Total Mesorectal Excision In Patients Research Articles

A study of intersphincteric resection rate following robotic-assisted total mesorectal excision versus laparoscopic-assisted total mesorectal excision for patients with middle and low rectal cancer: study protocol for a multicenter randomized clinical trial

IntroductionRobotic-assisted complete mesorectal excision (RATME) is increasingly being used by colorectal surgeons. Most surgeons consider RATME a safe method, and believe it can facilitate total mesorectal excision (TME) in rectal cancer, and may potentially have advantages over intersphincteric resection (ISR) and anus preservation. Therefore, this trial was designed to investigate whether RATME has technical advantages and can increase the ISR rate compared with laparoscopic-assisted TME (LATME) in patients with middle and low rectal cancer.Methods and analysisThis is a multicenter, superiority, randomized controlled trial designed to compare RATME and LATME in middle and low rectal cancer. The primary endpoint is the ISR rate. The secondary endpoints are coloanal anastomosis (CAA) rate, conversion to open surgery, conversion to transanal TME (TaTME), abdominoperineal resection (APR) rate, postoperative morbidity and mortality within 30 days, pathological outcomes, long-term survival outcomes, functional outcomes, and quality of life. In addition, certain measurements will be conducted to ensure quality and safety, including centralized photography review and semiannual assessment.DiscussionThis trial will clarify if RATME improves ISR and promotes anus preservation in patients with mid- and low-rectal cancer. Furthermore, this trial will provide evidence on the optimal treatment strategies for RATME and LATME in patients with mid- and low-rectal cancer regarding improved operational safety.Trial registrationClinicalTrials.gov NCT06105203. Registered on October 27, 2023.

Management of Locally Advanced Rectal Cancer: ASCO Guideline.

ASCO Guidelines provide recommendations with comprehensive review and analyses of the relevant literature for each recommendation, following the guideline development process as outlined in the ASCO Guidelines Methodology Manual. ASCO Guidelines follow the ASCO Conflict of Interest Policy for Clinical Practice Guidelines.Clinical Practice Guidelines and other guidance ("Guidance") provided by ASCO is not a comprehensive or definitive guide to treatment options. It is intended for voluntary use by providers and should be used in conjunction with independent professional judgment. Guidance may not be applicable to all patients, interventions, diseases or stages of diseases. Guidance is based on review and analysis of relevant literature, and is not intended as a statement of the standard of care. ASCO does not endorse third-party drugs, devices, services, or therapies and assumes no responsibility for any harm arising from or related to the use of this information. See complete disclaimer in Appendix 1 and 2 (online only) for more.PURPOSETo provide evidence-based guidance for clinicians who treat patients with locally advanced rectal cancer.METHODSA systematic review of the literature published from 2013 to 2023 was conducted to identify relevant systematic reviews, phase II and III randomized controlled trials (RCTs), and observational studies where applicable.RESULTSTwelve RCTs, two systematic reviews, and one nonrandomized study met the inclusion criteria for this systematic review. Expert Panel members used available evidence and informal consensus to develop evidence-based guideline recommendations.RECOMMENDATIONSFollowing assessment with magnetic resonance imaging, for patients with microsatellite stable or proficient mismatch repair locally advanced rectal cancer, total neoadjuvant therapy (TNT; ie chemoradiation [CRT] and chemotherapy) should be offered as initial treatment for patients with tumors located in the lower rectum and/or patients who are at higher risk for local and/or distant metastases. Patients without higher-risk factors may discuss chemotherapy with selective CRT depending on extent of response, TNT, or neoadjuvant long-course CRT or short-course radiation. For patients who are candidates for TNT, the preferred timing for chemotherapy is after radiation, and neoadjuvant long-course CRT is preferred over short-course radiation therapy (RT), however short-course RT may also be a viable treatment option depending on circumstances. Nonoperative management may be discussed as an alternative to total mesorectal excision for patients who have a clinical complete response to neoadjuvant therapy. For patients whose tumors are microsatellite instability-high or mismatch repair deficient, immunotherapy is recommended.Additional information is available at http://www.asco.org/gastrointestinal-cancer-guidelines.

Peri-operative, oncological and functional outcomes of robotic versus transanal total mesorectal excision in patients with rectal cancer: A systematic review and meta-analysis.

