Participants in prospective, randomized clinical trials for resected non-small cell lung cancer have improved survival compared with nonparticipants in such trials. Laparoscopic vs open total mesorectal excision for rectal cancer: an evaluation of the mesorectum's macroscopic quality. A prospective randomized controlled trial of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer. Final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC). Laparoscopic total mesorectal excision: a consecutive series of 100 patients. Laparoscopic rectal resection with anal sphincter preservation for rectal cancer: long-term outcome. The surgeon as a prognostic factor after the introduction of total mesorectal excision in the treatment of rectal cancer. Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group. Rectal cancer surgery with or without bowel preparation: The French GRECCAR III multicenter single-blinded randomized trial.
The survival of 78 patients with resected non-small cell lung cancer entered in prospective, randomized investigational trials is compared to that of a population-based group of control patients not included in such trials. The survival of trial patients is significantly better than that of controls (P less than 0.001). This survival advantage for trial participants is most apparent among late Stage I patients, and is observed after matching for known prognostic factors (i.e., primary tumor size, nodal status, tumor histology) and after adjusting in the analysis for age, sex, and the administration of radiation therapy. Several explanations for the improved outcome for trial patients are explored, including differences in preoperative evaluation, staging, surgical technique, placebo effects, and patient motivation. These results suggest the possibility that inclusion in these controlled cancer trials may have had an inherent advantage for all participants. Next to surgical margins, yield of lymph nodes, and length of bowel resected, macroscopic completeness of mesorectal excision may serve as another quality control of total mesorectal excision (TME). In this study, the macroscopic completeness of laparoscopic TME was evaluated.
                A series of 25 patients with rectal cancer were managed laparoscopically (LTME) and included in this study. The pathologic specimens of the LTME group were prospectively examined and matched with a historical group of resection specimens from patients who had undergone open TME (OTME). The two groups were matched for gender and type of resection (low anterior or abdominoperineal resection). Special care was given to the macroscopic judgment concerning the completeness of the mesorectum.
                A three-grade scoring system showed no differences between the LTME and OTME groups.
                The current study supports the hypothesis that oncologic resection using laparoscopic TME is feasible and adequate. A prospective randomized controlled trial (RCT) of multimodal perioperative management protocol in patients undergoing elective colorectal resection for cancer.
                This study evaluates the use of a multimodal package in colorectal cancer surgery in the context of an RCT.
                Patients for elective resection for colorectal cancer were offered trial entry. Participants were stratified by sex and requirement for a total mesorectal excision and centrally randomized. Multimodal patients received intravenous fluid restriction, unrestricted oral intake with prokinetic agents, early ambulation, and fixed regimen epidural analgesia. Control patients received intravenous fluids to prevent oliguria, restricted oral intake until return of bowel motility, and weaning regimen epidural analgesia. Adherence to both regimens was reinforced using a daily checklist and protocol guidance sheets. Discharge decision was made using pre-agreed criteria. The primary endpoint was postoperative stay, and achievement of independence milestones. Secondary endpoints were postoperative complications, readmission rates, and mortality. Analysis was by intention to treat.
                Seventy patients were recruited. Approximately one fourth underwent TME. Median ages were similar (69.3 vs. 73.0 years). The median stay was significantly reduced in the multimodal group (5 vs. 7 days; P < 0.001, Mann-Whitney U test). Patients in the control arm were 2.5 times as likely to require a postoperative stay of more than 5 days. Patients in the multimodal group had less cardiorespiratory and anastomotic complications but more readmissions. There were 2 deaths, both controls.
                This RCT provides level 1b evidence that a multimodal management protocol can significantly reduce postoperative stay following colorectal cancer surgery. Morbidity and mortality are not increased. In the latter 1990s, adjuvant chemotherapy for completely resected Stage III colorectal cancer remained controversial in Japan. We conducted two independent randomized controlled trials in patients with Stage III colon and rectal cancer.
                Patients were randomly assigned to receive surgery alone or surgery followed by treatment with UFT (400 mg/m²/day), given for five consecutive days per week for 1 year. The primary endpoint was relapse-free survival (RFS), and the secondary endpoint was overall survival (OS).
                A total of 334 patients with colon cancer and 276 with rectal cancer were enrolled. The patients' characteristics were similar between the UFT group and the Surgery-alone group. There was no significant difference in RFS or OS in colon cancer. In rectal cancer, however, RFS and OS were significantly better in the UFT group than in the Surgery-alone group. The only grade 4 toxicity in the UFT group was diarrhea, occurring in one patient with colon cancer and one patient with rectal cancer.
