溶脂法研究直肠癌在直肠远端系膜内的播散

目的 研究直肠癌在直肠远端系膜内播散的规律.方法 收集直肠癌根治手术标本60例,整体平铺用溶脂法处理后,绘制淋巴结分布图,逐个定位、计数淋巴结及癌转移结节,显微镜下观察其转移规律.结果 直肠癌在直肠远端系膜的播散方式主要为淋巴结转移和癌转移结节形成,远端系膜总播散率为13%（8/60）,淋巴结播散率为10%（6/60）,癌结节播散率为7%（4/60）,播散最远距离为4.5 cm.肿瘤大体类型、组织学类型和浸润深度是影响直肠癌远端系膜淋巴结播散的因素.肿瘤部位及Dukes分期是影响直肠癌远端系膜癌转移结节播散的因素.结论 利用溶脂法能全面客观地观察直肠远端系膜内癌组织的播散规律.直肠癌手术远端系膜切除距肿瘤下缘不应少于4.5 cm或行全系膜切除.     

A new technique to achieve sufficient mesorectal excision in upper rectal cancer

BACKGROUND: Appropriate partial mesorectal excision (PME) is extremely important for prevention of local recurrence even in upper rectal cancer. However, it is not always easy to conduct PME in the narrow pelvic cavity. We devised a new surgical technique that involves a rectal transection followed by PME. METHODS: After rectal mobilization in the layer targeted for total mesorectal excision, only the rectal wall was bluntly dissected at an appropriate distance from the tumor. Initial transection of the rectum allows drawing the rectum toward the anal side so that the mesorectum can be confirmed with a good visual field. Excision of the mesorectum was easy, and it could be resected in a short time. RESULTS: This technique was conducted on seven patients with upper rectal cancer and on four patients with rectosigmoid cancer. Separation of the rectal wall was comparatively easy, and we had no incidence of wall injury. The average distance from the rectal stump to the distal mesorectum in the freshly resected specimen was 15 mm, indicating satisfactory PME. CONCLUSIONS:This easily performed method is a promising procedure for achieving sufficient PME in upper rectal cancer.     

Clinical significance of macroscopic completeness of mesorectal resection in rectal cancer

Aim Local recurrence after resection of rectal cancer is usually regarded as being due to a ‘failure’ of surgery. The completeness of resection of the mesorectum has been proposed as an indicator of the ‘quality’ of the resection. We determined the prognostic value of macroscopic evaluation of rectal cancer resection specimens and the circumferential resection margin (CRM) after curative surgery. Method From 1999 to 2006, the macroscopic quality of the mesorectum and the CRM were prospectively assessed in 127 patients who underwent rectal cancer resection with curative intent (R0+R1). Chemoradiotherapy was administered for 61 tumours staged as locally advanced tumours (T3, T4 and N+). Univariate analysis of time to local recurrence and cancer‐free survival were tested (Kaplan–Meier) and multivariate analysis calculated with a Cox regression model. Results The mesorectum was incomplete in 34 (26.8%) patients. At a median follow up of 34 months (range, 9–96 months), in the group with an adequate mesorectal excision, the cumulative risk of local recurrence at 5 years was 10%. This was 25% if the mesorectum was incomplete (P < 0.01). Five‐year cancer‐free survival was 65% if the mesorectal excision was adequate and 47% if it was not (P < 0.05). Multivariate analysis identified T status, the CRM and the mesorectal score as independent factors for local recurrence, and T and N status and the mesorectal score as independent factors for disease‐free survival. Conclusion The outcome of surgical treatment of rectal cancer is related to the completeness of mesorectal excision. It is a more discriminative prognostic factor than the classic tumour–node–metastasis (TNM) system.     

Local recurrence and survival after laparoscopic mesorectal resection for rectal adenocarcinoma

Background: Laparoscopic resection for rectal cancer is controversial. Actuarial survival and local recurrence rates have not been determined. Methods: A prospective database containing 80 consecutive unselected laparoscopic resections of rectal cancers performed between November 1991 and 1999 was reviewed. Local recurrence was defined as any detectable local disease at follow-up assessment occurring either alone or in conjunction with generalized recurrence. The tumor node metastases (TNM) classification for colorectal cancers and the Kaplan-Meier method were used to determine staging and survival curves. The mesorectal excision technique was used during surgery. Results: The median follow-up period was 31 months for patients with stages I, II, and III cancer, and 15.5 months for patients with stage IV cancer. The overall 5-year survival rate was 65.1% for all cancer stages and 72.1% for stages I, II, and III cancer. No trocar-site recurrence was observed. The overall local recurrence rate was 3.75% (3/80) for all cancer stages, and 4.3% (3/70) for stages I, II, and III cancer. Conclusions: The survival and local recurrence rates for patients with rectal cancer treated by laparoscopic mesorectal excision do not differ negatively from those in the literature for open mesorectal excision. Further validation is needed.     