Comparative outcomes of robotic low anterior resection (rTME) and trans-anal total mesorectal excision (TaTME) in patients with low rectal cancer were evaluated. A systematic online search was conducted using the following databases: PubMed, Scopus, Cochrane database, The Virtual Health Library, Clinical trials.gov and Science Direct. Comparative studies of rTME versus TaTME for low rectal cancer were included. Primary outcomes were postoperative complications, including anastomotic leak, surgical site infection, and Clavien-Dindo complication rate. Total operative time, conversion to open surgery, intra-operative blood loss, intensive therapy unit (ITU) and total hospital length of stay (LOS), oncological outcomes and functional outcomes were the other evaluated outcome parameters. A total of 12 studies with a total number of 3025 patients divided between rTME (n = 1881) and TaTME (n = 1144) groups were included. There was no significant difference between the two groups for total operative time (P = 0.39), conversion to open surgery (P = 0.29) and intra-operative blood loss (P = 0.62). Clavien-Dindo ≥ 3 complication rate (P = 0.47), anastomotic leak (P = 0.89), rates of re-operation (P = 0.62) and re-admission (P = 0.92), R0 resections (P = 0.52), ITU LOS (P = 0.63) and total hospital LOS (P = 0.30) also showed similar results between the two groups. However, the rTME group had higher rates of total harvested lymph nodes (P = 0.04) and complete total mesorectal excision (TME) resections (P = 0.05). Albeit with a limited dataset, the Wexner and low anterior resection syndrome (LARS) scores showed better functional results in the rTME group compared with the TaTME group (P = 0.0009 and P = 0.00001, respectively). Compared with TaTME, rTME seems to provide better functional outcomes, higher lymph node yield and more complete TME resections with a similar post-operative complications profile.

Surgical effect and gastrointestinal functional recovery of laparoscopic-guided total mesorectal excision in patients with rectal cancer.

To explore the surgical effect and gastrointestinal functional recovery of laparoscopic-guided total mesorectal excision (LGTME) in patients with rectal cancer. A total of 150 rectal cancer patients who underwent surgical treatment in our hospital from July 2022 to July 2023 were selected and randomly divided into two groups using a random number table. There were 75 cases in the control group (CG) who underwent traditional open rectal total mesorectal excision surgery and 75 cases in the experimental group (EG) who underwent LGTME. The surgical effects of the two groups were compared, and the gastrointestinal and anal functional recovery of the two groups were compared before and after treatment. Intraoperative bleeding, incision length, time to initial feeding and time to anal exhaust in the EG were significantly lower than those in the CG ( P < 0.05). Before treatment, there was no significant difference in gastrointestinal function and anal function between the two groups ( P > 0.05). After treatment, the levels of motilin, gastrin, neuropeptide Y and basic fibroblast growth factor in the EG were significantly higher than those in the CG, with statistical significance ( P < 0.05); the maximum anal systolic pressure and resting anal sphincter pressure in the EG were significantly lower than those in the CG ( P < 0.05); the rectal sensitivity threshold volume (RSTV) and rectal maximum volume threshold in the EG were significantly higher than those in the CG ( P < 0.05). There was no significant difference in most postoperative complications between the two groups ( P > 0.05). LGTME improves the surgical effects of rectal cancer patients, promotes the recovery of gastrointestinal function and has a small effect on anal function indicators, thereby reducing hospital stay.

SP5.5 Peri-operative, Oncological and Functional Outcomes of Robotic versus Transanal Total Mesorectal Excision in patients with Rectal Cancer: A Systematic Review and Meta-analysis

Abstract Background To evaluate comparative outcomes of robotic low anterior resection (RTME) and spinal Trans-anal total mesorectal excision (TaTME) in patients with low rectal cancer. Methods A systematic online search was conducted using the following databases: PubMed, Scopus, Cochrane database, The Virtual Health Library, Clinical trials.gov and Science Direct. Comparative studies comparing RTME versus TaTME for low rectal cancer were included. Primary outcomes were post-operative complications namely, anastomosis leak, SSI, overall complications rate, and Clavien-Dindo complications rate. Operative time, conversion to open, Intra-operative blood loss, ITU and hospital length of stay (LOS), post-operative complications, oncological outcomes, and functional outcomes were the evaluated outcome parameters. Results Twelve studies with a total number of 3025 patients divided between the Robotic group (n=1881) and TaTME group (n=1144) were included. There was a significant difference between the two groups regarding Operative time (P=0.39), conversion to open (P=0.29) and intra-operative blood loss (P= 0.62). Clavien-Dindo ≥ 3 complications rate (P=0.25), anastomosis leak (P= 0.89), re-operation (P=0.62), re-admission rate (P=0.92), R0 resection (P= 0.52), ITU LOS (P= 0.63) and total LOS (P=0.30) showed similar results between the two groups. RTME group showed a higher rate of harvested lymph nodes (P= 0.04) and completed TME (P=0.05). Wexner and LARS scores showed significantly better functional results in the RTME group compared to the TaTME group (P= 0.0009) and (P= 0.00001), respectively. Conclusion Compared to TaTME, RTME provides significantly better functional outcomes, a higher number of harvested lymph and complete TME with a similar postoperative complications rate.

Outcomes of extended total mesorectal excision in patients with locally advanced rectal cancer.

Extended total mesorectal excision (eTME) is a complex procedure involving en bloc resection of the structures surrounding the various quadrants of the rectum. This study, presenting the largest series so far of patients undergoing eTME, aimed to assess the surgical and survival outcomes of patients following treatment with eTME and to compare these outcomes with historical data on pelvic exenteration. The study is a retrospective review of all patients with locally advanced rectal cancer requiring an eTME (2014-2020). The database includes the demographic profile, operative details, histopathological features and follow-up. One hundred and sixty three patients who underwent eTME were analysed. The overall Clavien-Dindo complication rate of > IIIa was 21.1%. The anterior quadrant was the most common anatomical site resected (68.5%). The R1 resection rate was 10.4%. After a median follow-up of 28 months, there were 51 recurrences in the study and twenty two deaths were recorded. The local recurrence rate was 7.3% among the study population. The disease-free survival (DFS) and overall survival were 66.7% and 80.4%, respectively, at 3 years. The majority of the recurrences were distant metastasis (84.3%). In univariate analysis, the quadrant involved did not affect survival. In multivariate analysis, signet ring histology, metastatic presentation, inadequate tumour response and R1 resection affected DFS. The recurrence pattern, R1 resection rate and survival outcomes of patients in the present study were comparable with those for patients undergoing an exenteration. Therefore, eTME is probably a safe alternative to pelvic exenterations when R0 resection is achievable and when the procedure is performed in high-volume specialist tertiary care centres.

Cost analysis and cost-effectiveness of open versus laparoscopic versus robot-assisted versus transanal total mesorectal excision in patients with rectal cancer: a protocol for a systematic review

IntroductionNowadays, most rectal tumours are treated open or minimally invasive, using laparoscopic, robot-assisted or transanal total mesorectal excision. However, insight into the total costs of these techniques is limited. Since...

Cost-effectiveness of Total Neoadjuvant Therapy With Short-Course Radiotherapy for Resectable Locally Advanced Rectal Cancer

Short-course radiotherapy and total neoadjuvant therapy (SCRT-TNT) followed by total mesorectal excision (TME) has emerged as a new treatment paradigm for patients with locally advanced rectal adenocarcinoma. However, the economic implication of this treatment strategy has not been compared with that of conventional long-course chemoradiotherapy (LCCRT) followed by TME with adjuvant chemotherapy. To perform a cost-effectiveness analysis of SCRT-TNT vs LCCRT in conjunction with TME for patients with locally advanced rectal cancer. A decision analytical model with a 5-year time horizon was constructed for patients with biopsy-proven, newly diagnosed, primary locally advanced rectal adenocarcinoma treated with SCRT-TNT or LCCRT. Markov modeling was used to model disease progression and patient survival after treatment in 3-month cycles. Data on probabilities and utilities were extracted from the literature. Costs were evaluated from the Medicare payer's perspective in 2020 US dollars. Sensitivity analyses were performed for key variables. Data were collected from October 3, 2020, to January 20, 2021, and analyzed from November 15, 2020, to April 25, 2021. Two treatment strategies, SCRT-TNT vs LCCRT with adjuvant chemotherapy, were compared. Cost-effectiveness was evaluated using the incremental cost-effectiveness ratio and net monetary benefits. Effectiveness was defined as quality-adjusted life-years (QALYs). Both costs and QALYs were discounted at 3% annually. Willingness-to-pay threshold was set at $50 000/QALY. During the 5-year horizon, the total cost was $41 355 and QALYs were 2.21 for SCRT-TNT; for LCCRT, the total cost was $54 827 and QALYs were 2.12, resulting in a negative incremental cost-effectiveness ratio (-$141 256.77). The net monetary benefit was $69 300 for SCRT-TNT and $51 060 for LCCRT. Sensitivity analyses using willingness to pay at $100 000/QALY and $150 000/QALY demonstrated the same conclusion. These findings suggest that SCRT-TNT followed by TME incurs lower cost and improved QALYs compared with conventional LCCRT followed by TME and adjuvant chemotherapy. These data offer further rationale to support SCRT-TNT as a novel cost-saving treatment paradigm in the management of locally advanced rectal cancer.

