Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-25 @ 12:57 AM
Study NCT ID:
NCT05943951
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Italian Study on the Right Hemicolectomy: How the Lymphadenectomy is Performed
Sponsor:
Gabriele Anania
Organization:
Study Overview
Official Title:
Lymphadenectomy in Right Hemicolectomy: Italian Multicenter Study (CoDIG-2)
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoDIG-2
Brief 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
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: