Treatment in certified cancer centers is related to better survival in patients with colon and rectal cancer: evidence from a large German cohort study.

BACKGROUND: Certified cancer centers aim to ensure high-quality care by establishing structural and procedural standards according to evidence-based guidelines. Despite the high clinical and health policy relevance, evidence from a nation-wide study for the effectiveness of care for colorectal cancer in certified centers vs. other hospitals in Germany is still missing. METHODS: In a retrospective cohort study covering the years 2009-2017, we analyzed patient data using demographic information, diagnoses, and treatments from a nationwide statutory health insurance enriched with information on certification. We investigated whether patients with incident colon or rectal cancer did benefit from primary therapy in a certified cancer center. We used relative survival analysis taking into account mortality data of the German population and adjustment for patient and hospital characteristics via Cox regression with shared frailty for patients in hospitals with and without certification. RESULTS: The cohorts for colon and rectal cancer consisted of 109,518 and 51,417 patients, respectively, treated in a total of 1052 hospitals. 37.2% of patients with colon and 42.9% of patients with rectal cancer were treated in a certified center. Patient age, sex, comorbidities, secondary malignoma, and distant metastases were similar across groups (certified/non-certified) for both colon and rectal cancer. Relative survival analysis showed significantly better survival of patients treated in a certified center, with 68.3% (non-certified hospitals 65.8%) 5-year survival for treatment of colon cancer in certified (p < 0.001) and 65.0% (58.8%) 5-year survival in case of rectal cancer (p < 0.001), respectively. Cox regression with adjustment for relevant covariates yielded a lower hazard of death for patients treated in certified centers for both colon (HR = 0.92, 95% CI = 0.89-0.95) and rectal cancer (HR = 0.92, 95% CI = 0.88-0.95). The results remained robust in a series of sensitivity analyses. CONCLUSIONS: This large cohort study yields new important evidence that patients with colorectal cancer have a better chance of survival if treated in a certified cancer center. Certification thus provides one powerful means to improve the quality of care for colorectal cancer. To decrease the burden of disease, more patients should thus receive cancer care in a certified center.

Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence.

OBJECTIVE: The aim of this study was to evaluate oncological outcome for patients with and without anastomotic leakage after colon or rectal cancer surgery. SUMMARY OF BACKGROUND DATA: The role of anastomotic leakage in oncological outcome after colorectal cancer surgery is still topic of debate and impact on follow-up and consideration for further treatment remains unclear. METHODS: Patients included in the international, multicenter, non-inferior, open label, randomized, controlled trials COLOR and COLOR II, comparing laparoscopic surgery for curable colon (COLOR) and rectal (COLOR II) cancer with open surgery, were analyzed. Patients operated by abdominoperineal excision were excluded. Both univariate and multivariate analyses were performed to investigate the impact of leakage on overall survival, disease-free survival, local and distant recurrences, adjusted for possible confounders. Primary endpoints in the COLOR and COLOR II trial were disease-free survival and local recurrence at 3-year follow-up, respectively, and secondary endpoints included anastomotic leakage rate. RESULTS: For colon cancer, anastomotic leakage was not associated with increased percentage of local recurrence or decreased disease-free-survival. For rectal cancer, an increase of local recurrences (13.3% vs 4.6%; hazard ratio 2.96; 95% confidence interval 1.38-6.34; P = 0.005) and a decrease of disease-free survival (53.6% vs 70.9%; hazard ratio 1.67; 95% confidence interval 1.16-2.41; P = 0.006) at 5-year follow-up were found in patients with anastomotic leakage. CONCLUSION: Short-term morbidity, mortality, and long-term oncological outcomes are negatively influenced by the occurrence of anastomotic leakage after rectal cancer surgery. For colon cancer, no significant effect was observed; however, due to low power, no conclusions on the influence of anastomotic leakage on outcomes after colon surgery could be reached. Clinical awareness of increased risk of local recurrence after anastomotic leakage throughout the follow-up is mandatory.Trial Registration: Registered with ClinicalTrials.gov, number NCT00387842 and NCT00297791.