The double bipolar method for robotic total mesorectal excision in patients with rectal cancer

Although meta-analyses and systematic reviews have clarified the benefits of robotic surgery, few studies have focused on robotic rectal surgery (RRS) and the use of Endowrist® instruments. Therefore, we evaluated RRS using the double bipolar method (DBM) and compared its short-term outcomes with those of RRS using the single bipolar method (SBM). This study enrolled 157 consecutive patients and all procedures were performed by the same surgeon and recorded through short video clips. We analyzed the patient demographics and short-term clinical outcomes. Although this observational study has several limitations, the console time for total mesorectal excision using the DBM was significantly shorter than that using the SBM. Although the DBM did not demonstrate a specific learning curve, it was a safe and feasible procedure even for patients with advanced disease. Further studies are needed to evaluate the cost-effectiveness of the DBM.

Cost-Effectiveness of TME Alone vs. Neoadjuvant Chemoradiotherapy for Stage II and III Rectal Cancer

<h3>Purpose/Objective(s)</h3> The role of neoadjuvant chemoradiotherapy in rectal cancer is rapidly evolving. Neoadjuvant chemoradiotherapy (nCRT) reduces the risk of local recurrence in rectal cancer patients, but is associated with increased adverse events, costs, and prolonged treatment time. Pre-operative risk stratification of patients into low- and high-risk categories for local recurrence may identify populations that benefit from nCRT, despite these additional costs. Although total mesorectal excision (TME) alone and nCRT with TME (nCRT/TME) are both in clinical practice, no cost-effectiveness analysis comparing these two treatment approaches in rectal cancer has been published. We sought to determine the cost-effectiveness of primary TME versus nCRT with TME for patients with rectal cancer. <h3>Materials/Methods</h3> We developed a Markov model to simulate the 3-year outcomes of 1 million hypothetical patients as treated on the OCUM trial (NCT 325649) with histologically confirmed invasive carcinoma of the rectum (cT2 to cT4, mC0) with distal tumor margin less than 16 cm from the anal verge undergoing either primary TME or nCRT followed by TME. To calculate the incremental cost-effectiveness ratios, we used utilities and probabilities from the literature and costs from Medicare fee schedules and the Healthcare Bluebook. We discounted utilities and costs at 3% annually. Willingness to pay (WTP) was defined at ICER of $100 000 or less per quality-adjusted life-year (QALY). 1-way sensitivity analyses were performed varying selective model inputs to account for uncertainty. Probabilistic sensitivity analysis (PSA) was conducted. <h3>Results</h3> TME was the dominant strategy compared with nCRT and TME (incremental cost-effectiveness ratio, -$158,201.86/QALY). TME and nCRT/TME were associated with costs of $32,518 and $70,583 and QALYs of 1.91 and 1.67, respectively. TME remained the dominant strategy across all 1-way sensitivity analyses in cost, utility states, and probabilities with the exception of the utilities of the health states post-TME and post-nCRT/TME. When the utility of TME treatment fell below 0.4, nCRT/TME became the dominant strategy. Conversely, when the utility of nCRT/TME treatment rose above 0.69 (.1 above the baseline TME utility), nCRT/TME became the dominant strategy. PSA with 1,000,000 samples revealed TME was the cost-effective strategy in 67.4% of trials. <h3>Conclusion</h3> In patients with rectal cancer, TME was the cost-effective strategy compared with nCRT/TME. TME remained the cost-effective strategy across a range of tested variations in cost, probabilities, and utilities but was sensitive to the utility of TME and nCRT/TME. The results of this study contribute to the growing body of literature decreasing usage of nCRT/TME for patients with rectal cancer, particularly if they have low risk of local recurrence.

A study on the clinical application of greater omental pedicle flap transplantation to correct anterior resection syndrome in patients with low rectal cancer.

