Surgical quality assessment for the prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for nonmetastatic right colon cancer (PIONEER study).

BACKGROUND: The modified complete mesocolic excision (mCME) procedure for right-sided colon cancer is a tailored approach based on the original complete mesocolic excision (CME) methodology. Limited studies evaluated the safety and feasibility of laparoscopic mCME using objective surgical quality assessments in patients with right colon cancer. The objectives of the PIONEER study were to evaluate oncologic outcomes after laparoscopic mCME and to identify optimal clinically relevant endpoints and values for standardizing laparoscopic right colon cancer surgery based on short-term outcomes of procedures performed by expert laparoscopic surgeons. MATERIALS AND METHODS: This is an ongoing prospective, multi-institutional, single-arm study conducted at five tertiary colorectal cancer centers in South Korea. Study registrants included 250 patients scheduled for laparoscopic mCME with right-sided colon adenocarcinoma (from the appendix to the proximal half of the transverse colon). The primary endpoint was 3-year disease-free survival. Secondary outcomes included 3-year overall survival, incidence of morbidity in the first 4 weeks postoperatively, completeness of mCME, central radicality, and distribution of metastatic lymph nodes. Survival data will be available after the final follow-up date (June 2024). RESULTS: The postoperative complication rate was 12.9%, with a major complication rate of 2.7%. In 87% of patients, central radicality was achieved with dissection at or beyond the level of complete exposure of the superior mesenteric vein. Mesocolic plane resection with an intact mesocolon was achieved in 75.9% of patients, as assessed through photographs. Metastatic lymph node distribution varied by tumor location and extent. Seven optimal clinically relevant endpoints and values were identified based on the analysis of complications in low-risk patients. CONCLUSIONS: Laparoscopic mCME for right-sided colon cancer produced favorable short-term postoperative outcomes. The identified optimal clinically relevant endpoints and values can serve as a reference for evaluating surgical performance of this procedure.

Developing a phantom for simulating robotic-assisted complete mesocolic excision using 3D printing and medical imaging.

BACKGROUND: Robotic-assisted complete mesocolic excision is an advanced procedure mainly because of the great variability in anatomy. Phantoms can be used for simulation-based training and assessment of competency when learning new surgical procedures. However, no phantoms for robotic complete mesocolic excision have previously been described. This study aimed to develop an anatomically true-to-life phantom, which can be used for training with a robotic system situated in the clinical setting and can be used for the assessment of surgical competency. METHODS: Established pathology and surgical assessment tools for complete mesocolic excision and specimens were used for the phantom development. Each assessment item was translated into an engineering development task and evaluated for relevance. Anatomical realism was obtained by extracting relevant organs from preoperative patient scans and 3D printing casting moulds for each organ. Each element of the phantom was evaluated by two experienced complete mesocolic excision surgeons without influencing each other's answers and their feedback was used in an iterative process of prototype development and testing. RESULTS: It was possible to integrate 35 out of 48 procedure-specific items from the surgical assessment tool and all elements from the pathological evaluation tool. By adding fluorophores to the mesocolic tissue, we developed an easy way to assess the integrity of the mesocolon using ultraviolet light. The phantom was built using silicone, is easy to store, and can be used in robotic systems designated for patient procedures as it does not contain animal-derived parts. CONCLUSIONS: The newly developed phantom could be used for training and competency assessment for robotic-assisted complete mesocolic excision surgery in a simulated setting.

Laparoscopic right hemicolectomy: a SICE (Società Italiana di Chirurgia Endoscopica e Nuove tecnologie) network prospective study on the approach to right colon lymphadenectomy in Italy: is there a standard?-CoDIG 2 (ColonDx Italian Group).