Transanal total mesorectal excision: short- and long-term results of the first hundred cases of a certified colorectal cancer center in Germany.

BACKGROUND: Since 2010, laparoscopic transanal total mesorectal excision (TaTME) has been increasingly used for low and very low rectal cancer. It is supposed to improve visibility and access to the dissection planes in the pelvis. This study reports on short- and long-term outcomes of the first 100 consecutive patients treated with TaTME in a certified German colorectal cancer center. PATIENTS AND METHODS: Data were derived from digital patient files and official cancer registry reports for patients with TaTME tumor surgery between July 2014 and January 2020. The primary outcome was the 3-year local recurrence rate and local recurrence-free survival (LRFS). Secondary endpoints included overall survival (OAS), disease-free survival (DFS), operation time, completeness of local tumor resection, lymph node resection, and postoperative complications. The Kaplan-Meier method was employed for the survival analyses; competing risks were considered in the time-to-event analysis. RESULTS: During the observation period, the average annual operation time decreased from 272 to 178 min. Complete local tumor resection was achieved in 97% of the procedures. Major postoperative complications (Clavien-Dindo 3-4) occurred in 11% of the cases. At a median follow-up time of 2.7 years, three patients had suffered from a local recurrence. Considering competing risks, this corresponds to a 3-year cumulative incidence rate for local recurrence of 2.2% and a 3-year LRFS of 81.9%. 3-year OAS was 82.9%, and 3-year DFS was 75.7%. CONCLUSION: TaTME is associated with favorable short and long-term outcomes. Since it is technically demanding, structured training programs and more research on the topic are indispensable.

Correction to: Laparoscopic and open surgery in rectal cancer patients in Germany: short and long-term results of a large 10-year population-based cohort.

The article, "Laparoscopic and open surgery in rectal cancer patients in Germany: short and long­term results of a large 10-year population-based cohort," written by Valentin Schnitzbauer, Michael Gerken, Stefan Benz, Vinzenz Völkel,, Teresa Draeger, Alois Fürst, and Monika Klinkhammer-Schalke was originally published electronically on the publisher's internet portal (currently SpringerLink) on 30 May 2019 without open access. With the author(s)' decision to opt for Open Choice the copyright of the article changed on September 18, 2019 to © The Author(s) [Year] and the article is forthwith distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits use, duplication, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit original author(s) and the source, provide a link to the Creative Commons licence and indicate if changes were made.

Laparoscopic and open surgery in rectal cancer patients in Germany: short and long-term results of a large 10-year population-based cohort.

BACKGROUND: Rectal cancer is frequent in Germany and worldwide. Several studies have assessed laparoscopic surgery as a treatment option and most have shown favorable results. However, long-term oncologic safety remains a controversial issue. METHODS: The current dataset derives from 30 clinical cancer registries in Germany and includes 16,378 patients diagnosed with rectal cancer between 2007 and 2016. Outcomes were 90-day mortality, overall survival (OS), local recurrence-free survival (RFS) and relative survival of patients treated with either open or laparoscopic surgery. Multivariable logistic regression was used to evaluate factors that affected the probability of a patient undergoing laparoscopic surgery as well as to evaluate short-term mortality. OS and RFS were analyzed by Kaplan-Meier plots and multivariable Cox regression conducted separately for UICC stages I-III, tumor location, and sex as well as by propensity score matching followed by univariable and multivariable survival analysis. RESULTS: Of 16,378 patients, 4540 (27.7%) underwent laparoscopic surgery, a trend which increased during the observation period. Patients undergoing laparoscopy attained better results for 90-day mortality (odds ratio, OR 0.658, 95% confidence interval, CI 0.526-0.822). The 5-year OS rate in the laparoscopic group was 82.6%, vs. 76.6% in the open surgery group, with a hazard ratio (HR) of 0.819 in multivariable Cox regression (95% CI 0.747-0.899, p < 0.001). The laparoscopic group showed a better 5-year RFS, with 81.8 vs. 74.3% and HR 0.770 (95% CI 0.705-0.842, p < 0.001). The 5-year relative survival rates were also in favor of laparoscopy, with 93.1 vs. 88.4% (p = 0.012). CONCLUSION: Laparoscopic surgery for rectal cancer can be performed safely and, according to this study, is associated with an oncological outcome superior to that of the open procedure. Therefore, in the absence of individual contraindications, it should be considered as a standard approach.