IntroductionLow anterior resection syndrome (LARS) is the most common complication after total mesorectal excision (TME) in patients with low rectal cancer and has been a challenge in colorectal surgery that severely impacts the quality of life of patients. This study aimed to introduce a revised surgical procedure which could effectively maintain rectal compliance and significantly improve LARS after the operation.MethodsWe performed mesorectal reconstruction after routine Dixon TME using greater omental pedicle flap transplantation in 11 patients with low rectal cancer (5 cases of preoperative neoadjuvant chemoradiotherapy, 5 cases of preoperative neoadjuvant chemotherapy, and 1 case of postoperative adjuvant chemotherapy), thereby simulating the initial anatomical structure of the mesorectum and significantly reducing the postoperative anterior resection syndrome. The lars precision syndrome assessment scale (LARSS) was used to access the LARS.ResultsAt 12 weeks after the 11 patients recovered from the anal defecation function, the average score on the LARS questionnaire was 25.5 ± 1.5 (minor). The average time at which anal function began to recover was 6.2 ± 2.6 weeks after surgery. The recovery was rapid, as the rectal and anal function of all patients generally returned to normal levels within 12 weeks, and the quality of life was close to that before surgery.ConclusionGreater omental flap transplantation can significantly improve LARS after Dixon TME in patients with low rectal cancer.

Optimal Size Criteria for Lateral Lymph Node Dissection After Neoadjuvant Chemoradiotherapy for Rectal Cancer.

Although chemoradiotherapy followed by radical surgery without lateral lymph node dissection is the current standard treatment in patients with rectal cancer, recent studies have demonstrated the benefits of adding lateral lymph node dissection to total mesorectal excision in patients with suspected lateral lymph node metastasis. However, the optimal indication for lateral lymph node dissection after chemoradiotherapy has not been determined. This study aimed to establish the optimal indication for lateral lymph node dissection after chemoradiotherapy in patients with rectal cancer. This is a retrospective study. This study was conducted at a single referral hospital. A total of 279 patients with rectal cancer who underwent chemoradiotherapy followed by radical surgery between 2007 and 2018 were retrospectively enrolled. The largest lateral lymph nodes on CT were retrospectively assessed and compared with the pathologic results of dissected lateral lymph nodes and recurrences in lateral lymph node areas. The incidence of lateral lymph node metastasis after chemoradiotherapy was estimated to be 9.3%. Although patients with lateral lymph node metastasis frequently developed distant recurrence, 40.4% survived for >5 years without recurrence. An analysis of the lateral lymph node sizes showed that lateral lymph node size ≥8 mm before chemoradiotherapy was the optimal criterion for lateral lymph node dissection, with a sensitivity and specificity of 92.3% and 78.7%. Using this criterion, 72.0% of the patients could be spared lateral lymph node dissection. Because of the retrospective nature of the present study, the selection of patients who underwent lateral lymph node dissection was biased. The optimal indication for lateral lymph node dissection was lateral lymph node size ≥8 mm before chemoradiotherapy. Cancer could be eradicated in >30% of patients with lateral lymph node metastasis by dissecting metastatic lateral lymph nodes. See Video Abstract at http://links.lww.com/DCR/B428. ANTECEDENTES:Aunque la quimiorradioterapia seguida por cirugía radical sin disección de ganglios linfáticos laterales es el tratamiento estándar actual en pacientes con cáncer de recto, estudios recientes han demostrado beneficios de agregar disección de ganglios linfáticos laterales a la escisión mesorrectal total en pacientes con sospecha de metástasis de ganglios linfáticos laterales. Sin embargo, no se ha determinado la indicación óptima para la disección de los ganglios linfáticos laterales después de la quimiorradioterapia.OBJETIVO:Este estudio tuvo como objetivo establecer la indicación óptima para la disección de los ganglios linfáticos laterales después de la quimiorradioterapia en pacientes con cáncer de recto.DISEÑO:Estudio retrospectivo.ENTORNO CLINICO:Este estudio se realizó en un solo hospital de referencia.PACIENTES:Se inscribieron retrospectivamente un total de 279 pacientes con cáncer de recto que se sometieron a quimiorradioterapia seguida por cirugía radical entre 2007 y 2018.PRINCIPALES MEDIDAS DE VALORACION:Los ganglios linfáticos laterales más grandes en la tomografía computarizada se evaluaron retrospectivamente y se compararon con los resultados patológicos de los ganglios linfáticos laterales disecados y recidivas en las áreas de los ganglios linfáticos laterales.RESULTADOS:Se estimó que la incidencia de metástasis en los ganglios linfáticos laterales después de la quimiorradioterapia fue del 9,3%. Aunque los pacientes con metástasis en los ganglios linfáticos laterales con frecuencia desarrollaron recurrencia a distancia, el 40,4% sobrevivió durante más de 5 años sin recurrencia. Un análisis de los tamaños de los ganglios linfáticos laterales mostró que la mayor dimensión de los ganglios linfáticos laterales ≥ 8 mm antes de la quimiorradioterapia eran el criterio óptimo para la disección de los ganglios linfáticos laterales, con una sensibilidad y especificidad del 92,3% y 78,7%, respectivamente. Utilizando este criterio, el 72,0% de los pacientes podría evitarse la disección de los ganglios linfáticos laterales.LIMITACIONES:Debido a la naturaleza retrospectiva del presente estudio, la selección de pacientes que fueron sometidos a disección de ganglios linfáticos laterales fue sesgada.CONCLUSIÓN:La indicación óptima para la disección de los ganglios linfáticos laterales fue la dimensión mayor de los ganglios linfáticos laterales ≥ 8 mm antes de la quimiorradioterapia. El cáncer se podría erradicar en más del 30% de los pacientes con metástasis en los ganglios linfáticos laterales disecando los ganglios linfáticos laterales metastásicos. Consulte Video Resumen en http://links.lww.com/DCR/B428.

