Laparoscopic Versus Robot-Assisted Versus Transanal Low Anterior Resection: 3-Year Oncologic Results for a Population-Based Cohort in Experienced Centers.

BACKGROUND: Laparoscopic, robot-assisted, and transanal total mesorectal excision are the minimally invasive techniques used most for rectal cancer surgery. Because data regarding oncologic results are lacking, this study aimed to compare these three techniques while taking the learning curve into account. METHODS: This retrospective population-based study cohort included all patients between 2015 and 2017 who underwent a low anterior resection at 11 dedicated centers that had completed the learning curve of the specific technique. The primary outcome was overall survival (OS) during a 3-year follow-up period. The secondary outcomes were 3-year disease-free survival (DFS) and 3-year local recurrence rate. Statistical analysis was performed using Cox-regression. RESULTS: The 617 patients enrolled in the study included 252 who underwent a laparoscopic resection, 205 who underwent a robot-assisted resection, and 160 who underwent a transanal low anterior resection. The oncologic outcomes were equal between the three techniques. The 3-year OS rate was 90% for laparoscopic resection, 90.4% for robot-assisted resection, and 87.6% for transanal low anterior resection. The 3-year DFS rate was 77.8% for laparoscopic resection, 75.8% for robot-assisted resection, and 78.8% for transanal low anterior resection. The 3-year local recurrence rate was in 6.1% for laparoscopic resection, 6.4% for robot-assisted resection, and 5.7% for transanal procedures. Cox-regression did not show a significant difference between the techniques while taking confounders into account. CONCLUSION: The oncologic results during the 3-year follow-up were good and comparable between laparoscopic, robot-assisted, and transanal total mesorectal technique at experienced centers. These techniques can be performed safely in experienced hands.

Comparison of laparoscopic versus robot-assisted versus transanal total mesorectal excision surgery for rectal cancer: a retrospective propensity score-matched cohort study of short-term outcomes.

BACKGROUND: Laparoscopic total mesorectal excision (TME) surgery for rectal cancer has important technical limitations. Robot-assisted and transanal TME (TaTME) may overcome these limitations, potentially leading to lower conversion rates and reduced morbidity. However, comparative data between the three approaches are lacking. The aim of this study was to compare short-term outcomes for laparoscopic TME, robot-assisted TME and TaTME in expert centres. METHODS: Patients undergoing rectal cancer surgery between 2015 and 2017 in expert centres for laparoscopic, robot-assisted or TaTME were included. Outcomes for TME surgery performed by the specialized technique in the expert centres were compared after propensity score matching. The primary outcome was conversion rate. Secondary outcomes were morbidity and pathological outcomes. RESULTS: A total of 1078 patients were included. In rectal cancer surgery in general, the overall rate of primary anastomosis was 39.4, 61.9 and 61.9 per cent in laparoscopic, robot-assisted and TaTME centres respectively (P < 0.001). For specialized techniques in expert centres excluding abdominoperineal resection (APR), the rate of primary anastomosis was 66.7 per cent in laparoscopic, 89.8 per cent in robot-assisted and 84.3 per cent in TaTME (P < 0.001). Conversion rates were 3.7 , 4.6 and 1.9 per cent in laparoscopic, robot-assisted and TaTME respectively (P = 0.134). The number of incomplete specimens, circumferential resection margin involvement rate and morbidity rates did not differ. CONCLUSION: In the minimally invasive treatment of rectal cancer more primary anastomoses are created in robotic and TaTME expert centres.

The results of this study showed similar and acceptable short-term results for laparoscopic, robot-assisted and transanal total mesorectal excision performed in expert centres. In centres with robot-assisted or transanal technique, more primary anastomoses were made.

Morbidity and costs of diverting ileostomy in transanal total mesorectal excision with primary anastomosis for rectal cancer.