Bowel Obstruction and Ventral Hernia After Laparoscopic Versus Open Surgery for Rectal Cancer in A Randomized Trial (COLOR II).

OBJECTIVE: The aim of this study was to evaluate the risk of bowel obstruction, incisional, and parastomal hernia following laparoscopic versus open surgery for rectal cancer. SUMMARY BACKGROUND DATA: Laparoscopic surgery for rectal cancer has been adopted worldwide, after trials reported similar oncological outcomes compared with open surgery. Little is known about long-term morbidity, including bowel obstruction, incisional, and parastomal hernia following surgery. METHODS: Patients included in the international, multicenter, noninferior, open-label, randomized COLOR II trial were followed for five years. Primary endpoint was local recurrence at 3-year follow-up. Secondary endpoints included bowel obstruction, incisional and parastomal hernia within 5 years, and the current article reports on these secondary endpoints. RESULTS: All 1044 patients included in the COLOR II trial were analyzed. There was no difference in risk of bowel obstruction, incisional, or parastomal hernia following laparoscopic or open surgery for rectal cancer. CONCLUSION: Based on long-term morbidity outcomes, laparoscopic surgery for rectal cancer could be considered a routine technique as there are no differences with open surgery.

Laparoscopic and open resection of rectal cancer-is age an effect modifier for short- and long-term survival?

INTRODUCTION: Rectal cancer is a frequently diagnosed tumor worldwide. Various studies have shown the noninferiority or even slight superiority of laparoscopic resection. However, there is no clear recommendation on whether age should influence the choice of surgical approach. MATERIALS AND METHODS: This study compared outcomes of laparoscopic and open surgery in rectal cancer patients. Perioperative mortality and 5-year overall, relative, and recurrence-free survival rates were analyzed separately for three age groups. Data originate from 30 regional German cancer registries that cover approximately one quarter of the German population. All primary nonmetastatic rectal adenocarcinoma cases with surgery between 2005 and 2014 were eligible for inclusion. To compare survival rates, Kaplan-Meier analysis, a relative survival model, and multivariable Cox regression were used; a sensitivity analysis assessed bias by exclusion. RESULTS: Ten thousand seven hundred fifty-four patients were included in the analysis. The mean laparoscopy rate was 23.0% and increased over time. Analysis of 30-day postoperative mortality rates revealed advantages for laparoscopically treated patients, although the significance level was not reached in any age group. Regarding 5-year overall survival, laparoscopy generally seems to be the superior approach, whereas for recurrence-free survival, an age-dependent gradient in effect size was observed: with a hazard ratio (HR) of 0.703 for laparoscopy, patients under 60 years benefitted more from the minimally invasive approach than older patients (septuagenarians, HR 0.923). CONCLUSION: Laparoscopy shows similar results to the open approach in terms of postoperative survival in all age groups. Concerning long-term outcomes, younger patients benefitted most from the minimally invasive approach.

[Long-Term Survival of Patients with Colon and Rectum Carcinomas: Is There a Difference Between Cancer Centers and Non-Certified Hospitals?] / Langzeitüberleben von Patienten mit Kolon- und Rektumkarzinomen: Ein Vergleich von Darmkrebszentren und nicht zertifizierten Krankenhäusern.

