NCT05943951

Italian Study on the Right Hemicolectomy: How the Lymphadenectomy is Performed

Lymphadenectomy in Right Hemicolectomy: Italian Multicenter Study (CoDIG-2)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 788 (actual)
• Sponsor: Gabriele Anania · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is the analysis of lymphadenectomy in the course of right hemicolectomy, in relation to the radicality of the surgical resection that is performed. In particular, the investigators wants to inquire how according to precise standards regarding surgical radicalness and consequently the anatomical piece that is obtained it is possible to correlate a certain number of lymph nodes and their possible positivity. The lead center is the General and Thoracic Surgery Department of the University of Ferrara. Prof. Anania is the responsible for the enrollment of patients and the coordination with the collaborating centers in the six month-study

Detailed description

All the high-volume specialist centres that perform this type of intervention in Italy will be invited, with a minimum number of 25 interventions per year. At the end of the study 788 patients was enrolled. The data of the patients involved will be collected independently and anonymously by the individual centers involved, using a common alpha numeric code decided by the coordinating center. The parameters examined will be: * Personal data of the patient * Stage of neoplasm due to surgery * Type of surgery and duration * Post-operative course * Presence of post-surgical complications and eventual hospital readmission due to these complications * Study of the operating piece and lymphadenectomy performed: Tumor free margin Terminal ilium length The different vascular ligatures and levels at which they are performed Integrity of the mesocolon Number of positive nodes per total removed Following the end of the 6 months of observational study period, the data will be processed anonymously at the coordinating centre.

Conditions

• Colon Cancer
• Lymph Node Metastasis
• Surgical Procedure, Unspecified

Interventions

Type	Name	Description
PROCEDURE	Right hemicolectomy	It begins with a thorough laparoscopic inspection of the abdomen for evidence of metastatic disease and to confirm the location of the tumor. Usually is performed dissection using a medial-to-lateral approach. A lateral or inferior approach can also be used depending on the anatomy. The vascular dissection may begin at the ileocolic pedicle or over the superiore mesenteric vein. After completing the medial-to-lateral dissection, the sourgeons return to the ileocolic pedicle to begin vascular dissection. Whether a D2 (until encountering the right branch of the middle colic) or D3 dissection (until the root of ileocolic artery and vein) is performed depends upon the tumor stage. For an intracorporeal anastomosis, the bowel is transected proximally and distally using a linear stapler. The terminal ileum is positioned along the transverse colon in an isoperistaltic fashion. After that a colotomy and an enterotomy are made on the antimesenteric edge of the colon and small bowel respectively

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-09-30
• Completion: 2022-10-30
• First posted: 2023-07-13
• Last updated: 2023-07-13

Locations

62 sites across 1 country: Italy