Background The standard treatment of rectal carcinoma is surgical resection according to the total mesorectal excision principle, either by open, laparoscopic, robot-assisted or transanal technique. No clear consensus exists regarding the length of the learning curve for the minimal invasive techniques. This systematic review aims to provide an overview of the current literature regarding the learning curve of minimal invasive TME. Methods A systematic literature search was performed. PubMed, Embase and Cochrane Library were searched for studies with the primary or secondary aim to assess the learning curve of either laparoscopic, robot-assisted or transanal TME for rectal cancer. The primary outcome was length of the learning curve per minimal invasive technique. Descriptive statistics were used to present results and the MINORS tool was used to assess risk of bias. Results 45 studies, with 7562 patients, were included in this systematic review. Length of the learning curve based on intraoperative complications, postoperative complications, pathological outcomes, or a composite endpoint using a risk-adjusted CUSUM analysis was 50 procedures for the laparoscopic technique, 32–75 procedures for the robot-assisted technique and 36–54 procedures for the transanal technique. Due to the low quality of studies and a high level of heterogeneity a meta-analysis could not be performed. Heterogeneity was caused by patient-related factors, surgeon-related factors and differences in statistical methods. Conclusion Current high-quality literature regarding length of the learning curve of minimal invasive TME techniques is scarce. Available literature suggests equal lengths of the learning curves of laparoscopic, robot-assisted and transanal TME. Well-designed studies, using adequate statistical methods are required to properly assess the learning curve, while taking into account patient-related and surgeon-related factors.
Purpose Evidence regarding the learning curve of robot-assisted total mesorectal excision is scarce and of low quality. Case-mix is mostly not taken into account, and learning curves are based on operative time, while preferably clinical outcomes and literature-based limits should be used. Therefore, this study aims to assess the learning curve of robot-assisted total mesorectal excision. Methods A retrospective study was performed in four Dutch centers. The primary aim was to assess the safety of the individual and institutional learning curves using a RA-CUSUM analysis based on intraoperative complications, major postoperative complications, and compound pathological outcome (positive circumferential margin or incomplete TME specimen). The learning curve for efficiency was assessed using a LC-CUSUM analysis for operative time. Outcomes of patients before and after the learning curve were compared. Results In this study, seven participating surgeons performed robot-assisted total mesorectal excisions in 531 patients. Learning curves for intraoperative complications, postoperative complications, and compound pathological outcome did not exceed predefined literature-based limits. The LC-CUSUM for operative time showed lengths of the learning curve ranging from 12 to 35 cases. Intraoperative, postoperative, and pathological outcomes did not differ between patients operated during and after the learning curve. Conclusion The learning curve of robot-assisted total mesorectal excision based on intraoperative complications, postoperative complications, and compound pathological outcome did not exceed predefined limits and is therefore suggested to be safe. Using operative time as a surrogate for efficiency, the learning curve is estimated to be between 12 and 35 procedures.
Background The sole presence of deep submucosal invasion is shown to be associated with a limited risk of lymph node metastasis. This justifies a local excision of suspected deep submucosal invasive colon carcinomas (T1 CCs) as a first step treatment strategy. Recently Colonoscopy-Assisted Laparoscopic Wedge Resection (CAL-WR) has been shown to be able to resect pT1 CRCs with a high R0 resection rate, but the long term outcomes are lacking. The aim of this study is to evaluate the safety, effectiveness and long-term oncological outcomes of CAL-WR as primary treatment for patients with suspected superficial and also deeply-invasive T1 CCs. Methods In this prospective multicenter clinical trial, patients with a macroscopic and/or histologically suspected T1 CCs will receive CAL-WR as primary treatment in order to prevent unnecessary major surgery for low-risk T1 CCs. To make a CAL-WR technically feasible, the tumor may not include > 50% of the circumference and has to be localized at least 25 cm proximal from the anus. Also, there should be sufficient distance to the ileocecal valve to place a linear stapler. Before inclusion, all eligible patients will be assessed by an expert panel to confirm suspicion of T1 CC, estimate invasion depth and subsequent advise which local resection techniques are possible for removal of the lesion. The primary outcome of this study is the proportion of patients with pT1 CC that is curatively treated with CAL-WR only and in whom thus organ-preservation could be achieved. Secondary outcomes are 1) CAL-WR’s technical success and R0 resection rate for T1 CC, 2) procedure-related morbidity and mortality, 3) 5-year overall and disease free survival, 4) 3-year metastasis free survival, 5) procedure-related costs and 6) impact on quality of life. A sample size of 143 patients was calculated. Discussion CAL-WR is a full-thickness local resection technique that could also be effective in removing pT1 colon cancer. With the lack of current endoscopic local resection techniques for > 15 mm pT1 CCs with deep submucosal invasion, CAL-WR could fill the gap between endoscopy and major oncologic surgery. The present study is the first to provide insight in the long-term oncological outcomes of CAL-WR. Trial registration CCMO register (ToetsingOnline), NL81497.075.22, protocol version 2.3 (October 2022).
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