侧方淋巴结清扫对进展期低位直肠癌预后的影响

目的 应用治疗指数(therapeutic index,TX)(TX=肿瘤相关5年生存率×区域淋巴结转移的概率)评估侧方淋巴结清扣对于改善进展期低位直肠癌预后的价值.方法 回顾性分析直肠癌行根治性切除+全直肠系膜切除+侧方淋巴结清扫的96例进展期低位直肠癌患者的临床资料.结果 进展期低位直肠癌直肠系膜淋巴结、直肠上动脉旁淋巴结、肠系膜下动脉旁淋巴结和侧方淋巴结转移率分别为21%(20/96),13%(12/96),10%(10/96)和15%(14/96).检出直肠系膜淋巴结、直肠上动脉旁淋巴结、肠系膜下动脉旁淋巴结和侧方淋巴结转移阳性的进展期低位直肠癌患者5年生存率分别为35%,25%,20%和36%.TX:清扫直肠系膜淋巴结和侧方淋巴结的TX分别为7.4和5.4,明显高于清扫直肠上动脉和肠系膜下动脉旁淋巴结的3.3和2.0.侧方淋巴结转移阳性者术后局部复发率为64%(9/14),TX明显高于侧方淋巴结转移阴性者的11%(9/82)(x2=22.308/P=0.000).Kaplan-Meier生存分析显示,侧方淋巴结转移阳性患者平均生存期为(38.0±6.7)个月(95%置信区间:24.8～51.2个月),明显短于侧方淋巴结转移阴性的(80.9±2.1)个月(95%置信区间:76.7～85.1个月),两者差异有统计学意义. 结论侧方淋巴结清扫可降低进展期低位直肠癌根治性切除术后局部复发率以及改善预后.除全直肠系膜切除外,进展期低位直肠癌术中还应进行侧方淋巴结清扫.     

Results of extrafascial excision and conventional surgery for rectal cancer at Auckland Hospital

BACKGROUND: Recent studies have suggested that local recurrence rates following rectal cancer surgery are reduced if the mesorectum is removed intact within its fascia propria. The present study aims to compare the outcomes of conventional surgery for rectal cancer and surgery in which the rectum and mesorectum are removed by the technique of extrafascial excision (EFE). METHODS: All patients undergoing surgery for rectal cancer at Auckland Hospital from 1980 to 1996 were identified. Demographic, tumour, operation, outcome, survival and follow-up data were obtained from patient charts, New Zealand (NZ) Death Registry, death certificates and the NZ Electoral Roll. Complication rates, recurrence rates, overall and cancer-free survival and treatment costs were calculated for each group. RESULTS: A total of 262 patients had curative surgery (138 had conventional surgery, 124 had EFE). The groups were similar with respect to age, sex, operation performed and Dukes' stage. There was no difference in complication rates between the groups. Mean follow-up was 7 years in survivors. Twenty-nine conventional-surgery (21%) and eight EFE (6%) patients developed local pelvic recurrence. The 5-year actuarial local recurrence rates were 30% and 10%, respectively (P = 0.0006). The 5-year overall survival was 54% for conventional surgery and 60% for EFE (P = 0.23). The 5-year cancer-free survival was 63% for conventional surgery and 74% for EFE (P = 0.02). Average initial costs were NZ$15,717 and NZ$15,158 for conventional surgery and EFE, respectively. The average cost of local recurrence was an additional NZ$10,471. CONCLUSIONS: The present study adds further support to the growing evidence that excision of the mesorectum within an intact fascial envelope reduces local recurrence rates after surgery for rectal cancer. There appears to be an associated improvement in cancer-free survival. Complication rates and cost were not increased in the patients having EFE.     