AIM OF THE STUDY: Hospitals specializing in the treatment of colorectal carcinoma with high quality standards can apply for certification as colorectal cancer centers. The aim of this study was to clarify if there is a substantial difference between certified and non-certified hospitals in terms of long-term survival of patients. METHODS: This is a population-based retrospective cohort study using the data of a clinical cancer registry (Tumorzentrum Regensburg) which covers a southern German region of approximately 1.1 million inhabitants. 4302 patients with colorectal carcinoma who underwent radically surgery between 2004 and 2013 were divided into 4 groups for comparing certified and non-certified centers as well as the situation before and after certification. 3-year overall survival is displayed using Kaplan-Meier analysis, multivariate cox regression and relative survival models. Sensitivity analysis for missing data was conducted. RESULTS: The estimated 3-year survival rates of patients treated at certified compared to non-certified centers were 71.6% and 63.6%, respectively. Even after adjusting for possible confounders, treatment at certified centers was associated with significant survival benefits for patients (HR=0.808, CI: 0.665-0.982). Comparison of colorectal cancer centers before and after certification showed almost identical 3-year survival rates. Cox regression analysis also showed no substantial difference between the two (HR=0.964, CI: 0.848-1.096). CONCLUSION: Patients with colorectal cancer treated in certified compared to non-certified centers show long-term survival benefits. Patients of certified colorectal cancer centers show long-term survival benefits compared to those treated at non-certified centers. Early and successful implementation of high quality standards could explain why survival rates before and after certification do not differ.

Long-term oncologic outcomes after laparoscopic vs. open colon cancer resection: a high-quality population-based analysis in a Southern German district.

BACKGROUND: Over 20 years after the introduction of laparoscopic surgery for colon cancer, many surgeons still prefer the open approach. Whereas randomized controlled trials (RCTs) have proven the oncologic safety of laparoscopy, long-term data depicting daily clinical routine are scarce. METHODS: This population-based cohort study compares 5-year overall, relative, and recurrence-free survival rates after laparoscopic and open colon carcinoma surgery. Data derive from an independent German cancer registry encompassing all tumor patients within a political district of 1.1 million inhabitants. The final analysis included 2669 patients with major elective resection of primary non-metastatic colonic adenocarcinoma between January 1, 2004 and December 31, 2013. Survival rates were compared using Kaplan-Meier analyses, relative survival models, and multivariate Cox regression. Sensitivity analysis quantified selection bias. RESULTS: The proportion of laparoscopic procedures increased from 9.7 to 25.8% in 2011 and dropped again to 15.8% at the end of observation period. Laparoscopy patients were younger, had a lower tumor stage, and were more likely to receive postoperative chemotherapy. Overall, relative, and recurrence-free survival was significantly superior or equivalent in Kaplan-Meier analysis (5-year overall survival rate open vs. laparoscopic: 69.0 vs. 80.2%, p < 0.001). The superiority of laparoscopy mostly remained stable after adjusting for confounders, although significance was only reached in T1-3 patients without lymph node metastases (overall survival: hazard ratio (HR) 0.654; 95% confidence interval (CI) 0.446-0.958; p = 0.029). CONCLUSION: Laparoscopy is a safe and promising alternative to the open approach in daily clinic practice. These favorable outcomes require future confirmation by high-quality studies outside the setting of RTCs.

Long-term oncologic outcomes after laparoscopic versus open rectal cancer resection: a high-quality population-based analysis in a Southern German district.

