Complete mesocolic excision in comparison with conventional surgery for right colon cancer: a nationwide multicenter study of the Italian Society of Surgical Oncology colorectal cancer network (CoME-in trial). Study protocol for a randomized controlled trial

Degiuli, Maurizio; Solej, Mario; Aguilar, Hogla Aridai Resendiz; Marchiori, Giulia; Reddavid, Rossella

doi:10.1093/jjco/hyac116

Cited by 6 publications

(6 citation statements)

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“…The types of surgical interventions are detailed in the previously published study protocol. 19 The anastomoses were performed manually or mechanically based on each surgeon’s preference. A strict quality control was applied to surgery, pathology, and follow-up evaluation.…”

Section: Methodsmentioning

confidence: 99%

“…Based on the results of this interim assessment, the study was stopped if no significant interim increase in LN yield was documented in the experimental arm. 19 The p values for multiple comparisons have been adjusted via Bonferroni 23 correction.…”

Section: Methodsmentioning

confidence: 99%

“…Our multicenter trial with a large Western population aims to investigate the three main outcomes of a controlled CME: the quality of surgery (number of nodes retrieved, integrity and area of resected mesocolon, length of IC and MC vessels, and Benz classification), its safety (intra- and postoperative complications), and its efficacy (early oncologic items and survival rates). 19 In this report, we describe the interim analysis of the study concerning early results (safety and quality of surgery, mostly the number of LNs retrieved). Documentation of a significant increase in the number of LNs removed in the CME arm after enrollment of about 50% of the expected patients also is strongly required by the design of the trial as the essential issue necessary for continuation of patient recruitment.…”

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confidence: 99%

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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)

Degiuli,

Aguilar,

Solej

et al. 2023

Ann Surg Oncol

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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.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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confidence: 99%

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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)

Degiuli,

Aguilar,

Solej

et al. 2023

Ann Surg Oncol

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“…However, results of a recent meta-analysis and interim analysis of a randomized multicentre trial separately suggest a higher lymph node yield with no increase in perioperative complications [19,54] and improved 5-year DFS and OS [19] following CME surgery, favouring its routine application in management of nonmetastatic rightsided colonic malignancies. In addition, it is also proven to be safer when performed using the robot [55], and in the unfortunate event of a vascular injury the repair can be done robotically provided the expertise is available.…”

Section: Vascular Dissectionmentioning

confidence: 99%

Robotic approach to colonic resection: For some or for all patients?

Subramaniam,

Piozzi,

Kim

et al. 2024

Colorectal Disease

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The robotic approach is rapidly gaining momentum in colorectal surgery. Its benefits in pelvic surgery have been extensively discussed and are well established amongst those who perform minimally invasive surgery. However, the same cannot be said for the robotic approach for colonic resection, where its role is still debated. Here we aim to provide an extensive debate between selective and absolute use of the robotic approach for colonic resection by combining the thoughts of experts in the field of robotic and minimally invasive colorectal surgery, dissecting all key aspects for a critical view on this exciting new paradigm in colorectal surgery.

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“…They emphasized that surgical dissection must strictly follow the embryological planes to remove the diseased colon and its mesentery as a unit and prevent the leakage of cancer cells. To date, there have been several studies, with others in progress [ 7 ], comparing these two techniques. Recently, we have seen that the CME procedure harvests a larger area of the mesentery and more lymph nodes, but the duration of surgery is longer with CME than with D2 [ 2 , 8 , 9 ].…”

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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)

Anania,

Chiozza,

Campagnaro

et al. 2024

Surg Endosc

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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.

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Complete mesocolic excision in comparison with conventional surgery for right colon cancer: a nationwide multicenter study of the Italian Society of Surgical Oncology colorectal cancer network (CoME-in trial). Study protocol for a randomized controlled trial

Cited by 6 publications

References 10 publications

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)

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)

Robotic approach to colonic resection: For some or for all patients?

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)

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