BACKGROUND: The role of diverting ileostomy is debated in rectal cancer surgery with primary anastomosis. The aim of this study was to evaluate the associated morbidity and hospital costs of diversion after sphincter saving TaTME surgery. METHODS: All patients undergoing TaTME with primary anastomosis for rectal cancer between January 2012 and December 2019 in a single centre in the Netherlands were included. Patients with diverting ileostomy creation during primary surgery were compared with those without ileostomy. Outcomes included length of hospital stay, anastomotic leakage rates and total hospital costs at 1 year. RESULTS: One hundred and one patients were included in the ileostomy group, and 46 patients were in the non-ileostomy group. The number of female patients was 31 (30.7%) in the ileostomy group and 21 (45.7%) in the non-ileostomy group Mean age was 64.5 ± 11.1 years in the ileostomy group and 62.6 ± 10.7 years in the non-ileostomy group The anastomotic leakage rate was 21.7% in the non-ileostomy group and 15.8% in the ileostomy group (p = 0.385). The grade of leakage and number of anastomotic takedowns did not differ between groups. Mean costs at 1 year after surgery was €26,500.13 in the ileostomy group and €16,852.61 in the non-ileostomy group. The main cost driver was longer total length of hospital stay at 1 year (mean 12.4 ± 13.3 days vs 20.6 ± 12.6 days, p = 0.000). CONCLUSIONS: Morbidity and associated costs after diverting ileostomy are high. The incidence and morbidity of anastomotic leakage was not reduced by creation of an ileostomy. Omission of a diverting ileostomy after TaTME could possibly result in a reduction in treatment associated morbidity and costs.

Three-year outcome after transanal versus laparoscopic total mesorectal excision in locally advanced rectal cancer: a multicenter comparative analysis.

BACKGROUND: For patients with mid and distal rectal cancer, robust evidence on long-term outcome and causal treatment effects of transanal total mesorectal excision (TaTME) is lacking. This multicentre retrospective cohort study aimed to assess whether TaTME reduces locoregional recurrence rate compared to laparoscopic total mesorectal excision (LapTME). METHODS: Consecutive patients with rectal cancer within 12 cm from the anal verge and clinical stage II-III were selected from three institutional databases. Outcome after TaTME (Nov 2011 - Feb 2018) was compared to a historical cohort of patients treated with LapTME (Jan 2000 - Feb 2018) using the inverse probability of treatment weights method. The primary endpoint was three-year locoregional recurrence. RESULTS: A total of 710 patients were analysed, 344 in the TaTME group and 366 in the LapTME group. At 3 years, cumulative locoregional recurrence rates were 3.6% (95% CI, 1.1-6.1) in the TaTME group and 9.6% (95% CI, 6.5-12.7) in the LapTME group (HR = 0.4; 95% CI, 0.23-0.69; p = 0.001). Three-year cumulative disease-free survival rates were 74.3% (95% CI, 68.8-79.8) and 68.6% (95% CI, 63.7-73.5) (HR = 0.82; 95% CI, 0.65-1.02; p = 0.078) and three-year overall survival 87.2% (95% CI, 82.7-91.7) and 82.2% (95% CI, 78.0-86.2) (HR = 0.74; 95% CI, 0.53-1.03; p = 0.077), respectively. In patients who underwent sphincter preservation procedures, TaTME was associated with a significantly better disease-free survival (HR = 0.78; 95% CI, 0.62-0.98; p = 0.033). CONCLUSIONS: These findings suggest that TaTME may improve locoregional recurrence and disease-free survival rates among patients with mid and distal locally advanced rectal cancer.

Locoregional recurrences after transanal total mesorectal excision of rectal cancer during implementation.

BACKGROUND: Transanal total mesorectal excision (TaTME) has been proposed as an approach in patients with mid and low rectal cancer. The TaTME procedure has been introduced in the Netherlands in a structured training pathway, including proctoring. This study evaluated the local recurrence rate during the implementation phase of TaTME. METHODS: Oncological outcomes of the first ten TaTME procedures in each of 12 participating centres were collected as part of an external audit of procedure implementation. Data collected from a cohort of patients treated over a prolonged period in four centres were also collected to analyse learning curve effects. The primary outcome was the presence of locoregional recurrence. RESULTS: The implementation cohort of 120 patients had a median follow up of 21·9 months. Short-term outcomes included a positive circumferential resection margin rate of 5·0 per cent and anastomotic leakage rate of 17 per cent. The overall local recurrence rate in the implementation cohort was 10·0 per cent (12 of 120), with a mean(s.d.) interval to recurrence of 15·2(7·0) months. Multifocal local recurrence was present in eight of 12 patients. In the prolonged cohort (266 patients), the overall recurrence rate was 5·6 per cent (4·0 per cent after excluding the first 10 procedures at each centre). CONCLUSION: TaTME was associated with a multifocal local recurrence rate that may be related to suboptimal execution rather than the technique itself. Prolonged proctoring, optimization of the technique to avoid spillage, and quality control is recommended.