BACKGROUND: An increasing number of rectal carcinoma resections in Germany and worldwide are performed laparoscopically. The recently published COLOR II trial demonstrated the oncologic safety of this surgical approach. It remains unclear whether these findings can be transferred to clinical practice. PATIENTS AND METHODS: This population-based retrospective cohort study aimed to evaluate 5-year overall, relative, disease-free, and local recurrence-free survival of rectal cancer patients treated by open surgery and laparoscopy. Data from a southern German region of 1.1 million inhabitants were collected by an official clinical cancer registry. All primary non-metastatic rectal adenocarcinoma cases with surgery between 2004 and 2013 were eligible for inclusion. To compare survival rates, Kaplan-Meier analyses, relative survival models, and multivariate Cox regression were applied; a sensitivity analysis assessed bias by exclusion. RESULTS: Finally, 1507 patients with a median follow-up time of 7.1 years were included. Of these patients, 28.4% underwent laparoscopic procedures, with an increasing rate over time. Patients with tumors of the upper or middle rectum, younger patients, and patients of specialized colorectal cancer centers were more likely to undergo laparoscopy. After 5 years, 80.4% of laparoscopy patients were still alive, compared to 68.6% in the open group (p < 0.001). Moreover, laparoscopy was associated with superior local recurrence-free survival rates. This advantage was also significant in multivariate analysis (HR 0.70, 95% CI 0.52-0.92). CONCLUSION: Laparoscopic rectal cancer surgery can be considered safe in daily clinical practice. This should be confirmed by future studies outside the setting of randomized trials.

Laparoscopic surgery in patients with colon cancer: a population-based analysis.

BACKGROUND: The long-term outcomes after laparoscopic surgery for colon cancer remain debatable, as randomized trials have reported similar outcomes for open and laparoscopic surgery but population-based data are scarce. Thus, it is unclear whether, outside of clinical trials, laparoscopic surgery that is performed as a standard clinical treatment has detrimental effects on patients' long-term survival. METHODS: This study examined a unified database of 30 German regional cancer registries for patients with colorectal cancer who were diagnosed between 2003 and 2011. Among 216,682 patients with colorectal carcinoma, we identified 37,068 patients with Union for International Cancer Control stage I-III colon carcinoma (>12 cm from the anal verge), including 3825 patients (10.38 %) who underwent laparoscopic surgery. Multivariate Cox regression analyses were also used to evaluate factors that influenced the likelihood of a patient undergoing laparoscopic surgery. Kaplan-Meier analysis with the log-rank test was used to analyse differences in short- and long-term survival outcomes after open or laparoscopic surgery. RESULTS: Younger age, lower T-stage, and left-sided surgery were independent predictors of the patient undergoing laparoscopic surgery (all, p < 0001). The 30-day mortality rate was significantly lower for patients who underwent laparoscopic surgery for left-sided tumours (odds ratio [OR] 0.49; 95 % confidence interval [CI] 0.33-0.77). Compared to open surgery, laparoscopic surgery was a significant and independent predictor of prolonged long-term survival for right- and left-sided surgeries (right-side, OR 0.67; 95 % CI 0.56-0.82; left-sided, OR 0.70; 95 % CI 0.62-0.78). CONCLUSION: Our results indicate that laparoscopic surgery provides favourable outcomes even when used outside controlled trials and should be considered as a standard treatment for patients with colon cancer.

Conversions in laparoscopic surgery for rectal cancer.

BACKGROUND: Laparoscopic surgery offers patients with rectal cancer short-term benefits and similar survival rates as open surgery. However, selecting patients who are suitable candidates for laparoscopic surgery is essential to prevent intra-operative conversion from laparoscopic to open surgery. Clinical and pathological variables were studied among patients who had converted laparoscopic surgeries within the COLOR II trial to improve patient selection for laparoscopic rectal cancer surgery. METHODS: Between January 20, 2004, and May 4, 2010, 1044 patients with rectal cancer enrolled in the COLOR II trial and were randomized to either laparoscopic or open surgery. Of 693 patients who had laparoscopic surgery, 114 (16 %) were converted to open surgery. Predictive factors were studied using multivariate analyses, and morbidity and mortality rates were determined. RESULTS: Factors correlating with conversion were as follows: age above 65 years (OR 1.9; 95 % CI 1.2-3.0: p = 0.003), BMI greater than 25 (OR 2.7; 95 % CI 1.7-4.3: p < 0.001), and tumor location more than 5 cm from the anal verge (OR 0.5; CI 0.3-0.9). Gender was not significantly related to conversion (p = 0.14). In the converted group, blood loss was greater (p < 0.001) and operating time was longer (p = 0.028) compared with the non-converted laparoscopies. Hospital stay did not differ (p = 0.06). Converted procedures were followed by more postoperative complications compared with laparoscopic or open surgery (p = 0.041 and p = 0.042, respectively). Mortality was similar in the laparoscopic and converted groups. CONCLUSIONS: Age above 65 years, BMI greater than 25, and tumor location between 5 and 15 cm from the anal verge were risk factors for conversion of laparoscopic to open surgery in patients with rectal cancer.

