摘要
目的探讨直肠癌保肛术后吻合口漏的影响因素，分析吻合口漏对患者预后的影响。方法采用回顾性病例对照研究方法。收集2000年1月至2012年10月福建医科大学附属协和医院收治931例行直肠癌保肛术患者的临床资料。cT3—4期和（或）N1～2期患者行新辅助放化疗，新辅助放化疗结束后6～8周手术治疗。患者遵循全直肠系膜切除原则行直肠癌保肛手术，部分患者行预防性肠造口术。观察指标：（1）手术情况。（2）术后吻合口漏情况。（3）影响吻合口漏发生的危险因素分析。（4）随访情况及预后分析。采用电话、信件、门诊相结合的方式进行随访，术后2年内每3个月随访1次，术后第3年每半年随访1次，术后第4年后每年随访1次。随访内容包括体格检查、血CEA、CA19—9、肺部CT、腹部MRI及肠镜等检查以及术后辅助化疗情况。随访终点为发现肿瘤复发转移或患者死亡，随访时间截至2015年8月31日。正态分布的计量资料采用x^-±s表示，组间比较采用独立样本t检验；偏态分布的计量资料以肘（范围）表示，组间比较采用Mann—WhitneyU检验。计数资料比较采用x^2检验或Fisher确切概率法。单因素分析采用方差分析最小显著性差异（LSD）方法。多因素分析采用Logistic回归模型。采用Kaplan—Meier法绘制生存曲线，Log—rank检验进行生存分析。失访患者作为删失值纳入生存分析。结果（1）手术情况：931例患者均行直肠癌保肛手术，其中行直肠癌低位前切除术422例（开腹手术66例、腹腔镜手术356例），行直肠癌超低位前切除术286例（开腹手术79例、腹腔镜手术207例），行直肠癌前切除术223例（开腹手术105例、腹腔镜手术118例）。931例患者中，78例行腹腔镜辅助括约肌间切除术。307例患者行预防性肠造口术，624例未行预防性肠造口术。患者的手术时间为（183±52）min、术中出血量为（112±30）mL。（2）术后吻合口漏情况：术后42例患者发生吻合口漏，吻合口漏于术后7d（2～14d）确诊，行腹腔镜手术患者吻合口漏的发生时间为术后4d（2—6d），早于行开腹手术患者的10d（7～14d），两者比较，差异有统计学意义（Z=0．034，P〈0．05）。行预防性肠造口术患者术后吻合口漏发生率为2．61％（8／307），未行预防性肠造口术的患者吻合口漏发生率为5．45％（34／624），两者比较，差异有统计学意义（x^2=3．860，P〈0．05）。吻合口漏严重程度：2例A级患者，未行特殊处理自行好转；19例B级患者，经对症支持治疗后好转；21例C级患者，其中1例行单纯漏口修补术，1例行Hartmann术，2例行腹腔冲洗引流，2例行漏口修补联合肠造口术，15例行肠造口术。（3）影响吻合口漏发生的危险因素分析：单因素分析结果显示：直肠癌保肛术后发生吻合口漏与患者年龄、术前Alb、肿瘤下缘距肛缘距离、新辅助放化疗、预防性肠造口有关（x^2=4．018，3．969，5．767，6．585，3．860，P〈0．05）。多因素分析结果显示：肿瘤下缘距肛缘距离45cnl、新辅助放化疗是直肠癌患者保肛术后发生吻合口漏的独立危险因素（OR=1．264，2．459，95％可信区间：1．149～1．457，1．181～5．123，P〈0．05）；而预防性肠造口是直肠癌患者保肛术后吻合口漏的保护因素（OR=0．407，95％可信区间：0．182～0．912，P〈0．05）。（4）随访情况及预后分析：833例患者术后获得随访，其中721例完成术后辅助化疗；98例患者失访，其中发生吻合口漏5例，未发生吻合口漏93例，两者比较，差异无统计学意义（P〉0．05）。患者中位随访时间为84个月（34～179个月）。42例术后发生吻合口漏患者的5年无瘤生存率、肿瘤远处转移率，肿瘤局部复发率分别为75．7％、21．4％和7．1％，889例术后未发生吻合口漏患者分别为79．6％、15．2％和5．1％，两者比较，差异均无统计学意义（x^2=0．504，0．447，0．076，P〉0．05）。结论肿瘤下缘距肛缘45cm和新辅助放化疗是直肠癌保肛术后发生吻合口漏的独立危险因素，选择性行预防性肠造口术是预防吻合口漏的有效措施。吻合口漏不影响患者远期无瘤生存率、肿瘤远处转移率以及局部复发率。
Objective To investigate the influencing factors of anastomotic leakage after anus-preserving operation for rectal cancer and analyze the prognosis of patients. Methods The retrospective case-control study was adopted. The clinical data of 931 patients with rectal cancer who underwent anus-preserving operation at the Union Hospital of Fujian Medical University between January 2000 and October 2012 were collected. Patients in stage cT3-4 and （or） N1-2 underwent surgery within 6-8 weeks after neoadjuvant chemoradiation. Patients underwent anus-preserving operation for rectal cancer based on the principle of total mesorectal excision, and partial patients underwent enterostomy. Observation indicators included： （1） surgical situation, （2） post- operative anastomotic leakage, （3） risk factors analysis affecting anastomotic leakage, （4） follow-up and prognostic analysis. Follow-up using telephone interview, correspondence and outpatient examination was conducted once every 3 months within postoperative 2 years, once every 6 months at postoperative 3 years and once every 1 year at postoperative 4 years up to August 31, 2015. Follow-up included the physical examination, serum carcinoembryonic antigen （CEA）, CA19-9, lung computed tomography （CT）, abdominal magnetic resonance imaging （ MRI ） , colonoscopy and postoperative adjuvant chemotherapy, and the end of follow-up was tumor recurrence and metastasis or death. Measurement data with normal distribution was presented asx ＋ s, and comparisons between groups were evaluated with an independent sample t test . Measurement data with skewed distribution were presented as M （range） , and comparisons between groups were evaluated with the Mann-Whitney U test. Count data were analyzed using the chi-square test or Fisher exact probability. The univariate analysis and nmhivariate analysis were respectively done using the least significant difference （LSD） and Logistic regression model. The survival curve was drawn by Kaplan-Meier method, and the survival rate was analyzed using the Log- rank test. Results （1） Surgical situation： of 931 patients undergoing anus-preserving