Abstract：
OBJECTIVE: A notable advantage of laparoscopic colorectal surgery is that only a small incision at the extraction site is necessary, which is considered to be cosmetically beneficial. Meanwhile, the optimal extraction site for the resected specimen in laparoscopic colectomy is controversial in terms of cosmetic benefit. This randomized controlled trial compares midline and off-midline extraction sites in laparoscopic colectomy in patients with colon cancer, with consideration of cosmetic benefits as the primary endpoint.
METHODS: Included were patients that underwent elective laparoscopic colectomy at WMUH between October 2014 and February 2017. Patients were randomly assigned to either midline incision group or off-midline incision group. Prospectively collected data included cosmetic results (patients and observer assessment scale) and complications including incidence of incisional hernia, SSI, and pain. This trial was registered with UMIN Clinical Trials (UMIN000028943).
RESULTS: Finally, 98 patients with colorectal cancer were analyzed. No significant differences were found between the two groups in patient and observer assessment scales of cosmetic results (midline 8 ± 1.1 vs off-midline 11 ± 5.9 p = 0.16, midline 13.5 ± 6.6 vs off-midline 15 ± 11 p = 0.58, respectively) or in postoperative pain. However, incisional hernia occurred in four cases in the midline group (8%), which was significantly higher than that in the off-midline group (no cases, 0%).
CONCLUSIONS: There was no significant difference in terms of cosmetic benefit, the primary endpoint, between the two groups. In this study, only the extraction site location was compared; future studies will examine differences depending on the incisional direction, including the incidence of incisional hernia.
METHODS: Included were patients that underwent elective laparoscopic colectomy at WMUH between October 2014 and February 2017. Patients were randomly assigned to either midline incision group or off-midline incision group. Prospectively collected data included cosmetic results (patients and observer assessment scale) and complications including incidence of incisional hernia, SSI, and pain. This trial was registered with UMIN Clinical Trials (UMIN000028943).
RESULTS: Finally, 98 patients with colorectal cancer were analyzed. No significant differences were found between the two groups in patient and observer assessment scales of cosmetic results (midline 8 ± 1.1 vs off-midline 11 ± 5.9 p = 0.16, midline 13.5 ± 6.6 vs off-midline 15 ± 11 p = 0.58, respectively) or in postoperative pain. However, incisional hernia occurred in four cases in the midline group (8%), which was significantly higher than that in the off-midline group (no cases, 0%).
CONCLUSIONS: There was no significant difference in terms of cosmetic benefit, the primary endpoint, between the two groups. In this study, only the extraction site location was compared; future studies will examine differences depending on the incisional direction, including the incidence of incisional hernia.
摘要：
目的：腹腔镜结直肠手术的一个显著优点是，在摘除部位只需要一个小切口，这被认为是美容上有益的。同时,腹腔镜结肠切除术中切除标本的最佳提取部位在美容益处方面存在争议。这项随机对照试验比较了结肠癌患者腹腔镜结肠切除术中的中线和非中线摘除部位，以美容益处为主要终点。
方法：包括2014年10月至2017年2月在WMUH行择期腹腔镜结肠切除术的患者。患者被随机分配到中线切口组和非中线切口组。前瞻性收集的数据包括美容结果（患者和观察者评估量表）和并发症，包括切口疝的发生率，SSI,和痛苦。该试验已在UMIN临床试验（UMIN000028943）中注册。
结果：最后，对98例结直肠癌患者进行分析。两组患者和观察者的美容效果评估量表（中线8±1.1与中线11±5.9p=0.16，中线13.5±6.6与中线15±11p=0.58）或术后疼痛。然而,中线组4例发生切口疝（8%），明显高于非中线组(无病例，0%)。
结论：在美容益处方面没有显着差异，主要端点，两组之间。在这项研究中,仅比较了提取部位的位置；未来的研究将根据切口方向检查差异，包括切口疝的发生率。
方法：包括2014年10月至2017年2月在WMUH行择期腹腔镜结肠切除术的患者。患者被随机分配到中线切口组和非中线切口组。前瞻性收集的数据包括美容结果（患者和观察者评估量表）和并发症，包括切口疝的发生率，SSI,和痛苦。该试验已在UMIN临床试验（UMIN000028943）中注册。
结果：最后，对98例结直肠癌患者进行分析。两组患者和观察者的美容效果评估量表（中线8±1.1与中线11±5.9p=0.16，中线13.5±6.6与中线15±11p=0.58）或术后疼痛。然而,中线组4例发生切口疝（8%），明显高于非中线组(无病例，0%)。
结论：在美容益处方面没有显着差异，主要端点，两组之间。在这项研究中,仅比较了提取部位的位置；未来的研究将根据切口方向检查差异，包括切口疝的发生率。