腹腔镜下直肠癌全直肠系膜切除术

目的 探讨腹腔镜下行直肠癌全直肠系膜切除根治术的临床效果。方法 对38例直肠腺癌患者采用腹腔镜下联合应用超声刀循盆筋膜壁层和脏层的间隙行锐性游离全直肠系膜,切除一个不间断的直肠整体标本,并对全组病例随访2年余。结果 38例患者手术顺利,无中转开腹,术后排便、排气时间平均为32h,术后平均住院天数为7．5d。术后随访至今,38例患者均无腹部穿刺口种植,其中2例出现局部复发(1例伴肝转移)。38例患者均无排尿困难,6例患者有性功能减退。结论 腹腔镜下行直肠癌全直肠系膜切除术手术既能有效降低术后局部复发率和保护盆腔自主神经功能,又具有微创优点,值得临床推广。     

Rectal carcinoma. Optimizing therapy by partial or total mesorectum removal]

The role of total mesorectal excision for rectal cancer treatment is one of the most exciting findings in surgical oncology of the recent years. The patient's prognosis largely depends on the surgical quality of rectal resection. The excision of the cancer bearing rectum has to follow very precisely along the mesorectal fascia by sharp dissection without damaging the mesorectum itself. This technique reduces the local recurrence rate to below 10% and allows long-term survival in two thirds of all patients. Rectal cancers of the middle and lower third of the rectum need to be treated by total mesorectal excision down to the muscular pelvic floor, the ones of the upper third and the sigmoideo-rectal junction are appropriately treated by partial mesorectal excision down to 5 cm below the tumor. No additional survival benefit may be expected when pelvic lymphadenectomy has been performed. The direct tumor spread along the bowel wall and the lymphatic tumor spread in a caudal direction are uncommon and late findings in rectal cancer disease. Low and ultralow rectal carcinomas may therefore be treated by a sphincter preserving procedure respecting a safety margin of at least 1 to 2 cm. Thus, continence preserving surgery may be performed in over 80% of patients suffering from rectal cancer without compromising long-term outcome.     

Distal dissection in total mesorectal excision,and preoperative chemoradiotherapy and lateral lymph node dissection for rectal cancer

The local recurrence rate after total mesorectal excision (TME) appears to be markedly lower than that after conventional operations. We reviewed all relevant articles identified from the MEDLINE databases and clarified the rationale for TME. It is clear that distal intramural spread is rare. Even when present, such spread is not likely to extend beyond 2 cm. Data with attention to mesorectal cancer deposits suggest that mesorectal clearance of at least 4–5 cm distal to the tumor should be sufficient. TME should be performed for most tumors of the mid- and lower rectum. This does not mean that the gut tube needs to be divided at the same level in every case. Dissection of the distal mesorectum off the gut tube can be performed, so the distal line of division of the bowel wall can be made at a minimum of 2 cm below the tumor if such a maneuver would ensure that the sphincters are preserved. In cases with cancer in the upper third of the rectum, the mesorectum and gut tube can safely be divided 5 cm below the tumor without jeopardizing the recurrence rates. Our findings indicate that TME is an essential treatment approach for rectal cancer, and lateral lymph node dissection and preoperative chemoradiotherapy are additional therapies that should be considered for advanced rectal cancer.     

直肠癌大组织切片系膜九分区法病理学研究

目的　探索直肠癌全直肠系膜切除术 (TME)的必要性和选择性全直肠系膜切除术(STME)的最佳切除范围。方法　以 31例直肠癌TME手术标本为对象 ,纵向由远及近以 5mm的间距连续取材 ,常规固定包埋 ,大组织切片机以 2 .5cm的间隔连续切片 ,HE染色 ,光学显微镜观察结果。将直肠系膜等分为内、中、外三个带 ,每带按左、右、后三个方向分为三个区 ,直肠癌在直肠系膜内的转移灶分别定位于上述九个区。结果　直肠系膜外带内癌转移 1 4例 (4 5 .2 % ) ,全部为低位直肠癌 ;远端直肠系膜 (DMR)内癌转移 2例 (6 .5 % ) ,均在原发灶下缘以远 3.0cm以内 ;环周切缘癌浸润 2例 (6 .5 % )。结论　低位直肠癌根治手术时 ,完整地切除直肠系膜非常必要 ;远端直肠系膜的切除应达到肿瘤下缘以远 4cm。     