ANTECEDENTES: La escisión total del mesorrecto por vía transanal (Transanal Total Mesorectal Excision, TaTME) se ha propuesto como abordaje quirúrgico en pacientes con cáncer de recto medio e inferior. La técnica TaTME se ha introducido en los Países Bajos mediante un proceso de formación estructurado que incluye la supervisión. Este estudio evaluó el porcentaje de recidiva local durante la fase de implementación de TaTME. MÉTODOS: Se recogieron los resultados oncológicos de los primeros 10 procedimientos realizados mediante TaTME en cada uno de los 12 centros participantes como parte de una auditoría externa de implementación del procedimiento. Se reunió una cohorte más amplia de pacientes procedentes de 4 centros para analizar los efectos de la curva de aprendizaje. El criterio de valoración principal fue la presencia de recidiva locorregional. RESULTADOS: La cohorte de implementación de 120 pacientes tuvo una mediana de seguimiento de 21,9 meses. Los resultados a corto plazo incluyeron una tasa del margen de resección circunferencial positivo del 5% y una tasa de fuga anastomótica del 17,4%. La tasa global de recidiva local en la cohorte de implementación fue del 10% (12/120) con un intervalo medio de recidiva de 15,2 (DE 7) meses. El patrón de recidiva local fue multifocal en 8 de 12 casos (67%). En la cohorte ampliada (n = 266), la tasa global de recidiva fue del 5,6% (4,0%, excluyendo a los primeros 10 pacientes). CONCLUSIÓN: TaTME se asoció con un porcentaje de recidiva local multifocal que puede relacionarse con una ejecución subóptima, más que con la técnica en sí. Se recomienda una supervisión prolongada, la optimización de la técnica para evitar la diseminación tumoral, así como un control de calidad.

Functional complaints and quality of life after transanal total mesorectal excision: a meta-analysis.

BACKGROUND: Total mesorectal excision (TME) gives excellent oncological results in rectal cancer treatment, but patients may experience functional problems. A novel approach to performing TME is by single-port transanal minimally invasive surgery. This systematic review evaluated the functional outcomes and quality of life after transanal and laparoscopic TME. METHODS: A comprehensive search in PubMed, the Cochrane Library, Embase and the trial registers was conducted in May 2019. PRISMA guidelines were used. Data for meta-analysis were pooled using a random-effects model. RESULTS: A total of 11 660 studies were identified, from which 14 studies and six conference abstracts involving 846 patients (599 transanal TME, 247 laparoscopic TME) were included. A substantial number of patients experienced functional problems consistent with low anterior resection syndrome (LARS). Meta-analysis found no significant difference in major LARS between the two approaches (risk ratio 1·13, 95 per cent c.i. 0·94 to 1·35; P = 0·18). However, major heterogeneity was present in the studies together with poor reporting of functional baseline assessment. CONCLUSION: No differences in function were observed between transanal and laparoscopic TME.

ANTECEDENTES: La escisión total del mesorrecto (total mesorectal excision, TME) proporciona excelentes resultados oncológicos en el tratamiento del cáncer de recto, pero los pacientes pueden presentar trastornos funcionales. Un abordaje novedoso para realizar la TME es mediante cirugía transanal mínimamente invasiva de puerto único. En esta revisión sistemática se evaluaron los resultados funcionales y la calidad de vida después de TME transanal (TaTME) y TME laparoscópica (LapTME). MÉTODOS: En mayo de 2019 se realizó una búsqueda exhaustiva en las bases de datos de Pubmed, Biblioteca Cochrane, EMBASE y en los registros de ensayos clínicos. Se utilizaron las guías PRISMA. Los datos para el metaanálisis se agruparon utilizando un modelo de efectos aleatorios. RESULTADOS: Se identificaron un total de 11.660 estudios, de los cuales se incluyeron 14 estudios y 6 resúmenes de congresos con 846 pacientes (599 TaTME/247 LapTME). Un número sustancial de pacientes presentó trastornos funcionales consistentes con el síndrome de resección anterior baja (low anterior resection syndrome, LARS). El metaanálisis no encontró diferencias significativas en los porcentajes de LARS grave entre los dos abordajes (razón de oportunidades, odds ratio, OR 1,13; i.c. del 95% 0,94-1,35; P = 0,18). Sin embargo, los estudios globalmente presentaron una gran heterogeneidad, así como una deficiente información sobre la evaluación funcional basal. CONCLUSIÓN: No se observaron diferencias en la función entre TaTME y LapTME.

Structured training pathway and proctoring; multicenter results of the implementation of transanal total mesorectal excision (TaTME) in the Netherlands.

BACKGROUND: Transanal total mesorectal excision (TaTME) is a new complex technique with potential to improve the quality of surgical mesorectal excision for patients with mid and low rectal cancer. The procedure is technically challenging and has shown to be associated with a relative long learning curve which might hamper widespread adoption. Therefore, a national structured training pathway for TaTME has been set up in the Netherlands to allow safe implementation. The aim of this study was to monitor safety and efficacy of the training program with 12 centers. METHODS: Short-term outcomes of the first ten TaTME procedures were evaluated in 12 participating centers in the Netherlands within the national structured training pathway. Consecutive patients operated during and after the proctoring program for rectal carcinoma with curative intent were included. Primary outcome was the incidence of intraoperative complications, secondary outcomes included postoperative complications and pathological outcomes. RESULTS: In October 2018, 12 hospitals completed the training program and from each center the first 10 patients were included for evaluation. Intraoperative complications occurred in 4.9% of the cases. The clinicopathological outcome reported 100% for complete or nearly complete specimen, 100% negative distal resection margin, and the circumferential resection margin was positive in 5.0% of patients. Overall postoperative complication rate was 45.0%, with 19.2% Clavien-Dindo ≥ III and an anastomotic leak rate of 17.3%. CONCLUSIONS: This study shows that the nationwide structured training program for TaTME delivers safe implementation of TaTME in terms of intraoperative and pathology outcomes within the first ten consecutive cases in each center. However, postoperative morbidity is substantial even within a structured training pathway and surgeons should be aware of the learning curve of this new technique.

Short-term outcomes of transanal completion total mesorectal excision (cTaTME) for rectal cancer: a case-matched analysis.

BACKGROUND: Local excision of early rectal tumors as a rectal preserving treatment is gaining popularity, especially since bowel cancer screening programs result in a shift towards the diagnosis of early stage rectal cancers. However, unfavorable histological features predicting high risk for recurrence within the "big biopsy" may mandate completion total mesorectal excision (cTME). Completion surgery is associated with higher morbidity, poorer specimen quality, and less favorable oncological outcomes compared to primary TME. Transanal approach potentially improves outcome of completion surgery for rectal cancer. The aim of this study was to compare radical completion surgery after local excision for rectal cancer by the transanal approach (cTaTME) with conventional abdominal approach (cTME). METHODS: All consecutive patients who underwent cTaTME for rectal cancer between 2012 and 2017 were case-matched with cTME patients, according to gender, tumor height, preoperative radiotherapy, and tumor stage. Surgical, pathological, and short-term postoperative outcomes were evaluated. RESULTS: In total, 25 patients underwent completion TaTME and were matched with 25 patients after cTME. Median time from local excision to completion surgery was 9 weeks in both groups. In the cTaTME and cTME groups, perforation of the rectum occurred in 4 and 28% of patients, respectively (p = 0.049), leading to poor specimen quality in these patients. Number of harvested lymph nodes was higher after cTaTME (median 15; range 7-47) than after cTME (median 10; range 0-17). No significant difference was found in end colostomy rate between the two groups. Major 30-day morbidity (Clavien-Dindo≥ III) was 20 and 32%, respectively (p = 0.321). Hospital stay was significantly longer after cTME. CONCLUSION: TaTME after full-thickness excision is a promising technique with a significantly lower risk of perforation of the rectum and better specimen quality compared to conventional completion TME.