                Postoperative adjuvant chemotherapy with UFT is successfully tolerated and improves RFS and OS in patients with Stage III rectal cancer. In colon cancer, the expected benefits were not obtained (hazard ratio = 0.89). To analyze total mesorectal excision (TME) for rectal cancer by the laparoscopic approach during a prospective nonrandomized trial.
                Improved local control and survival rates in the treatment of rectal cancer have been reported after TME.
                The authors conducted a prospective consecutive series of 100 laparoscopic TMEs for low and mid-rectal tumors. All patients had a sphincter-saving procedure. Case selection, surgical technique, and clinical and oncologic results were reviewed.
                The distal limit of rectal neoplasm was on average 6.1 (range 3-12) cm from the anal verge. The mean operative time was 250 (range 110-540) minutes. The conversion rate was 12%. Excluding the patient who stayed 104 days after a severe fistula and reoperation, the mean postoperative stay was 12.05 (range 5-53) days. The 30-day mortality was 2% and the overall postoperative morbidity was 36%, including 17 anastomotic leaks. Of 87 malignant cases, 70 (80.4%) had a minimum follow-up of 12 months, with a median follow-up of 45.7 (range 12-72) months. During this period 18.5% (13/70) died of cancer and 8.5% (6/70) are alive with metastatic disease. The port-site metastasis rate was 1.4% (1/70): a rectal cancer stage IV presented with a parietal recurrence at 17 months after surgery. The locoregional pelvic recurrence rate was 4.2% (3/70): three rectal cancers stage III at 19, 13, and 7 postoperative months.
                Laparoscopic TME is a feasible but technically demanding procedure (12% conversion rate). This series confirms the safety of the procedure, while oncologic results are at present comparable to the open published series with the limitation of a short follow-up period. Further studies and possibly randomized series will be necessary to evaluate long-term clinical outcome in cancer patients. Total mesorectal excision (TME) is the surgical gold standard treatment for middle and low third rectal carcinoma. Laparoscopy has gradually become accepted for the treatment of colorectal malignancy after a long period of questions regarding its safety. The purposes of this study were to examine prospectively our experience with laparoscopic TME and high rectal resections, to evaluate the surgical outcomes and oncologic adequacy, and to discuss the role of this procedure in the treatment of rectal cancer.
                Between December 1992 and December 2004, all patients who underwent elective laparoscopic sphincter preserving rectal resection for rectal cancer were enrolled prospectively in this study. Data collection included preoperative, operative, postoperative and oncologic results with long-term follow-up.
                A total of 218 patients were operated on during the study period: 142 patients underwent laparoscopic TME and 76 patients underwent anterior resection. Of the TME patients, 122 patients were operated using the double-stapling technique, and 20 patients underwent colo-anal anastomosis with hand-sewn sutures. Mean operative time was 138 min (range, 107-205), and mean blood loss was 120 ml (range, 30-350). Conversion to open surgery occurred in 26 cases (12%). Mortality rate during the first 30 days was 1%. Anastomotic leaks were observed in 10.5% of the patients. Of these, 61.9% needed reoperation and diverting stoma, and the rest were treated conservatively. Three patients had postoperative bleeding requiring relaparoscopy. Other minor complications (infection and urinary retention) occurred in 9.1% of patients. Mean ambulation time and mean hospital stay were 1.6 days (range, 1-5) and 6.4 days (range, 3-28) , respectively. Patients were followed for a mean period of 57 months. No port site metastases were observed during follow-up. The recurrence rate was 6.8 %. Overall survival rate was 67% after 5 years and 53.5% after 10 years.
                Laparoscopic anterior resection and TME with anal sphincter preservation for rectal cancer is feasible and safe. The short- and long-term outcomes reported in this series are comparable with those of conventional surgery. With conventional blunt surgical resection of rectal cancer, local recurrence rates are high and the individual surgeon putatively influences patient outcome. With total mesorectal excision (TME) local recurrence rates have been reduced and intersurgeon variability may be less important. The 'TME project' was a collaborative project that included surgical workshops in Stockholm between 1994 and 1997. The aim of this study was to assess the impact of the project on the practice of rectal cancer surgery in Stockholm and to analyse whether surgeon case volume and participation in the workshops influenced patient outcome.