BACKGROUND: Colon cancer is a disease with a worldwide spread. Surgery is the best option for the treatment of advanced colon cancer, but some aspects are still debated, such as the extent of lymphadenectomy. In Japanese guidelines, the gold standard was D3 dissection to remove the central lymph nodes (203, 213, and 223), but in 2009, Hoenberger et al. introduced the concept of complete mesocolic excision, in which surgical dissection follows the embryological planes to remove the mesentery entirely to prevent leakage of cancer cells and collect more lymph nodes. Our study describes how lymphadenectomy is currently performed in major Italian centers with an unclear indication on the type of lymphadenectomy that should be performed during right hemicolectomy (RH). METHODS: CoDIG 2 is an observational multicenter national study that involves 76 Italian general surgery wards highly specialized in colorectal surgery. Each center was asked not to modify their usual surgical and clinical practices. The aim of the study was to assess the preference of Italian surgeons on the type of lymphadenectomy to perform during RH and the rise of any new trends or modifications in habits compared to the findings of the CoDIG 1 study conducted 4 years ago. RESULTS: A total of 788 patients were enrolled. The most commonly used surgical technique was laparoscopic (82.1%) with intracorporeal (73.4%), side-to-side (98.7%), or isoperistaltic (96.0%) anastomosis. The lymph nodes at the origin of the vessels were harvested in an inferior number of cases (203, 213, and 223: 42.4%, 31.1%, and 20.3%, respectively). A comparison between CoDIG 1 and CoDIG 2 showed a stable trend in surgical techniques and complications, with an increase in the robotic approach (7.7% vs. 12.3%). CONCLUSIONS: This analysis shows how lymphadenectomy is performed in Italy to achieve oncological outcomes in RH, although the technique to achieve a higher lymph node count has not yet been standardized. Trial registration (ClinicalTrials.gov) ID: NCT05943951.

Radiological characteristics and diagnostic clues for persistent descending mesocolon in patients with rectal cancer.

PURPOSE: Persistent descending mesocolon (PDM) increases the difficulty and colonic ischemia in the surgery of colorectal cancer, but the preoperative diagnostic criteria have not yet been clearly demonstrated. This study explored the MR imaging features and diagnostic criteria of PDM to improve the preoperative diagnostic rate. METHODS: The clinical data of 54 patients with PDM and 270 patients without PDM who underwent rectal surgery at the Department of Colorectal Surgery, Fujian Medical University Union Hospital, from March 2018 to December 2022 were analyzed, retrospectively. The radiological parameters of PDM from MRI were analyzed. RESULTS: On MRI T2WI axial image, the left edge of the abdominal aorta was defined as the reference line. The shortest vertical distance between the right edge of the descending colon and this line (dN) and the maximum transverse diameter of the peritoneal cavity (dA) at the same level and the maximum vertical distance between the right edge of the descending colon and this line (dW) were measured. There were significant statistical differences in dN, dW, dN/dW, and dN/dA between the PDM group and the non-PDM group. dN, dN/dW, and dN/dA have high diagnostic performance for the PDM. dN < 4.16 cm, dN/dW < 0.52, and dN/dA < 0.15 can all be used as clues to diagnose PDM. CONCLUSIONS: We propose a feasible set of diagnostic criteria for PDM based on abdominal MRI, which can quickly and accurately diagnose PDM, and provide some reference for preoperative planning and surgical decision-making.

Complete mesocolic excision for right colon cancer: Is D3 lymphadenectomy necessary?

AIM: Although complete mesocolic excision (CME) for colon cancer is oncologically sound, to date, there has been no consensus on the extent of lymphadenectomy in radical right colectomy. This study essentially compared the perioperative and survival outcomes of CME with two templates of lymphadenectomy for right colon cancer. METHOD: This was a propensity matched, retrospective analysis of a single centre, prospectively maintained database of all patients undergoing elective right colectomy for nonmetastatic, biopsy-proven adenocarcinoma from November 2013 to October 2018. CME + D3 was adopted selectively, documented prospectively, and compared with patients undergoing CME + central vascular ligation (CVL). The only technical difference between the groups was the excision of the surgical trunk of Gillot in the CME + D3 group. Postoperative, long-term outcomes and patterns of recurrence were compared between the groups. RESULTS: Of the 244 eligible patients, 88 (36.1%) and 156 (63.9%) underwent CME + D3 and CME + CVL, respectively. Matched groups (72 [CME + D3] vs. 108 [CME + CVL]) showed no difference in histology, tumour grade, postoperative complications, mortality, and hospital stay. CME + D3 was preferentially performed laparoscopically (35.2% vs. 9%), was associated with lower blood loss (215 mL vs. 297 mL, p = 0.001), higher nodal yield (31 vs. 25 nodes, p = 0.003) and a higher incidence of chyle leak (4 vs. 0, p = 0.013). At a median follow-up of more than 57 months, there was no significant difference in local recurrence, disease-free or overall survival. CONCLUSION: In this retrospective study, lymphadenectomy along the superior mesenteric vein, as a component of CME for right colon cancer, offered a higher nodal yield with no improvement in oncological outcome. Dissection of the SMV, over and above a D2 dissection, could therefore be restricted to specialized colorectal units until further studies establish the incremental oncological benefit of this extended lymphadenectomy or define a patient group in whom it is beneficial.

A Randomized Phase III Trial of Complete Mesocolic Excision Compared with Conventional Surgery for Right Colon Cancer: Interim Analysis of a Nationwide Multicenter Study of the Italian Society of Surgical Oncology Colorectal Cancer Network (CoME-in trial).

BACKGROUND: Although complete mesocolic excision (CME) is supposed to be associated with a higher lymph node (LN) yield, decreased local recurrence, and survival improvement, its implementation currently is debated because the evidence level of these data is rather low and still not supported by randomized controlled trials. METHOD: This is a multicenter, randomized, superiority trial (NCT04871399). The 3-year disease-free survival (DFS) was the primary end point of the study. The secondary end points were safety (duration of operation, perioperative complications, hospital length of stay), oncologic outcomes (number of LNs retrieved, 3- and 5-year overall survival, 5-year DFS), and surgery quality (specimen length, area and integrity rate of mesentery, length of ileocolic and middle-colic vessels). The trial design required the LN yield to be higher in the CME group at interim analysis. RESULTS: Interim data analysis is presented in this report. The study enrolled 258 patients in nine referral centers. The number of LNs retrieved was significantly higher after CME (25 vs. 20; p = 0.012). No differences were observed with respect to intra- or post-operative complications, postoperative mortality, or duration of surgery. The hospital stay was even shorter after CME (p = 0.039). Quality of surgery indicators were higher in the CME arm of the study. Survival data still were not available. CONCLUSIONS: Interim data show that CME for right colon cancer in referral centers is safe and feasible and does not increase perioperative complications. The study documented with evidence that quality of surgery and LN yield are higher after CME, and this is essential for continuation of patient recruitment and implementation of an optimal comparison. Trial registration The trial was registered at ClinicalTrials.gov with the code NCT04871399 and with the acronym CoME-In trial.

Complete mesocolic excision for colon cancer: current status and controversies.

According to Hohenberger's original description, complete mesocolic excision for colon cancer involves precise dissection of the avascular embryonic plane between the parietal retroperitoneum and visceral peritoneum of the mesocolon. This ensures mesocolic integrity, access to high ligation of the supplying vessels at their origin and an associated extended lymphadenectomy. Results from centres which have adopted this approach routinely have demonstrated that oncological outcomes can be improved by the rigorous implementation of established principles of cancer surgery. Meticulous anatomical dissection along embryonic planes is a well-established principle of precision cancer surgery used routinely by the specialist colorectal surgeon. Therefore, the real question concerns the need for true central vascular ligation and associated extended (D3) lymphadenectomy or otherwise, particularly along the superior mesenteric vessels when performing a right colectomy. Whether this approach results in improved overall or disease-free survival remains unclear and its role remains controversial particularly given the potential for significant morbidity associated with a more extensive central vascular dissection. Current literature is limited by considerable bias, as well as inconsistent and variable terminology, and the results of established randomized trials are awaited. As a result of the current state of equipoise, various national guidelines have disparate recommendations as to when complete mesocolic excision should be performed if at all. This article aims to review the rationale for and technical aspects of complete mesocolic excision, summarize available short and long term outcome data and address current controversies.

Technical assessment in minimally invasive complete mesocolic excision: Is the complete mesocolic excision competency assessment tool valid and reliable?

AIM: The complete mesocolic excision competency assessment tool (CMECAT) is a novel tool designed to assess technical skills in minimally invasive complete mesocolic excision (CME) surgery. The aim of this study was to assess construct validity and reliability of CMECAT in a clinical context. METHOD: Colorectal surgeons were asked to submit video recorded laparoscopic CME resections for independent assessment of their technical abilities. The videos were grouped by surgeons' training level, and four established CME experts were recruited as CMECAT assessors. Extended reliability analysis (G-theory) was applied to describe assessor agreement. RESULTS: A total of 19 videos and 72 assessments were included in the analysis. Overall, technical skills assessed by CMECAT improved with increased training level: the experts scored significantly better than the untrained surgeons (3.3 vs. 2.5 points; p < 0.01). On right-sided resections, significantly higher scores were reported with increased training level for all categories and sections, while for left-sided resections, the variance across groups was smaller and significantly higher scores were only reported for oncological safety describing items. Overall, assessor agreement was high (G-coefficient: 0.81). CONCLUSION: This study confirms that CMECAT can be applied to video recorded CME cases for technical skill assessment. Further, it can reliably assess technical performance in right sided CME surgery, where construct validity has now been established. More videos are required to evaluate its validity on left colonic CME. In the future, we hope CMECAT can improve feedback during CME training, serve as a tool in certification processes and contribute to distinguishing CME from conventional surgery in future research.