Residual mesorectum on postoperative magnetic resonance imaging following transanal total mesorectal excision (TaTME) and laparoscopic total mesorectal excision (LapTME) in rectal cancer.

BACKGROUND: The standard treatment for mid- and low-rectal cancer is total mesorectal excision. Incomplete excision is an important predictor of local recurrence after rectal cancer surgery. Transanal TME (TaTME) is a new treatment option in which the rectum is approached with both laparoscopic and transanal endoscopic techniques. The aim of the present study was to determine the prevalence and localisation of residual mesorectal tissue by postoperative magnetic resonance imaging (MRI) of the pelvis and compare this between TaTME and laparoscopic TME (LapTME) patients. In addition, we assessed correspondence with histopathological quality. METHODS: Two groups of patients with cT1-T3 rectal cancer who underwent TME surgery with primary anastomosis were included, each group consisting of 32 patients. Postoperative T2-weighted MRI of the pelvis was performed at least 6 months after TME surgery and evaluated by two radiologists independently. Residual mesorectum was defined as any residual mesorectal tissue detectable after TME. Localisation of the tissue was categorised in relation to height in the pelvis and position of the level of anastomosis. RESULTS: Residual mesorectal tissue was detected in 3.1% of TaTME patients and of 46.9% in LapTME patients (p < 0.001). Multivariate analysis identified only type of surgery as a significant risk factor for leaving residual mesorectum. Other known risk factors for incomplete TME, such as body mass index (BMI) and male gender, were not significant. No relation was seen between specimen quality and prevalence of residual mesorectum. CONCLUSIONS: The completeness of mesorectal excision was significantly better with TaTME than with standard laparoscopic technique.

Transanal total mesorectal excision for rectal cancer: evaluation of the learning curve.

BACKGROUND: Transanal total mesorectal excision (TaTME) provides an excellent view of the resection margins for rectal cancer from below, but is challenging due to few anatomical landmarks. During implementation of this technique, patient safety and optimal outcomes need to be ensured. The aim of this study was to evaluate the learning curve of TaTME in patients with rectal cancer in order to optimize future training programs. METHODS: All consecutive patients after TaTME for rectal cancer between February 2012 and January 2017 were included in a single-center database. Influence of surgical experience on major postoperative complications, leakage rate and operating time was evaluated using cumulative sum charts and the splitting model. Correction for potential case-mix differences was performed. RESULTS: Over a period of 60 months, a total of 138 patients were included in this study. Adjusted for case-mix, improvement in postoperative outcomes was clearly seen after the first 40 patients, showing a decrease in major postoperative complications from 47.5 to 17.5% and leakage rate from 27.5 to 5%. Mean operating time (42 min) and conversion rate (from 10% to zero) was lower after transition to a two-team approach, but neither endpoint decreased with experience. Readmission and reoperation rates were not influenced by surgical experience. CONCLUSIONS: The learning curve of TaTME affected major (surgical) postoperative complications for the first 40 patients. A two-team approach decreased operative time and conversion rate. When implementing this new technique, a thorough teaching and supervisory program is recommended to shorten the learning curve and improve the clinical outcomes of the first patients.

Transanal total mesorectal excision (TaTME) for rectal cancer: effects on patient-reported quality of life and functional outcome.

BACKGROUND: Transanal total mesorectal excision (TaTME) has rapidly become an important component of the treatment of rectal cancer surgery. Cohort studies have shown feasibility concerning procedure, specimen quality and morbidity. However, concerns exist about quality of life and ano(neo)rectal function. The aim of this study was to prospectively evaluate quality of life in patients following TaTME for rectal cancer with anastomosis. METHODS: Consecutive patients who underwent restorative TaTME surgery for rectal adenocarcinoma in an academic teaching center with tertiary referral function were evaluated. Validated questionnaires were prospectively collected. Quality of life was assessed by the EuroQol 5D (EQ-5D), European Organization for Research and Treatment of Cancer's QLQ-C30 and QLQ-CR29 and low anterior resection syndrome (LARS) scale. Outcomes of the questionnaires at 1 and 6 months were compared with preoperative (baseline) values. RESULTS: Thirty patients after restorative TaTME for rectal cancer were included. Deterioration for all domains was mainly observed at 1 month after surgery compared to baseline, but most outcomes had returned to baseline at 6 months. Social function and anal pain remained significantly worse at 6 months. Major LARS (score >30) was 33% at 6 months after ileostomy closure. No end colostomies were required. CONCLUSIONS: TaTME is associated with acceptable quality of life and functional outcome at 6 months after surgery comparable to published results after conventional laparoscopic low anterior resection.