                All 652 patients who had an abdominal resection for rectal cancer in Stockholm between 1995 and 1997 were included. Outcome was compared in patients operated on by teams that included high-volume surgeons (more than 12 operations per year) with teams that included low-volume surgeons (12 operations or fewer per year), as well as between teams that including workshop participants and non-participants.
                Forty-six surgeons operated on the 652 patients. Five high-volume surgeons operated on 48 per cent of the patients. In these, outcome was significantly better than in patients treated by low-volume surgeons (local recurrence rate 4 versus 10 per cent (P = 0.02); rate of rectal cancer death 11 versus 18 per cent (P = 0.007)). Twenty-six surgeons were workshop participants and performed 93 per cent of the operations. Radiotherapy, TME and sphincter-preserving surgery were more common among patients treated by workshop participants.
                The TME project has had an impact on rectal cancer surgical practice in Stockholm. Variability in patient outcome was mainly related to case volume, with better results obtained in patients treated by high-volume surgeons. The aim of the current study is to report the long-term outcomes after laparoscopic-assisted surgery compared with conventional open surgery within the context of the UK MRC CLASICC trial. Results from randomized trials have indicated that laparoscopic surgery for colon cancer is as effective as open surgery in the short term. Few data are available on rectal cancer, and long-term data on survival and recurrence are now required.
                The United Kingdom Medical Research Council Conventional versus Laparoscopic-Assisted Surgery in Colorectal Cancer (UK MRC CLASICC; clinical trials number ISRCTN 74883561) trial study comparing conventional versus laparoscopic-assisted surgery in patients with cancer of the colon and rectum. The randomization ratio was 2:1 in favor of laparoscopic surgery. Long-term outcomes (3-year overall survival [OS], disease-free survival [DFS], local recurrence, and quality of life [QoL]) have now been determined on an intention-to-treat basis.
                Seven hundred ninety-four patients were recruited (526 laparoscopic and 268 open). Overall, there were no differences in the long-term outcomes. The differences in survival rates were OS of 1.8% (95% CI, -5.2% to 8.8%; P = .55), DFS of -1.4% (95% CI, -9.5% to 6.7%; P = .70), local recurrence of -0.8% (95% CI, -5.7% to 4.2%; P = .76), and QoL (P > .01 for all scales). Higher positivity of the circumferential resection margin was reported after laparoscopic anterior resection (AR), but it did not translate into an increased incidence of local recurrence.
                Successful laparoscopic-assisted surgery for colon cancer is as effective as open surgery in terms of oncological outcomes and preservation of QoL. Long-term outcomes for patients with rectal cancer were similar in those undergoing abdominoperineal resection and AR, and support the continued use of laparoscopic surgery in these patients. To assess with a single-blinded, multicenter, randomized trial, the postoperative results in patients undergoing sphincter-saving rectal resection for cancer without preoperative mechanical bowel preparation (MBP).
                The collective evidence from literature strongly suggests that MBP, before elective colonic surgery, is of no benefit in terms of postoperative morbidity. Very few data and no randomized study are available for rectal surgery and preliminary results conclude toward the safety of rectal resection without MBP.
                From October 2007 to January 2009, patients scheduled for elective rectal cancer sphincter-saving resection were randomized to receive preoperative MBP (ie, retrograde enema and oral laxatives) or not. Primary endpoint was the overall 30-day morbidity rate. Secondary endpoints included mortality rate, anastomotic leakage rate, major morbidity rate (Dindo III or more), degree of discomfort for the patient, and hospital stay.
                A total of 178 patients (103 men), including 89 in both groups (no-MBP and MBP groups), were included in the study. The overall and infectious morbidity rates were significantly higher in no-MBP versus MBP group, 44% versus 27%, P = 0.018, and 34% versus 16%, P = 0.005, respectively. Regarding both anastomotic leakage and major morbidity rates, there was no significant difference between no-MBP and MBP group: 19% versus 10% (P = 0.09) and 18% versus 11% (P = 0.69), respectively. Moderate or severe discomfort was reported by 40% of prepared patients. Mortality rate (1.1% vs 3.4%) and mean hospital stay (16 vs 14 days) did not differ significantly between both groups.
                This first randomized trial demonstrated that rectal cancer surgery without MBP was associated with higher risk of overall and infectious morbidity rates without any significant increase of anastomotic leakage rate. Thus, it suggests continuing to perform MBP before elective rectal resection for cancer.
Based on evidence mainly from non-randomized studies, LTME appears to have clinically measurable short-term advantages in patients with primary resectable rectal cancer. The long-term impact on oncological endpoints awaits the findings from large on-going randomized trials.