Long-Term Outcomes of Local Excision Following Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer

BackgroundLocal excision might represent an alternative to total mesorectal excision for patients with locally advanced rectal cancer who achieve a major or complete clinical response after neoadjuvant chemoradiotherapy.MethodsBetween August 2005 and July 2011, 63 patients with mid-low rectal adenocarcinoma who had a major/complete clinical response after neoadjuvant chemoradiotherapy were enrolled in a multicenter prospective phase 2 trial and underwent transanal full thickness local excision. The main endpoint of this study was to evaluate the 5- and 10-year overall, relapse-free, local, and distant relapse-free survival, which were calculated by applying the Kaplan–Meier method. The rate of patients with rectum preserved and without stoma were also calculated.ResultsOf 63 patients, 38 (60%) were male and 25 (40%) were female, with a median (range) age of 64 (25–82) years. At baseline, the following clinical stages were found: cT2, n = 21 (33.3%); cT3, n = 42 (66.6%), 39 (61.9%) patients were cN+. At a median (range) follow-up of 108 (32–166) months, the estimated cumulative 5- and 10-year overall survival, relapse-free survival, local recurrence-free survival, and distant recurrence-free survival were 87% (95% CI 76–93) and 79% (95% CI 66–87), 89% (95% CI 78–94) and 82% (95% CI 66–91), both 91% (95% CI 81–96), and 90% (95% CI 80–95) and 86% (95% CI 73–93), respectively. Overall, 49 (77.8%) patients had their rectum preserved, and 54 (84.1%) were stoma-free.ConclusionIn highly selected patients, the local excision approach after neoadjuvant chemoradiotherapy is associated with excellent long-term outcomes, high rates of rectum preservation and absence of permanent stoma.

NORAD01-GRECCAR16 multicenter phase III non-inferiority randomized trial comparing preoperative modified FOLFIRINOX without irradiation to radiochemotherapy for resectable locally advanced rectal cancer (intergroup FRENCH-GRECCAR- PRODIGE trial)

BackgroundPreoperative radiochemotherapy (RCT) is recommended in France prior to total mesorectal excision in patients with mid or low locally advanced rectal cancer (LARC) (cT3/T4 and/or N+) because it has been shown to improve local control. Preoperative RCT has also disadvantages including the absence of proven impact on metastatic recurrence and the risk of late side effects on bowel and genitourinary function. In patients with primarily resectable LARC, preoperative systemic chemotherapy without pelvic irradiation could be used as an alternative to RCT.MethodsThis study is a multicenter, open-label randomized, 2-arm phase III non-inferiority trial. Patients with mid or low resectable LARC (cT3N0 or cT1-T3N+ with circumferential resection margin [CRM] > 2 mm on pretreatment MRI) will be randomized to either modified FOLFIRINOX for 3 months or RCT (Cap50 intensified-modulated radiotherapy). All patients have restaging MRI after preoperative treatment. The primary endpoint is 3-year progression-free survival (PFS) from the time to randomization including progression during preoperative treatment. Secondary endpoints are treatment related toxicity, treatment compliance, R0 resection rate, sphincter saving surgery rate, postoperative morbidity and mortality rates, loco-regional recurrence free survival, overall survival, bowel and sexual functions at diagnosis, quality of life, radiologic and pathologic response after preoperative treatment. The number of patients required is 574.DiscussionThe choice of modified FOLFIRINOX for preoperative chemotherapy is supported by recent and consistent data on safety and efficacy of this regimen on rectal cancer. The use of preoperative chemotherapy instead of RCT could be associated with pronounced advantages in terms of functional results and quality of life in cancer survivors. However and first of all, the non-inferiority of preoperative chemotherapy compared to RCT on oncologic outcome has to be validated. If this study demonstrates the non-inferiority of chemotherapy compared to RCT, this can lead to a crucial change in clinical practice in a large subset of rectal cancer patients.Trial registrationClinicalTrials.gov NCT03875781 (March 15, 2019).Version 1.1.