German S3 guidelines: anal abscess and fistula (second revised version).

BACKGROUND: The incidence of anal abscess and fistula is relatively high, and the condition is most common in young men. METHODS: This is a revised version of the German S3 guidelines first published in 2011. It is based on a systematic review of pertinent literature. RESULTS: Cryptoglandular abscesses and fistulas usually originate in the proctodeal glands of the intersphincteric space. Classification depends on their relation to the anal sphincter. Patient history and clinical examination are diagnostically sufficient in order to establish the indication for surgery. Further examinations (endosonography, MRI) should be considered in complex abscesses or fistulas. The goal of surgery for an abscess is thorough drainage of the focus of infection while preserving the sphincter muscles. The risk of abscess recurrence or secondary fistula formation is low overall. However, they may result from insufficient drainage. Primary fistulotomy should only be performed in case of superficial fistulas. Moreover, it should be done by experienced surgeons. In case of unclear findings or high fistulas, repair should take place in a second procedure. Anal fistulas can be treated only by surgical intervention with one of the following operations: laying open, seton drainage, plastic surgical reconstruction with suturing of the sphincter (flap, sphincter repair, LIFT), and occlusion with biomaterials. Only superficial fistulas should be laid open. The risk of postoperative incontinence is directly related to the thickness of the sphincter muscle that is divided. All high anal fistulas should be treated with a sphincter-saving procedure. The various plastic surgical reconstructive procedures all yield roughly the same results. Occlusion with biomaterial results in lower cure rate. CONCLUSION: In this revision of the German S3 guidelines, instructions for diagnosis and treatment of anal abscess and fistula are described based on a review of current literature.

Solo-surgical laparoscopic cholecystectomy with a joystick-guided camera device: a case-control study.

BACKGROUND: This study aimed to evaluate the implementation of a joystick-controlled camera holder (Soloassist; Actormed, Barbing, Germany) in laparoscopic cholecystectomy as so-called solo-surgery compared with the standard operation. METHODS: Of the 123 patients included in this study, 63 underwent laparoscopic cholecystectomy using the Soloassist system and were compared with 60 patients who underwent laparoscopic cholecystectomy with human assistance. The two groups did not differ significantly in terms of age, sex, body mass index, or American Society of Anesthesiology classification. The surgeons were divided into those highly experienced and those experienced with the new camera holder. The operation times were measured, including setup and dismantling of the system. The assessment also included complications, postoperative hospital stay, measurement of human resources in terms of personnel/minutes/operation, and subjective evaluation of the camera-guiding device by the surgeons. RESULTS: The hospital stay and operation-related complications were not enhanced in the Soloassist group. The differences in core operation time (p = 0.008) and total operating time (p = 0.001) significantly favored the human assistant. Whereas the absolute duration of surgery was longer, the relative operating time (in personnel/minutes/operation) was significantly shorter (p < 0.001). In 4.8 % of the cases, the operation could not be performed completely with the camera-holding device. Clinically relevant postoperative complications did not occur. The experience of the surgeons did not differ significantly. The subjective evaluation regarding handling, image quality, effort, and satisfaction demonstrated high acceptance of the Soloassist system. CONCLUSIONS: The camera-guiding device can be implemented without increased complications. The Soloassist system is safe and can be operated even by colleagues without system experience. All the surgeons rated their satisfaction with the system as very good to excellent. Although the operating times were longer than with the standard camera guidance, the absolute overall staff time was reduced.