ECSPECT prospective multicentre registry for single-port laparoscopic colorectal procedures.

BACKGROUND: The international multicentre registry ECSPECT (European Consensus of Single Port Expertise in Colorectal Treatment) was established to evaluate the general feasibility and safety of single-port colorectal surgery with regard to preoperative risk assessment. METHODS: Consecutive patients undergoing single-port colorectal surgery were enrolled from 11 European centres between March 2010 and March 2014. Data were analysed to assess patient-, technique- and procedure-dependent parameters. A validated sex-adjusted risk chart was developed for prediction of single-port colorectal surgery-related conversion and complications. RESULTS: Some 1769 patients were enrolled, 937 with benign and 832 with malignant conditions. Procedures were completed without additional trocars in 1628 patients (92·0 per cent). Conversion to open surgery was required in 75 patients (4·2 per cent) and was related to male sex and ASA fitness grade exceeding I. Conversions were more frequent in pelvic procedures involving the rectum compared with abdominal procedures (8·1 versus 3·2 per cent; odds ratio 2·69, P < 0·001). Postoperative complications were observed in a total of 224 patients (12·7 per cent). Independent predictors of complications included male sex (P < 0·001), higher ASA grade (P = 0·006) and rectal procedures (P = 0·002). The overall 30-day mortality rate was 0·5 per cent (8 of 1769 patients); three deaths (0·2 per cent; 1 blood loss, 2 leaks) were attributable to surgical causes. CONCLUSION: The feasibility and safety, conversion and complication profile demonstrated here provides guidance for patient selection.

Clinical outcomes and case volume effect of transanal total mesorectal excision for rectal cancer: a systematic review.

Transanal total mesorectal excision (TaTME) has been developed to improve quality of TME for patients with mid and low rectal cancer. However, despite enthusiastic uptake and teaching facilities, concern exists for safe introduction. TaTME is a complex procedure and potentially a learning curve will hamper clinical outcome. With this systematic review, we aim to provide data regarding morbidity and safety of TaTME. A systematic literature search was performed in MEDLINE (PubMed), EMBASE (Ovid) and Cochrane Library. Case reports, cohort series and comparative series on TaTME for rectal cancer were included. To evaluate a potential effect of case volume, low-volume centres (n ≤ 30 total volume) were compared with high-volume centres (n > 30 total volume). Thirty-three studies were identified (three case reports, 25 case series, five comparative studies), including 794 patients. Conversion was performed in 3.0% of the procedures. The complication rate was 40.3, and 11.5% were major complications. The quality of the mesorectum was "complete" in 87.6%, and the circumferential resection margin (CRM) was involved in 4.7%. In low- versus high-volume centres, the conversion rate was 4.3 versus 2.7%, and major complication rates were 12.2 versus 10.5%, respectively. TME quality was "complete" in 80.5 versus 89.7%, and CRM involvement was 4.8 and 4.5% in low- versus high-volume centres, respectively. TaTME for mid and low rectal cancer is a promising technique; however, it is associated with considerable morbidity. Safe implementation of the TaTME should include proctoring and quality assurance preferably within a trial setting.

A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer.