Transanal Total Mesorectal Excision in Patients with Challenging Pelvis: A Comparative Study

Transanal Total Mesorectal Excision in Patients with Challenging Pelvis: A Comparative Study

Rectal cancer and pathologic complete response after preoperative chemoradiotherapy: Romanian single-center experience.

e15002 Background: Current guidelines recommend neoadjuvant chemoradiation followed by total mesorectal excision for patients with locally advanced rectal cancer (LARC). After neoadjuvant chemoradiation, some of these patients achieve a pathologic complete response (pCR) of the primary tumor (ypT0) and seem to have improved oncologic outcomes. In the last years, a "wait-and-watch"/active surveillance or less radical surgery was proposed for these patients. The aim of this study was to analyze the overall survival (OS), disease-free survival (DFS), various clinicopathological factors and treatment factors in patients with LARC and ypT0 treated in our institution. Methods: Patients with LARC who received neoadjuvant chemoradiotherapy and achieved ypT0 on the surgical specimen were included in the present study. Clinical, pathological and surgical data from 51 patients was retrospectively collected between 1st of January 2012 and 31st of December 2017. Kaplan-Meier method and multivariate analysis were used to investigate the role of various clinicopathological factors and treatment characteristics in modulating the outcome for the patients included in the present study. Results: The study group included 18 females and 33 males having a mean age (+/- standard deviation) of 61 years (+/- 11,48) and 59 years (+/- 12,04), respectively. After a median follow-up of 19 months, OS was 88,24% and DFS was 98,03%. Classic open surgery was performed in all patients, low anterior resection and Miles resection was performed in 36 and 15 patients, respectively. Adjuvant chemotherapy was administered to 5 patients. Nodal status was ypT0N0 in 50 patients, ypT0N1 in one patient. Two of the recorded factors, stenosis and circumferential resection margin (CRM), appeared to play a significant role in modifying OS. Conclusions: Most of the patients with LARC treated with neoadjuvant chemoradiation and radical surgery seem to have a favorable long-term outcome but the stenosis and the involvement of CRM appears to predict the postoperative OS. Further studies are needed to determine the role of other factors in predicting OS and DFS in patients with LARC and ypT0.

Transanal total mesorectal excision for patients with middle-low rectal cancer in locally advanced stage

Abstract Introduction: Patients with middle-low rectal cancer in advanced stage had many difficulties in performing laparoscopic total mesorectal excision (TME), especially in those with narrow pelvis or obese with or without neoadjuvant therapy. We conducted the study of transanal TME (TaTME) for these patients to evaluate the safety and efficacity of this technique. Material and Methods: Prospective study. Patients with middle-low rectal cancer in advanced stage underwent rectal resection with TaTME technique were enrolled. Results: 38 patients including 25 middle and 13 low rectal tumors underwent elective rectal resection by TaTME from March 2015 to September 2018. Male/female ratio: 25/13. Mean age: 58.2 ± 16.4 and BMI: 24.2 ±2.5 kg/m2. Mean operation duration:210 ± 42 minutes. Specimen were removed through abdominal incision in 23 patients and 15 via anus. Anastomoses were performed by hands in 100% patients. The protective ileostomie was performed 100%. One left ureteral burning and postoperative difficulty in voiding, one presacral abscess due to anastomotic fistula and one totally leakage of the anastomose. Good Quirke assessment in 87% patients. The distal resection margins (DRM) was 20 ± 5 mm. Distal resection margins (DRM) were negative in 100% patients and circumferential resection margins (CRM) were positive in one (2.6%) patients. The hospital stay was 6 days. Median follow-up time was 12 months. One patient had local recurrence at 18th months and 1 had liver metastasis at 6th months. Conclusion: TaTME for patients with middle-low rectal cancer in advanced stage is safe and efficacious. However, there is a need for large, multicentric studies to accurately evaluate this technique.

Evaluation of a Completion Total Mesorectal Excision in Patients After Local Excision of Rectal Cancer: A Word of Caution.

