腹腔镜辅助与开放手术治疗直肠癌的前瞻性随机对照研究

Laparoscopic-assisted Versus Open Radical Resection for Rectal Cancer: a Prospective Randomized Controlled Trial

目的：探讨腹腔镜辅助手术治疗直肠癌的临床疗效。方法将我科2009年7月～2012年12月连续收治的176例直肠癌按纳入与剔除标准随机分为腹腔镜组和开腹组，各57例，比较2组围手术期资料和随访结果。结果腹腔镜组手术时间（165．1±23．9）min，明显长于开腹组（152．2±21．6）min（t＝3．011，P＝0．003）；术中出血量（128．8±60．2）ml，显著少于开腹组（178．1±58．2）ml（t＝-4．426，P＝0．000）；术后肠功能恢复时间（2．7±0．7）d，显著短于开腹组（3．5±0．7）d （t＝-6．074，P＝0．000）。腹腔镜组上、中、下段肿瘤下切缘距离分别为（5．2±0．7）、（3．6±0．5）、（2．6±0．5）cm，开腹组分别为（5．3±0．6）、（3．6±0．5）、（2．4±0．4） cm，2组比较无统计学差异（ t＝-0．441，P＝0．662；t＝0．000，P＝1．000；t＝1．554， P＝0．127）。腹腔镜组淋巴结清扫数目（12．4±3．7）枚，与开腹组（13．2±3．5）枚无统计学差异（t＝-1．181，P＝0．240）。腹腔镜组留置尿管时间（4．3±1．2）d，显著短于开腹组（5．1±1．3）d（t＝-3．398，P＝0．000）。腹腔镜组术后吻合口漏发生率5.4％（3/56）与开腹组3．5％（2/57）无统计学差异（χ2＝0．000，P＝0．984）；腹腔镜组术后腹腔出血发生率0，与开腹组1．8％（1/57）无统计学差异（Fisher’s检验，P＝1．000）；腹腔镜组术后排尿障碍发生率1．8％（1/56）与开腹组5．3％（3/57）无统计学差异（χ2＝0．241，P＝0．623）；腹腔镜组术后切口感染发生率7．1％（4/56）与开腹组3．5％（2/57）无统计学差异（χ2＝0.159， P＝0．659）。2组局部复发率分别为5．7％（3/53）和9．8％（5/51），无统计学差异（χ2＝0．180，P＝0．671）；远处转移率分别为13．2％（7/53）和19．6％（10/51），无统计学差异（χ2＝0．779，P＝0．378）；2组生存率无统计学差异（log-rank检验，χ2＝0．183， P＝0．669）。结论腹腔镜辅助下治疗直肠癌安全可行，疗效确切，在术后恢复上明显优于开腹手术。

Objective To evaluate the clinical outcomes of laparoscopic-assisted radical resection for rectal cancer . Methods From July 2009 to December 2013, 114 consecutive patients with rectal cancer were randomly assigned to either laparoscopic surgery group （ n =57 ） or open surgery group （ n =57 ） .General data , peri-operative parameters , recurrence and metastasis were compared between the two groups . Results The mean operation time in the laparoscopic group was longer than that in the open surgery group [（165.1 ±23.9） min vs.（152.2 ±21.6） min, t=3.011, P=0.003].The blood loss in the laparoscopic group was significantly less than that in the open group [（128.8 ±60.2） ml vs.（178.1 ±58.2） ml, t=-4.426, P=0.000].The post-operative bowel function recovery time was significant shorter in the laparoscopic group than that in the open group [（2.7 ±0.7） d vs.（3.5 ±0.7） d , t=-6.074, P=0.000].The resection ranges in the laparoscopic group for upper , middle, and lower rectal cancer were respectively （5.2 ±0.7） cm, （3.6 ±0.5） cm, and （2.6 ±0.5） cm to the lower margin of tumor, while were respectively （5.3 ±0.6） cm, （3.6 ±0.5） cm, and （2.4 ±0.4） cm in the open group, without statistically significant differences between the two groups （t=-0.441, P=0.662; t=0.000, P=1.000; t =1.554, P=0.127, respectively）.There were no statistically significant differences between the laparoscopic and the open groups in the number of lymph nodes harvested [ （ 12.4 ± 3.7） vs.（13.2 ±3.5）, t=-1.181, P=0.240].The catheter indwelling time in the laparoscopic group was significantly shorter than that in the open group [（4.3 ±1.2） d vs.（5.1 ±1.3） d, t=-3.398, P=0.000].No significant differences were observed between the two groups in the rate of postoperative anastomotic leakage [5.4%（3/56） vs.3.5%（2/57）,χ2 =0.000, P=0.984], the incidence of intraperitoneal hemorrhage [0%（0/56） vs.1.8%（1/57）,Fisher’s test, P=1.000], the rate of urination disorder [1.8%（1/56） vs.5.3%（3/57）,χ2 =0.241, P=0.623], and the infection rate of incisional wound [7.1%（4/56） vs.3.5%（2/57）,χ2 =0.159, P=0.659].During the follow-up period, the local recurrence rate [5.7%（3/53） vs.9.8% （5/51）,χ2 =0.180, P=0.671] and the rate of distant metastasis [13.2% （7/53） vs.19.6% （10/51）, χ2 =0.779, P=0.378] had no significant differences between the two groups .The survival rate was similar between the two groups （χ2 =0.183, P =0.669）. Conclusion Laparoscopic-assisted radical resection for rectal cancer is safe and feasible , with more definite short-term outcomes and better postoperative recovery than traditional surgery .