BACKGROUND: Rectal cancer surgery is accompanied with high morbidity and poor long term functional outcome. Screening programs have shown a shift towards more early staged cancers. Patients with early rectal cancer can potentially benefit significantly from rectal preserving therapy. For the earliest stage cancers, local excision is sufficient when the risk of lymph node disease and subsequent recurrence is below 5 %. However, the majority of early cancers are associated with an intermediate risk of lymph node involvement (5-20 %) suggesting that local excision alone is not sufficient, while completion radical surgery, which is currently standard of care, could be a substantial overtreatment for this group of patients. METHODS/STUDY DESIGN: In this multicentre randomised trial, patients with an intermediate risk T1-2 rectal cancer, that has been locally excised using an endoluminal technique, will be randomized between adjuvant chemo-radiotherapylimited to the mesorectum and standard completion total mesorectal excision (TME). To strictly monitor the risk of locoregional recurrence in the experimental arm and enable early salvage surgery, there will be additional follow up with frequent MRI and endoscopy. The primary outcome of the study is three-year local recurrence rate. Secondary outcomes are morbidity, disease free and overall survival, stoma rate, functional outcomes, health related quality of life and costs. The design is a non inferiority study with a total sample size of 302 patients. DISCUSSION: The results of the TESAR trial will potentially demonstrate that adjuvant chemoradiotherapy is an oncological safe treatment option in patients who are confronted with the difficult clinical dilemma of a radically removed intermediate risk early rectal cancer by polypectomy or transanal surgery that is conventionally treated with subsequent radical surgery. Preserving the rectum using adjuvant radiotherapy is expected to significantly improve morbidity, function and quality of life if compared to completion TME surgery. TRIAL REGISTRATION: NCT02371304 , registration date: February 2015.

Neoadjuvant chemotherapy in breast-conserving surgery - Consequences on margin status and excision volumes: A nationwide pathology study.

BACKGROUND: Neoadjuvant chemotherapy (NACT) is increasingly used in patients with operable disease due to the potential of converting patients requiring mastectomy to breast conserving surgery (BCS) or lowering resection volumes to improve cosmetic outcome. This nationwide retrospective study aims to determine margin status and specimen volume in patients with invasive breast cancer who underwent BCS after NACT. METHODS: All patients who underwent BCS in 2012-2013 for invasive breast cancer were selected from a nationwide network and registry of histology and cytopathology in the Netherlands (PALGA). RESULTS: Of the 9901 patients, 626 (6.3%) received NACT. After primary surgery 949 (10.2%) patients had tumour-involved margins compared to 152 (24.3%) after NACT. Close margins (≤1 mm) were seen in another 111 (17.7%) patients after NACT. The adjusted odds ratio for involved margins after NACT was 2.94, meaning a three times higher risk of involved margins compared with primary surgery. In patients with lobular carcinoma (54.9%) and no response to NACT (42.1%) higher tumour-involved margins were seen. High resection volumes >60 cc were observed in 224 (36%) patients after NACT of which 37 (16.5%) had tumour involved margins and 32 (14.3%) close margins ≤1 mm. CONCLUSION: The primary goal of the surgeon performing BCS after NACT, to reach tumour-free margins, is not accomplished in one out of four patients. Patients especially at risk are patients with ILC and no pathological tumour response. Excessive resection volumes after NACT do not guarantee tumour-free margins. Further research is necessary to analyze whether we are counterproductive when NACT is given in order to lower resection volumes.

A nationwide pathology study on surgical margins and excision volumes after breast-conserving surgery: There is still much to be gained.

AIM OF THE STUDY: The current study aims to assess margin status in relation to amount of healthy breast tissue resected in breast-conserving surgery (BCS) on a nationwide scale. METHODS: Using PALGA (a nationwide network and registry of histology and cytopathology in the Netherlands), all patients who underwent BCS for primary invasive carcinoma in 2012-13 were selected (10,058 excerpts). 9276 pathology excerpts were analyzed for a range of criteria including oncological margin status and distance to closest margin, specimen weight/volume, greatest tumor diameter, and with or without localization method. Calculated resection ratios (CRR) were assessed to determine excess healthy breast tissue resection. RESULTS: Margins for invasive carcinoma and in situ carcinoma combined were tumor-involved in 498 (5.4%) and focally involved in 1021 cases (11.0%) of cases. Unsatisfactory resections including (focally) involved margins and margins ≤ 1 mm were reported in 33.8% of patients. The median lumpectomy volume was 46 cc (range 1-807 cc; SD 49.18) and median CRR 2.32 (range 0.10-104.17; SD 3.23), indicating the excision of 2.3 the optimal resection volume. CONCLUSION: The unacceptable rate of tumor-involved margins as well as margins ≤ 1 mm in one third of all patients is also achieved at the expense of healthy breast tissue resection, which may carry the drawback of high rates of cosmetic failure. These data clearly suggest the need for improvement in current breast conserving surgical procedures to decrease tumor-involved margin rates while reducing the amount of healthy breast tissue resected.