Background: According to Dutch guidelines, locally excised, low-risk, pT1 or ypT0-1 rectal cancer should not necessarily be followed by completion total mesorectal excision (cTME) in contrast to rectal cancers with higher T stages or unfavorable features. This study evaluated cTME after local excision at a national level with possible determinants for decision-making. Methods: All patients in the Dutch Colorectal Audit (DCRA) who underwent local excision of rectal cancer between 2012 and 2015 were included. Guideline adherence for performing cTME was determined with univariate and multivariate analyses to identify factors related to noncompliance. Results: According to the guidelines, of 530 included patients, cTME was indicated in 283 (53%), and among those, was performed in 82 (29%). Guideline adherence for performing cTME improved significantly (P<.001), from 10% in 2012 to 44% in 2015. Lower Charlson comorbidity index in patients with high-risk pT1 rectal cancer and younger patients (aged 61-70 years vs ≥80 years) with pT≥2 rectal cancer were associated with increased performance of cTME (odds ratio [OR], 13.50; 95% CI, 1.39-131.32, and OR, 6.25; 95% CI, 1.83-21.31, respectively). Conclusions: In this population-based study from the Netherlands, only a minority of patients underwent cTME after local excision of rectal cancer with pathologic features indicating the need for further treatment according to the guidelines. Although the percentage of patients undergoing cTME increased over time, the study indicated a tendency toward rectal-preserving treatment with potential oncologic risks.

Feasibility of Extended Dissection of Lateral Pelvic Lymph Nodes During Laparoscopic Total Mesorectal Excision in Patients with Locally Advanced Lower Rectal Cancer: A Single-Center Pilot Study After Neoadjuvant Chemotherapy.

BackgroundThe feasibility of additional dissection of the lateral pelvic lymph nodes (LPLNs) in patients undergoing total mesorectal excision (TME) combined with neoadjuvant chemotherapy (NAC) for locally advanced rectal cancer (LARC) is controversial. The use of laparoscopic surgery is also debated. In the present study, we evaluated the utility of laparoscopic dissection of LPLNs during TME for patients with LARC and metastatic LPLNs after NAC, based on our experience with 19 cases.Material/MethodsTwenty-five patients with LARC with swollen LPLNs who underwent laparoscopic TME and LPLN dissection were enrolled in this pilot study. The patients were divided into 2 groups: those patients with NAC (n=19) and without NAC (n=6). Our NAC regimen involved 4 to 6 courses of FOLFOX plus panitumumab, cetuximab, or bevacizumab.ResultsThe operative duration was significantly longer in the NAC group than in the non-NAC group (648 vs. 558 minutes, respectively; P=0.022). The rate of major complications, defined as grade ≥3 according to the Clavien-Dindo classification, was similar between the 2 groups (15.8% vs. 33.3%, respectively; P=0.4016). No conversion to conventional laparotomy occurred in either group. In the NAC group, a histopathological complete response was obtained in 2 patients (10.5%), and a nearly complete response (Tis N0 M0) was observed in one patient (5.3%). Although the operation time was prolonged in the NAC group, the other perioperative factors showed no differences between the 2 groups.ConclusionsLaparoscopic LPLN dissection is feasible in patients with LARC and clinically swollen LPLNs, even after NAC.

Feasibility of transanal total mesorectal excision in cases with challenging patient and tumor characteristics.

PurposeTo assess the feasibility of transanal total mesorectal excision in difficult cases including obese patients or patients with bulky tumors or threatened mesorectal fascias.MethodsWe performed laparoscopy-assisted transanal total mesorectal excision in patients with biopsy-proven rectal adenocarcinoma located 3–12 cm from the anal verge as part of a prospective, single arm, pilot trial. The primary endpoint was resection quality and circumferential resection margin involvement. Secondary endpoints included the number of harvested lymph nodes and 30-day postoperative complications.ResultsA total of 12 patients (9 men and 3 women) were enrolled: one obese patient, 7 with large tumors and 8 with threatened mesorectal fascias (4 patients had multiple indications). Tumors were located a median of 5.5 cm from the anal verge, and all patients received preoperative chemoradiotherapy. Median operating time was 191 minutes, and there were no intraoperative complications. One patient needed conversion to open surgery for ureterocystostomy after en bloc resection. Complete or near-complete excision and negative circumferential resection margins were achieved in all cases. The median number of harvested lymph nodes was 15.5. There was no postoperative mortality and 3 cases of postoperative morbidity (1 postoperative ileus, 1 wound problem near the stoma site, and 1 anastomotic dehiscence).ConclusionThis pilot study showed that transanal total mesorectal excision is also feasible in difficult laparoscopic cases such as in obese patients or those with bulky tumors or tumors threatening the mesorectal fascia. Additional larger studies are needed.