The Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision
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ABSTRACT:
DISEASE(S): Rectal Neoplasms,Colorectal Neoplasms,Rectal Cancer
PROVIDER: 2151261 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed.
Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.
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Project description:A prospective study is planned for management of low rectal cancer with the aim of sphincter preservation and improving the oncological outcome of the patients, through comparing of both approaches minimally invasive techniques including transanal total mesorectal excision and laparoscopic intersphincteric resection.
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Project description:Transanal total mesorectal excision (TaTME) is a novel approach pioneered to tackle the challenges posed by difficult pelvic dissections in rectal cancer and the restrictions in angulation of currently available laparoscopic staplers. To date, four techniques can be employed in order to create the colorectal/coloanal anastomosis following TaTME. We present a technical note describing these techniques and discuss the risks and benefits of each.
| S-EPMC4757625 | biostudies-literature
Project description:Transanal total mesorectal excision (taTME) has evolved over the past decade fueled by advances in minimally invasive surgery. The technique aims to overcome the constraints posed by a narrow rigid pelvis and poor TME visualization that are encountered during "top-down" rectal surgery. A more accurate pelvic dissection should subsequently result in safer oncological resections and better preservation of pelvic autonomic nerves. taTME is an advanced complex technique that requires dedicated training and experience in TME surgery. Initial results from small cohorts are promising and confirmation by randomized controlled trials is eagerly awaited.
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Project description:The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for Total Mesorectal Excision Surgery.
| 2188410 | ecrin-mdr-crc
Project description:Total mesorectal excision (TME) is a rather new operation technique in the treatment of rectal cancer. It is known to reduce the rate of local recurrences. However, the influence on long-term survival is unclear.
| 2072941 | ecrin-mdr-crc
Project description:Background:Transanal total mesorectal excision (taTME) has recently emerged as a promising novel surgical procedure for rectal cancer. It is believed to hold the potential advantage of providing better access to mobilize the distal rectum and achieving better pathologic results. This study aimed to evaluate the feasibility of taTME for rectal cancer and summarize the preliminary experience in 10 Chinese hospitals. Methods:A total of 211 patients were enrolled in this study. Variables for evaluation of safety, feasibility, and oncologic outcomes were retrospectively collected and analysed. Results:The median distance between the tumor and the anal verge was 5.9?cm (range, 1.5-12?cm). The median operating time was 280?min (range, 70-600?min) and the median estimated intra-operative blood loss was 50?mL (range, 10-1,500?mL). The overall rate of complication was 27.9%. Among the 211 patients, 175 (82.9%) had complete TME and 33 (15.6%) had near complete TME. The circumferential resection margin was negative in 97.7% of patients. The patients were followed for a median of 35?months (range, 2-86?months). There was 7.6% (16) mortality, 6.2% (13) had local recurrence, and 12.8% (27) had systemic recurrence. Kaplan-Meier survival analysis showed that 1-, 2-, and 3-year disease-free survival rates were 94.8%, 89.3%, and 80.2%, respectively, and 1-, 2-, and 3-year OS rates were 97.4%, 95.7%, and 92.9%, respectively. Conclusions:Although limited by its retrospective nature, taTME was safe and feasible in selected patients. Future work with rigorous data recording is warranted.
| S-EPMC7034231 | biostudies-literature
Project description:The management of rectal cancer has evolved over the years, including the recent rise of Transanal Total Mesorectal Excision (TaTME). TaTME addresses the limitations created by the bony confines of the pelvis, bulky tumours, and fatty mesorectum, particularly for low rectal cancers. However, guidance is required to ensure safe implementation and to avoid the pitfalls and potential major morbidity encountered by the early adopters of TaTME. We report a broad international consensus statement, which provides a basis for optimal clinical practice.Forty international experts were invited to participate based on clinical and academic achievements. The consensus statements were developed using Delphi methodology incorporating three successive rounds. Consensus was defined as agreement by 80% or more of the experts.A total of 37 colorectal surgeons from 20 countries and 5 continents (Europe, Asia, North and South America, Australasia) contributed to the consensus. Participation to the iterative Delphi rounds was 100%. An expert radiologist, pathologist, and medical oncologist provided recommendations to maximize relevance to current practice. Consensus was obtained on all seven different chapters: patient selection and surgical indication, perioperative management, patient positioning and operating room set up, surgical technique, devices and instruments, pelvic anatomy, TaTME training, and outcomes analysis.This multidisciplinary consensus statement achieved more than 80% approval and can thus be graded as strong recommendation, yet acknowledging the current lack of high level evidence. It provides the best possible guidance for safe implementation and practice of Transanal Total Mesorectal Excision.
| S-EPMC5807525 | biostudies-other
Project description:ImportanceProponents of novel transanal total mesorectal excision (TME) suggest the procedure overcomes the technical and oncologic challenges of conventional approaches for treating rectal cancer. Recently, however, there has been controversy regarding the oncologic safety of the procedure.ObjectiveTo assess the association of transanal TME with the incidence of local recurrence (LR) of cancer and the probability of remaining free of LR during follow-up.Design, setting, and participantsThis multicenter cohort study used data from 8 high-volume rectal cancer academic institutions from across Canada on all consecutive patients with primary rectal cancer treated by transanal TME at the participating centers. The study was conducted between January 2014 and December 2018, and data were analyzed from April 1, 2020, to September 15, 2020.ExposureTransanal TME.Main outcomes and measuresThe incidence of LR was reported as a direct measure of quality of resection. The cumulative probability of LR- and systemic recurrence (SR)-free survival at 36 months was estimated. Local recurrence and SR were defined as radiologic or endoscopic evidence of 1 or more new lesions in or outside the pelvis, respectively, documented during surveillance after the removal of the primary tumor.ResultsOf 608 total patients included in the analysis, 423 (69.6%) were male; the median age was 63 years (interquartile range [IQR], 54-70 years). Local recurrence was identified in 22 patients (3.6%) after a median follow-up of 27 months (IQR, 18-38 months). The median time to LR was 13 months (IQR, 9-19 months). Sixteen of the 22 patients with LR (72.7%) were male, 14 (63.6%) received neoadjuvant chemoradiation, and 12 (54.5%) had American Joint Committee on Cancer stage III disease. Of those with LR, 16 (72.7%) had a negative circumferential radial margin and 20 (90.9%) had a negative distal resection margin, 2 (9.1%) experienced conversion to open surgery, and 15 (68.2%) also developed SR. The probability of LR-free survival at 36 months was 96% (95% CI, 94%-98%). According to the Cox proportional hazards regression model, the hazard ratio of LR was estimated to be 4.2 (95% CI, 2.9-6.2) times higher among patients with a positive circumferential radial margin than among those with a negative circumferential radial margin.Conclusions and relevanceIn this cohort study, transanal TME performed by experienced surgeons was associated with an incidence of LR and SR that is in line with the published literature on open and laparoscopic TME, suggesting that transanal TME may be an acceptable approach for management of rectal cancer.
| S-EPMC7859847 | biostudies-literature
Project description:BackgroundTransanal 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.MethodsOncological 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.ResultsThe 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).ConclusionTaTME 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.
| S-EPMC7496604 | biostudies-literature