中低位直肠癌系膜浸润程度的临床研究

目的探讨中低位直肠癌直肠系膜浸润程度与临床病理特征及预后的关系。方法采用大组织切片技术,测量行全直肠系膜切除术的49例中低位直肠癌标本的肿瘤浸润深度及直肠系膜厚度,计算直肠系膜浸润程度;并分析其临床病理特征和随访结果。结果本组中低位直肠癌术后局部复发率为12．2％（6／49）,远处转移率为26．5％（13／49）。直肠癌直肠系膜浸润程度Ⅰ度20例（40．8％）,Ⅱ度13例（26．5％）,Ⅲ度16例（32．7％）,Ⅰ、Ⅱ、Ⅲ度者术后局部复发率分别为0、7．7％和31．3％（X^2=7．357,P=0．015）;远处转移率分别为10％、23．1％和50％（X^2=7．405,P=0．025）;5年生存率则分别为90．9％、69．2％和28．6％（p=0．013）。直肠系膜浸润程度与肿瘤直径（X^2=6．849,P=0．033）、T分期（X^2=34．845,P=0．000）、N分期（X^2=17．266,P=0．002）有关。结论直肠系膜浸润程度是影响直肠癌预后的重要因素。     

Radiological findings do not support lateral residual tumour as a major cause of local recurrence of rectal cancer

BACKGROUND: The aim of this study was to determine the sites of local recurrence following radical (R0) total mesorectal excision (TME) for rectal cancer in an effort to elucidate the reasons for recurrence. METHODS: Thirty-seven patients with recurrence following curative resection for rectal cancer were identified from a population of 880 patients operated on by surgeons trained in the TME procedure. Two radiologists independently examined 33 available computed tomograms and magnetic resonance images taken when the recurrence was detected. RESULTS: Twenty-nine of the 33 recurrences were found in the lower two-thirds of the pelvis. Two recurrent tumours appeared to originate from lateral pelvic lymph nodes. Evidence of residual mesorectal fat was identified in 15 patients. Fourteen of the recurrent tumours originated from primary tumours in the upper rectum; all of these tumours recurred at the anastomosis and 12 of the 14 patients had evidence of residual mesorectal fat. CONCLUSION: Lateral pelvic lymph node metastases are not a major cause of local recurrence after TME. Partial mesorectal excision may be associated with an increased risk of local recurrence from tumours in the upper rectum.     

Recurrence and survival after surgical management of rectal cancer.

BACKGROUND: Reported local recurrence rates for rectal cancer are significantly reduced using a combination of superior surgical technique, in the form of total mesorectal excision, and routine radiotherapy. In an attempt to determine the effectiveness of current local management strategies, a review of Vancouver Island Cancer Centre patients with rectal cancer was performed and the overall local recurrence rate was identified. METHODS: We retrospectively reviewed the charts of 272 rectal cancer patients from 1988 to 1998. Two hundred and twenty-nine patients met inclusion criteria. Analysis of patient factors included age, gender, type of surgery, and adjuvant therapy. Tumors were assessed for level, stage, and grade. Local recurrence and distant metastases were also documented. Variables influencing local recurrence in this group were identified and disease-free and actuarial survival determined. RESULTS: Of 229 patients analyzed, 12.7% (29) had local recurrences. Variables influencing local recurrence were number of positive lymph nodes, vascular invasion, and neural invasion. There was no significant difference in local recurrence between patients having anterior resection and those having abdominoperineal resection. None of the patients who received preoperative radiotherapy had a local recurrence. Actuarial disease-free survival was 87% at 5 years. CONCLUSIONS: Limiting local recurrence is one of the most important goals in the treatment of rectal cancer. It is essential to identify those patients with "high risk" tumors as identified by endorectal ultrasound or pathologic features. These patients comprise the group most likely to benefit from a routine mesorectal excision combined with adjuvant radiotherapy.     

Anterior resection for rectal cancer with mesorectal excision: a prospective evaluation of 622 patients