Long-term oncologic outcome after laparoscopic surgery for rectal cancer.

BACKGROUND: Recent studies demonstrated favorable short- and mid-term results after laparoscopic surgery for rectal cancer. However, long-term results from large series are lacking. The present study analyses long-term results of laparoscopic rectal cancer surgery from a large-volume center. METHODS: From January 1998 until March 2005, 225 patients underwent laparoscopic rectal resection due to carcinoma at the Medical Centre of the University of Regensburg. From 224 patients, a follow-up over 10 years was performed using the data of the Tumour Centre of the University of Regensburg. The data were analysed using oncological data (tumour recurrence) as well as overall survival. In addition, the effect of conversion to open resection on overall survival was analysed. RESULTS: With a median of 10 years at follow-up, the overall and disease-free survival was 50.5 and 50.1 %, respectively. Local recurrence of all patients was 5.8 % and none of the converted patients was within this group. The median time interval for the development of local recurrence was 30 months. Six of the 13 patients with local recurrence (46.1 %) had received neoadjuvant radiochemotherapy before surgery. Patients with a conversion to open surgery had primarily a significantly worse outcome than patients resected completely laparoscopically (p = 0.003). However, this difference was no longer apparent using a multivariant analysis (hazard ratio 1.221; p = 0.478). CONCLUSIONS: Overall survival and local recurrence rate of patients undergoing laparoscopic resection of rectal cancer are comparable to open surgery. However, in our analysis, patients undergoing laparoscopic anterior resection had a higher survival rate compared with patients with abdominoperineal resection.

Laparoscopic versus open surgery for rectal cancer (COLOR II): short-term outcomes of a randomised, phase 3 trial.

BACKGROUND: Laparoscopic surgery as an alternative to open surgery in patients with rectal cancer has not yet been shown to be oncologically safe. The aim in the COlorectal cancer Laparoscopic or Open Resection (COLOR II) trial was to compare laparoscopic and open surgery in patients with rectal cancer. METHODS: A non-inferiority phase 3 trial was undertaken at 30 centres and hospitals in eight countries. Patients (aged ≥18 years) with rectal cancer within 15 cm from the anal verge without evidence of distant metastases were randomly assigned to either laparoscopic or open surgery in a 2:1 ratio, stratified by centre, location of tumour, and preoperative radiotherapy. The study was not masked. Secondary (short-term) outcomes-including operative findings, complications, mortality, and results at pathological examination-are reported here. Analysis was by modified intention to treat, excluding those patients with post-randomisation exclusion criteria and for whom data were not available. This study is registered with ClinicalTrials.gov, number NCT00297791. FINDINGS: The study was undertaken between Jan 20, 2004, and May 4, 2010. 1103 patients were randomly assigned to the laparoscopic (n=739) and open surgery groups (n=364), and 1044 were eligible for analyses (699 and 345, respectively). Patients in the laparoscopic surgery group lost less blood than did those in the open surgery group (median 200 mL [IQR 100-400] vs 400 mL [200-700], p<0·0001); however, laparoscopic procedures took longer (240 min [184-300] vs 188 min [150-240]; p<0·0001). In the laparoscopic surgery group, bowel function returned sooner (2·0 days [1·0-3·0] vs 3·0 days [2·0-4·0]; p<0·0001) and hospital stay was shorter (8·0 days [6·0-13·0] vs 9·0 days [7·0-14·0]; p=0·036). Macroscopically, completeness of the resection was not different between groups (589 [88%] of 666 vs 303 [92%] of 331; p=0·250). Positive circumferential resection margin (<2 mm) was noted in 56 (10%) of 588 patients in the laparoscopic surgery group and 30 (10%) of 300 in the open surgery group (p=0·850). Median tumour distance to distal resection margin did not differ significantly between the groups (3·0 cm [IQR 2·0-4·8] vs 3·0 cm [1·8-5·0], respectively; p=0·676). In the laparoscopic and open surgery groups, morbidity (278 [40%] of 697 vs 128 [37%] of 345, respectively; p=0·424) and mortality (eight [1%] of 699 vs six [2%] of 345, respectively; p=0·409) within 28 days after surgery were similar. INTERPRETATION: In selected patients with rectal cancer treated by skilled surgeons, laparoscopic surgery resulted in similar safety, resection margins, and completeness of resection to that of open surgery, and recovery was improved after laparoscopic surgery. Results for the primary endpoint-locoregional recurrence-are expected by the end of 2013. FUNDING: Ethicon Endo-Surgery Europe, Swedish Cancer Foundation, West Gothia Region, Sahlgrenska University Hospital.

