The cost of consumables in the treatment group was (1586.9±204.4) yuan, which was lower than (7694.4±1123.2) yuan in control group, and the difference was statistically significant (t=-30.880, P<0.001). All the patients were followed up for 6 to 36 months after operation, and no recurrence or long-term complication occurred in the treatment group, while 1 case developed local recurrence in the control group. Conclusion: CA-TAMIS-GP is a safe and effective method for early rectal tumors with simple and economical characteristics, which broadens the application of colonoscopy.目的： 评价结肠镜辅助手套通路经肛微创手术（CA-TAMIS-GP）治疗早期直肠肿瘤的安全性和可行性。 方法： 前瞻性纳入2013年7月至2017年3月在杭州市第三人民医院肛肠外科评估为直径≤4.0 cm的早期直肠肿瘤（病变局限于黏膜层的直肠腺瘤）患者67例。所有患者术前影像学检查评估均为良性肿瘤，距肛缘距离在4~20 cm之间。按照随机数表法，将入选患者分为两组：一组接受CA-TAMIS-GP治疗（手套通路组，32例），其中男19例，女13例，年龄（55.6±11.2）岁，肿瘤大小（3.3±0.4）cm；另一组接受内镜黏膜下剥离术（ESD组，35例），其中男20例，女15例，年龄（52.9±12.3）岁，肿瘤大小（3.4±0.5）cm；两组基线资料差异均无统计学意义，具有可比性（均P>0.05）。手套通路组的具体方法为：将6号外科橡胶手套袖套穿过扩肛器，并反折手套口将其固定于扩肛器上。充分扩肛后将扩肛器置入肛内，留指套端在肛门外，将袖套口及扩肛器缝合固定于肛周，建立气密性良好的手套通路；将超声刀、无损伤肠钳及连接主机平台和电动负压吸引的结肠镜镜头分别伸入3个指套内，并用橡皮筋及丝线固定；应用肠钳、超声刀等腹腔镜器械通过牵拉、抓取、切除、电凝、缝合等操作完成直肠病变切除。采用t检验、χ(2)检验或Fisher确切概率法，比较CA-TAMIS-GP与ESD两种术式的治疗效果、术后并发症和手术费用等情况。 结果： 两组手术均顺利完成，无中转开腹；手术切除层面均至黏膜下层，切缘均阴性。两组术后病理组织学检查差异无统计学意义（均P>0.05）。手套通路组手术时间低于ESD组[（49.5±14.6）min比（66.1±17.6）min，t=-4.235，P<0.001]；术中出血量也均低于ESD组[（4.2±1.6）ml比（6.2±2.1）ml，t=-4.349，P<0.001]；差异均有统计学意义。与ESD组比较，手套通路组术后出现肛门轻度疼痛或不适的概率更高，差异有统计学意义[18.8%（6/32）比2.9%（1/35），P=0.048]；手套通路组3例发生术后便血，发生率低于ESD组[9.4%（3/32）比20.0%（7/35），P=0.310]，但差异无统计学意义。手套通路组耗材费用（1 586.9±204.4）元，低于ESD组耗材费用（7 694.4±1 123.2）元，差异有统计学意义（t=-30.880，P<0.001）。术后随访6~36个月，手套通路组未出现术后复发或远期并发症，ESD组中有1例患者出现局部复发。 结论： 结肠镜辅助手套通路经肛微创手术是治疗直肠早期肿瘤的一种安全、有效的手术方式，并具有简便、经济的特点，同时也扩宽了结肠镜的应用范围。.