OBJECTIVE: This study aims to review the operative results and oncological outcomes of anterior resection for rectal and rectosigmoid cancer. Comparison was made between patients with total mesorectal excision (TME) for mid and distal cancer and partial mesorectal excision (PME) for proximal cancer, when a 4- to 5-cm mesorectal margin could be achieved. Risk factors for local recurrence and survival were also analyzed. SUMMARY BACKGROUND DATA: Anterior resection has become the preferred treatment option rectal cancer. TME with sharp dissection has been shown to be associated with a low local recurrence rate. Controversies still exist as to the need for TME in more proximal tumor. METHODS: Resection of primary rectal and rectosigmoid cancer was performed in 786 patients from August 1993 to July 2002. Of these, 622 patients (395 men and 227 women; median age, 67 years) underwent anterior resection. The technique of perimesorectal dissection was used. Patients with mid and distal rectal cancer were treated with TME while PME was performed for those with more proximal tumors. Prospective data on the postoperative results and oncological outcomes were reviewed. Risk factors for anastomotic leakage, local recurrence, and survival of the patients were analyzed with univariate and multivariate analysis. RESULTS: The median level of the tumor was 8 cm from the anal verge (range, 2.5-20 cm) and curative resection was performed in 563 patients (90.5%). TME was performed in 396 patients (63.7%). Significantly longer median operating time, more blood loss, and a longer hospital stay were found in patients with TME. The overall operative mortality and morbidity rates were 1.8% and 32.6%, respectively, and there were no significant differences between those of TME and PME. Anastomotic leak occurred in 8.1% and 1.3% of patients with TME and PME, respectively (P < 0.001). Independent factors for a higher anastomotic leakage rate were TME, the male gender, the absence of stoma, and the increased blood loss. The 5-year actuarial local recurrence rate was 9.7%. The advanced stage of the disease and the performance of coloanal anastomosis were independent factors for increased local recurrence. The 5-year cancer-specific survival was 74.5%. The independent factors for poor survival were the advanced stage of the disease and the presence of lymphovascular and perineural invasion. CONCLUSIONS: Anterior resection with mesorectal excision is a safe option and can be performed in the majority of patients with rectal cancer. The local recurrence rate was 9.7% and the cancer-specific survival was 74.5%. When the tumor requires a TME, this procedure is more complex and has a higher leakage rate than in those higher tumors where PME provides adequate mesorectal clearance. By performing TME in patients with mid and distal rectal cancer, the local control and survival of these patients are similar to those of patients with proximal cancers where adequate clearance can be achieved by PME.     

应用流式细胞技术及病理检测对直肠癌手术切除范围的再探讨

目的探讨直肠癌根治术合理的手术范围。方法应用病理检测和流式细胞技术,对30例直肠癌全直肠系膜切除术标本进行分析,观察直肠癌组织和癌远端3cm和5cm、正常肠管组织和癌旁3cm和5cm直肠系膜及正常结肠系膜组织的DNA倍体、DNA指数（DI）、增殖指数（PI）和增殖期细胞百分比（SPF）值的变化,并与病理检测相对照。结果病理检测结果显示：直肠癌远端3cm和5cm肠管中均未检测到癌浸润．而癌旁3cm和5cm直肠系膜癌转移率分别为26．7％和6．7％。流式细胞技术检测结果显示：癌组织的DI、P1和SPF值显著高于癌远端3cm和5cm及正常肠管组织,癌远端3cm肠管组织也显著高于癌远端5cm及正常肠管组织,而癌远端5cm肠管与正常肠管比较,差异无统计学意义（P〉0．05）。癌组织细胞异倍体率与癌远端3cm肠管比较,差异无统计学意义（P〉0．05）;而显著高于癌远端5cm及正常肠管组织。癌组织的DI和异倍体率与癌旁3cm和5cm直肠系膜组织相比,差异无统计学意义．但显著高于正常系膜,而癌旁3cm和5cm直肠系膜组织的DI和异倍体率亦显著高于正常系膜。癌组织P1和SPF则显著高于癌旁3cm和5cm及正常系膜。结论病理学分析结果显示．直肠癌远端3cm肠管组织为安全组织;而流式细胞学分析结果显示．直肠癌远端3cm肠管组织和癌旁5cm直肠系膜为不安全组织;手术切除范围应达癌远端系膜5cm以上。     

全直肠系膜切除术安全远切端距离的临床研究

目的 探讨全直肠系膜切除术(TME)原则下直肠癌低位前切除术的安全远切端距离.方法 回顾性分析5年间412例TME原则下直肠癌低位前切除术患者的临床资料,比较不同远切端距离(DML)分组间并发症发生率、远处转移率、复发率和生存率的差异.结果 DML＜2 cm组,2～3 cm(含2 cm和3 cm)组,＞3 cm组患者术后并发症发生率和远处转移率差异均无统计学意义(P=0.494和P=0.906).DML＜2 cm组局部复发率(19.30%)显著高于DML2～3 cm组(8.37%,P=0.015)和DML＞3 cm组(7.69%,P=0.029),后两组局部复发率差异无统计学意义(P=0.833).DML＜2 cm组,2～3 cm组,＞3 cm组3年生存率依次为69.4%,86.5%,89.9%;5年生存率依次为63.0%,70.7%,71.1%.DML＜2 cm组总生存率显著低于2～3 cm组和＞3 cm组,差异有统计学意义(P=0.030和P=0.040).DML2～3 cm组和＞3 cm组总生存率之间差异无统计学意义(P=0.707).结论 遵循TME原则下的直肠癌低位前切除术,＜2 cm的远切端距离是不足够的;对于分化较好的直肠腺癌,≥2 cm是可接受的远切端安全距离.     

