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

Sponsor

Gabriele Anania (Other)

Overall Status

Completed

CT.gov ID

NCT05943951

Collaborator

(none)

788

Enrollment

Locations

Actual Duration (Months)

12.7

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Lymph Node Metastasis Surgical Procedure, Unspecified	Procedure: Right hemicolectomy

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.

Study Design

Study Type:

Observational

Actual Enrollment :

788 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

Sep 30, 2022

Actual Study Completion Date :

Oct 30, 2022

Outcome Measures

Primary Outcome Measures

the analysis of lymphadenectomy in the course of right hemciolectomy, in relation to the radicality of surgical resection that is performed [6 months]
In particular, the invastigators want 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. In the study various items about lymphadenectomy will be invastigated: tumor free margin > 5cm, lenght of teminal ileum > 10cm, different level at which colic vessel are closed (proximal or distal ligation) and consequentially the different lymph nodes stations collected, mesocolic sail integrity based on Benz score, number of lymph node harvest and number of lymph nodes positive for metastatic involvement, type of surgical procedure (video-assisted, laparoscopic, robotic).

Secondary Outcome Measures

Vascular anatomical variability [6 months]
The investigators wants to study the vascular anatomical variability of the patients enrolled in the study, and how this variability may affect the extent of lymphoadenectomy. The investigators will analize the vessels anatomy with pre-operative imaging (CT scan) and with intra-operative feedback. The attention will be on the position of superior mesenteric artery relative to superior mesenteric vein (before or behind). Futhermore the invastigators wants to study the anatomical variants of the vessels: the presence of the middle colic artery and its branches, the presence of the right colic artery and their variability in percentage terms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Carlo Urbani	Jesi	Ancona	Italy
2	Ospedale Generale Regionale F. Miulli	Acquaviva Delle Fonti	Bari	Italy
3	IRCCS Saverio de Bellis	Castellana Grotte	Bari	Italy
4	Policlinico San Marco Zingonia	Osio Sotto	Bergamo	Italy
5	Ospedale Valcamonica	Esine	Brescia	Italy
6	ASST Spedali Civili	Montichiari	Brescia	Italy
7	Ospedale Santa Maria Annunziata	Bagno A Ripoli	Firenze	Italy
8	Ospedale Nuovo di Legnano	Legnano	Milano	Italy
9	Ospedale San Giovanni di Dio Frattamaggiore	Frattamaggiore	Napoli	Italy
10	Ospedale Immacolata Concezione Piove di Sacco ULSS 6	Piove Di Sacco	Padova	Italy
11	Ospedale San Paolo	Civitavecchia	Roma	Italy
12	Ospedale CTO	Iglesias	Sud Sardegna	Italy
13	Ospedale San Valentino	Montebelluna	Treviso	Italy	31044
14	Ospedale di Latisana	Latisana	Udine	Italy
15	Ospedale San Pietro e Paolo	Borgosesia	Vercelli	Italy
16	Ospedale Umberto I	Ancona		Italy
17	Ospedale Bonomo	Andria		Italy
18	Ospedale Regionale U. Parini	Aosta		Italy
19	Policlinico Ponte San Pietro	Bergamo		Italy
20	ASL Biella	Biella		Italy
21	IRCCS AOU Bologna, Sant'Orsola	Bologna		Italy
22	Ospedale centrale di Bolzano	Bolzano		Italy
23	Azienda Ospedaliero universitaria di Cagliari	Cagliari		Italy
24	PO Santissima Trinità ASL Cagliari	Cagliari		Italy
25	AOU Mater Domini Università Magna Grecia Catanzaro	Catanzaro		Italy
26	Anania Gabriele	Ferrara		Italy	44124
27	AOU Careggi	Firenze		Italy
28	Ospedale San Giovanni di Dio	Firenze		Italy
29	Azienda Ospedaliero Universitaria di Foggia	Foggia		Italy
30	Ospedale Morgagni-Pierantoni	Forlì		Italy
31	P.O. San Salvatore	L'Aquila		Italy
32	Ospedale civile di Macerata	Macerata		Italy
33	AO Papardo	Messina		Italy
34	IRCCS Ca Granada Ospedale Maggiore Policlinico Milano	Milano		Italy
35	Ospedale San Raffaele	Milano		Italy
36	AOU Modena	Modena		Italy
37	AORN dei Colli - Ospedale Monaldi	Napoli		Italy
38	AOU Federico II di Napoli	Napoli		Italy
39	Isitituto Nazionale Tumori ICRSS Fondazione G. Pascale	Napoli		Italy
40	Policlinico P. Giaccone	Palermo		Italy
41	Ospedali Riuniti Marche Nord	Pesaro		Italy	61121
42	Ospedale Civile Santo Spirito	Pescara		Italy
43	Azienda Ospedaliero Universitaria di Pisa	Pisa		Italy
44	Ospedale Santo Stefano	Prato		Italy
45	AOU Tor Vergata	Roma		Italy
46	Azienda Ospedaliera Sant'Andrea	Roma		Italy
47	Ospedale San Carlo di Nancy	Roma		Italy
48	Ospedale San Filippo Neri ASL Roma 1	Roma		Italy
49	Ospedale Sandro Pertini	Roma		Italy
50	Ospedale Sant'Andrea	Roma		Italy
51	Policlinico Campus biomedico	Roma		Italy
52	Ospedale Santa Maria della Misericordia	Rovigo		Italy
53	Azienda Ospedaliero Universitaria Sassari	Sassari		Italy
54	Ospedale San Paolo	Savona		Italy
55	Ospedale Maria Vittoria	Torino		Italy
56	Ospedale Martini	Torino		Italy
57	Piccola casa della divina provenienza Ospedale Cottolengo	Torino		Italy
58	Ospedale Sant'Antonio Abate	Trapani		Italy
59	Ospedale San Camillo	Trento		Italy
60	AOU Trieste	Trieste		Italy
61	Ospedale Sant'andrea	Vercelli		Italy
62	Ospedale Belcolle	Viterbo		Italy

Sponsors and Collaborators

Gabriele Anania

Investigators

Principal Investigator: Gabriele Anania, Ferrara University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gabriele Anania, Prof., University Hospital of Ferrara

ClinicalTrials.gov Identifier:

NCT05943951

Other Study ID Numbers:

CoDIG-2

First Posted:

Jul 13, 2023

Last Update Posted:

Jul 13, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gabriele Anania, Prof., University Hospital of Ferrara

Right hemicolectomy

Colon cancer

Lymphadenectomy

Additional relevant MeSH terms:

Colonic Neoplasms

Lymphatic Metastasis

Study Results

No Results Posted as of Jul 13, 2023