Italian Study on the Right Hemicolectomy: How the Lymphadenectomy is Performed (CoDIG-2)

Gabriele Anania

Status: Completed

Conditions: Lymph Node Metastasis; Surgical Procedure, Unspecified; Colon Cancer

Treatments: Procedure: Right hemicolectomy

Study type: Observational

Funder types: Other

Identifiers

NCT05943951

CoDIG-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 788 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients and/or legal guardians, where applicable, have been fully informed and have voluntarily provided informed written consent or patients unable to read and/or write who have fully understood the information verbally provided by the investigator and who have provided a verbal consent testified in writing by a third person.

  • Patients aged > 18, men and women, operated by laparoscopic right hemiolectomy or video assisted, under election regime at the U.O. General and Thoracic Surgery with diagnosis of colic adenocarcinoma at any stage.
  • Patients who have already undergone chemotherapy and radiotherapy for other reasons.

Exclusion criteria

• Under age.
• Patients undergoing emergency surgery.
• Women who are pregnant.
• Patients with right-handed laparotomy