operation for rectal cancer, 422 underwent low anterior resection of rectal cancer （ open surgery in 66 patients and laparoscopic surgery in 356 patients ） , 286 underwent uhralow anterior resection of rectal cancer （open surgery in 79 patients and laparoscopic surgery in 207 patients）, 223 underwent anterior resection of rectal cancer （ open surgery in 105 patients and laparoscopic surgery in 118 patients）. Among 931 patients, 78 underwent laparoscopy-assisted intersphincteric resection. Among 931 patients, 307 received preventive enterostomy, 624 unreceived preventive enterostomy. Operation time and volume of intraoperative blood loss were （183 ± 52）minutes and （112 ± 30）mL. （2） Postoperative anastomotic leakage situation： anastomotic leakage that was confirmed in 42 patients was occurred at postoperative 7 days （range, 2-14 days）, anastomotic leakage in patients with laparoscopic surgery and open surgery was respectively occmxed at postoperative 4 days （range, 2-6days） and 10 days （range, 7- 14 days） , with a statistically significant difference （ Z = 0. 034, P 〈 0.05 ）. Incidences of anastomotic leakage in patients with and without preventive enterostomy were respectively 2.61% （8/307） and 5.45 % （34/624）, with a statistically significant difference x^2 = 3. 860, P 〈 0. 05 ）. Severity of anastomotic leakage ： 2 patients in grade A were improved by themselves without special treatment, 19 in grade B were improved after symptomatic treatment, and 21 in grade C, including 1 undergoing simplex leaking stoma repair, 1 undergoing Hartmenn, 2 undergoing peritoneal lavage and drainage, 2 undergoing leaking stoma repair combined with enterostomy and 15 undergoing enterostomy. （3） Risk factors analysis affecting anastomotic leakage： univariate analysis showed that anastonmtic leakage after anus-preserving operation for rectal cancer was associated with age, preoperative serum albumin （Alb）, distance from the distal margin of tumor to anal verge, neoadjuvant chemoradiation and preventive enterostomy （x^2= 4. 018, 3. 969, 5. 767, 6. 585, 3. 860, P 〈 0. 05）. Multivariate analysis showed that distance from the distal margin of tumor to anal verge≤5 cm and neoadjuvant ehemoradiation were independent risk factors affecting anastomotic leakage after anus-preserving operation for rectal cancer [ OR = 1. 264, 2. 459, 95% confidence interval （CI） ： 1. 149-1. 457, 1. 181-5. 123, P 〈0.05 ] , and preventive enterostomy was a protective factor for anastomotic leakage after anus-preserving operation for rectal cancer （OR =0. 407, 95% （3： O. 182- 0. 912, P 〈 0.05）. （4） Follow-up situation and prognostic analysis： eight hundred and thirty-three patients were followed up with a median time of 84 months （range, 34-179 months）, of whom 721 received postoperative adjuvant chemotherapy, and 98 was loss to follow-up, including 5 with anastomotic leakage and 93 without anastomotic leakage, showing no statistically significant difference （ P 〉 0.05 ）. The 5-year tumor-free survival rate, distant metastasis rate and local recurrent rate were 75.7%, 21.4% , 7. 1% in patients with anastomotic leakage and 79.6%, 15.2%, 5.1% in patients without anastomotic leakage, respectively, with no statistically significant difference x^22 = 0. 504, 0. 447, 0. 076, P 〉 0.05 ）. Conclusions The distance from distal margin of tumor to anal verge ≤5 cm and neoadjuvant chemoradiation are independent risk factors affecting anastomotic leakage after anus-preserving operation for rectal cancer, and selective preventive enterostomy is an effective measure of preventing anastomotic leakage. Anastomotic leakage cannot affect the long-term tumor-fi＇ee survival rate, distant metastasis rate and local recurrent rate.
出处
《中华消化外科杂志》
CAS
CSCD
北大核心
2016年第8期795-801,共7页
Chinese Journal of Digestive Surgery
基金
国家临床重点专科建设资助项目[卫办医政函（2012）649号]
关键词
直肠肿瘤
吻合口漏
多因素分析
Rectal neoplasms
Anastomotic leakage
Muhivariate analysis