Transanal total mesorectal excision for rectal carcinoma: short-term outcomes and experience after 80 cases.

BACKGROUND: Low anterior resection for distal and mid-rectal cancer is associated with high positive resection margins. Transanal total mesorectal excision (TaTME) is a new treatment in which the rectum is dissected transanally according to TME principles. The short-term results and oncological follow-up of the first 80 patients were described. METHODS: Between June 2012 and September 2014, all patients in the Gelderse Vallei Hospital and the VU University Medical Center with histologically proven distal or mid-rectal carcinomas without evidence of distant metastases underwent TaTME. Patients with T4 tumors were excluded. Transanal mobilization was performed with the aid of a single port and endoscopic instruments according to TME criteria. RESULTS: Eighty patients were operated in a period of 2 years. Laparotomy was recommended and performed in four patients. Postoperative morbidity was 39%. Ten (12%) complications were graded as severe (Clavien-Dindo grade 3, 4 and 5) and needed re-intervention. Median operative time was 204 min (range 91-447). Median hospital stay was 8 days (range 3-41). Specimens were graded as complete in 88% of the patients, nearly complete in 9% and incomplete in 3%. A positive circumferential resection margin (<2 mm) was observed in two patients. During the two and half years study period, a local recurrence was observed in two patients. CONCLUSION: TaTME is a safe alternative to standard laparoscopic TME in selected low-risk patients with rectal carcinoma when treated by an experienced colorectal team. In the future, randomized trials are necessary to prove its oncological safety.

Improved quality of care for patients undergoing an abdominoperineal excision for rectal cancer.

INTRODUCTION: New diagnostics, the emergence of total mesorectal excision and neoadjuvant treatments have improved outcome for patients with rectal cancer. Patients with distal rectal cancer undergoing an abdominoperineal excision seem to do worse compared to those treated with sphinctersparing techniques. The aim of this study was to evaluate the quality of care for patients undergoing an abdominoperineal excision for distal rectal cancer during the last 15 years. MATERIALS AND METHODS: All patients with rectal cancer, who underwent an abdominoperineal excision between December 1996 and December 2010 in 5 Dutch hospitals were analysed. Patients were divided into three cohorts; 1996-2001, 2001-2005 and 2006-2010. All data was extracted from medical records. RESULTS: 477 patients were identified. There was no significant difference in sex, age, BMI, prior pelvic surgery and ASA stages between the cohorts. MRI became a standard tool in the work-up, the use increased from 4.5% in the first, to 95.1% in the last cohort (p < 0.0001). Neoadjuvant treatment shifted from predominantly none (64.9% in cohort 1) to short course radiotherapy (66.7% in cohort 2) and chemoradiation therapy (55.7% in cohort 3). There was a trend towards a decreased circumferential resection margin involvement in the cohorts (18.8%, 16.7% and 11.4%; p = 0.142). Accidental bowel perforations have significantly decreased from 28.6%, and 21.7% to 9.2% in cohort 3 (p < 0.0001). CONCLUSION: Significant improvements in work-up, neoadjuvant and surgical treatment have been made for patients with low rectal cancer, undergoing an abdominoperineal excision. These improvements result in improved short term outcome.

Feasibility study of transanal total mesorectal excision.

BACKGROUND: Laparoscopic resection of colorectal cancers is a safe alternative to open surgery. The conversion rate to open surgery remains fairly constant but is associated with increased morbidity. A new approach to the surgical excision of rectal cancer is transanal total mesorectal excision (TME), in which the rectum is mobilized peranally using endoscopic instruments. This feasibility study describes initial results with transanal TME. METHODS: Between June and August 2012, five consecutive unselected patients with rectal carcinoma underwent surgical excision of rectal tumours by means of transanal TME. RESULTS: Transanal endoscopic dissection of the complete rectum was possible in all patients. Histopathological examination confirmed clear surgical margins and an intact mesorectal fascia in all patients. One patient developed a presacral abscess. Median duration of operation was 175 (range 160-194) min. CONCLUSION: Transanal TME using the down-to-up principle is feasible. Whether the oncological and clinical results are comparable with those of standard laparoscopic or open TME has yet to be proven.