Influence of Laparoscopic Surgery on Cellular Immunity in Colorectal Cancer: A Systematic Review and Meta-Analysis.

Colorectal cancer (CRC) is the third most common cancer worldwide. The main treatment options are laparoscopic (LS) and open surgery (OS), which might differ in their impact on the cellular immunity so indispensable for anti-infectious and antitumor defense. MEDLINE, Embase, Web of Science (SCI-EXPANDED), the Cochrane Library, Google Scholar, ClinicalTrials.gov, and ICTRP (WHO) were systematically searched for randomized controlled trials (RCTs) comparing cellular immunity in CRC patients of any stage between minimally invasive and open surgical resections. A random effects-weighted inverse variance meta-analysis was performed for cell counts of natural killer (NK) cells, white blood cells (WBCs), lymphocytes, CD4+ T cells, and the CD4+/CD8+ ratio. The RoB2 tool was used to assess the risk of bias. The meta-analysis was prospectively registered in PROSPERO (CRD42021264324). A total of 14 trials including 974 participants were assessed. The LS groups showed more favorable outcomes in eight trials, with lower inflammation and less immunosuppression as indicated by higher innate and adaptive cell counts, higher NK cell activity, and higher HLA-DR expression rates compared to OS, with only one study reporting lower WBCs after OS. The meta-analysis yielded significantly higher NK cell counts at postoperative day (POD)4 (weighted mean difference (WMD) 30.80 cells/µL [19.68; 41.92], p < 0.00001) and POD6-8 (WMD 45.08 cells/µL [35.95; 54.21], p < 0.00001). Although further research is required, LS is possibly associated with less suppression of cellular immunity and lower inflammation, indicating better preservation of cellular immunity.

Treatment of Colorectal Cancer in Certified Centers: Results of a Large German Registry Study Focusing on Long-Term Survival.

(1) Background: The WiZen study is the largest study so far to analyze the effect of the certification of designated cancer centers on survival in Germany. This certification program is provided by the German Cancer Society (GCS) and represents one of the largest oncologic certification programs worldwide. Currently, about 50% of colorectal cancer patients in Germany are treated in certified centers. (2) Methods: All analyses are based on population-based clinical cancer registry data of 47.440 colorectal cancer (ICD-10-GM C18/C20) patients treated between 2009 and 2017. The primary outcome was 5-year overall survival (OAS) after treatment at certified cancer centers compared to treatment at other hospitals; the secondary endpoint was recurrence-free survival. Statistical methods included Kaplan-Meier analysis and multivariable Cox regression. (3) Results: Treatment at certified hospitals was associated with significant advantages concerning 5-year overall survival (HR 0.92, 95% CI 0.89, 0.96, adjusted for a broad range of confounders) for colon cancer patients. Concentrating on UICC stage I-III patients, for whom curative treatment is possible, the survival benefit was even larger (colon cancer: HR 0.89, 95% CI 0.84, 0.94; rectum cancer: HR 0.91, 95% CI 0.84, 0.97). (4) Conclusions: These results encourage future efforts for further implementation of the certification program. Patients with colorectal cancer should preferably be directed to certified centers.