全直肠系膜切除术在中低位直肠癌治疗的应用

目的:探讨全直肠系膜切除术在中、低位直肠癌治疗的应用。方法:回顾总结69例行全直肠系膜切除术的中、低位直肠癌病例,分析其疗效、局部复发、并发并发症的处理及预防。结果:围手术期死亡率1.45％(1/69);5年生存率67.6％(25/37);2年局部复发率5.8％(4/69);发生吻合口瘘和吻合口狭窄分别为6例(8.7％)和5例(7.25％)。结论:全直肠系膜切除术可有效降低局部复发率和提高生存率,因而是治疗中、低位直肠癌的理想手术。     

Comparative outcome between chemoradiotherapy and lateral pelvic lymph node dissection following total mesorectal excision in rectal cancer

OBJECTIVE: To evaluate comparative outcome between adjuvant postoperative chemoradiotherapy (postoperative CRT) and lateral pelvic lymph node dissection (LPLD) following total mesorectal excision (TME) in rectal cancer patients. BACKGROUND: Although TME results in lower rate of locoregional recurrence compared with conventional surgery, these 2 treatment modalities following TME have not adequately been appraised until the present trend of preoperative chemoradiotherapy. PATIENTS AND METHODS: Between 1995 and 2000, patients with stage II and III rectal cancer underwent TME plus postoperative CRT (n = 309) or LPLD (n = 176). Patients in the postoperative CRT group received 8 cycles of 5-fluorouracil plus leucovorin and 45 Gy pelvic radiotherapy. Patients in the LPLD group underwent lateral lymph node dissection outside the pelvic plexus. RESULTS: The 5-year overall and disease-free survival rates were 78.3% and 67.3% in the postoperative CRT group, respectively, and 73.9% and 68.6% in the LPLD group, respectively, without significant differences between these groups. Patients in the LPLD group with stage III lower rectal cancer had a locoregional recurrence rate 2.2-fold greater than those in the postoperative CRT group (16.7% vs. 7.5%, P = 0.044). Multivariate analysis showed that APR and advanced T-category (T4) were significantly associated with locoregional recurrence, whereas lymph node metastases, high preoperative serum carcinoembryonic antigen, and APR were significantly associated with shortening of disease-free survival. CONCLUSIONS: Postoperative-CRT and LPLD following TME resulted in comparable survival rates, but the locoregional recurrence rate was higher in the LPLD group. These findings suggest that initial surgery is appropriate for rectal cancer patients who are candidates for low anterior resection without extensive local disease (T1-T3), regardless of lymph node status.     

The TME trial after a median follow-up of 6 years: increased local control but no survival benefit in irradiated patients with resectable rectal carcinoma

OBJECTIVE: To investigate the efficacy of preoperative short-term radiotherapy in patients with mobile rectal cancer undergoing total mesorectal excision (TME) surgery. SUMMARY BACKGROUND DATA: Local recurrence is a major problem in rectal cancer treatment. Preoperative short-term radiotherapy has shown to improve local control and survival in combination with conventional surgery. The TME trial investigated the value of this regimen in combination with total mesorectal excision. Long-term results are reported after a median follow-up of 6 years. METHODS: One thousand eight hundred and sixty-one patients with resectable rectal cancer were randomized between TME preceded by 5 x 5 Gy or TME alone. No chemotherapy was allowed. There was no age limit. Surgery, radiotherapy, and pathologic examination were standardized. Primary endpoint was local control. RESULTS: Median follow-up of surviving patients was 6.1 year. Five-year local recurrence risk of patients undergoing a macroscopically complete local resection was 5.6% in case of preoperative radiotherapy compared with 10.9% in patients undergoing TME alone (P < 0.001). Overall survival at 5 years was 64.2% and 63.5%, respectively (P = 0.902). Subgroup analyses showed significant effect of radiotherapy in reducing local recurrence risk for patients with nodal involvement, for patients with lesions between 5 and 10 cm from the anal verge, and for patients with uninvolved circumferential resection margins. CONCLUSIONS: With increasing follow-up, there is a persisting overall effect of preoperative short-term radiotherapy on local control in patients with clinically resectable rectal cancer. However, there is no effect on overall survival. Since survival is mainly determined by distant metastases, efforts should be directed towards preventing systemic disease.