Clinical trial NCT05943951: Italian Study on the Right Hemicolectomy: How the Lymphadenectomy is Performed
Official title: Lymphadenectomy in Right Hemicolectomy: Italian Multicenter Study (CoDIG-2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Lymph Node Metastasis
Surgical Procedure, Unspecified
Keywords: Right hemicolectomy
Colon cancer
Lymphadenectomy
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 788
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged \> 18, men and women, operated by laparoscopic/robotic or video-assisted right hemicolectomy, under election regime with diagnosis of colic adenocarcinoma in one of the centers that take part of the study After the 6 months period a total of 788 patients was enrolled in the 76 italian centers

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: the analysis of lymphadenectomy in the course of right hemciolectomy, in relation to the radicality of surgical resection that is performed
timeFrame: 6 months
Secondary outcomes:
measure: Vascular anatomical variability
timeFrame: 6 months
Other outcomes:
Locations:
city: Jesi
country: Italy
facility: Ospedale Carlo Urbani
state: Ancona
city: Acquaviva Delle Fonti
country: Italy
facility: Ospedale Generale Regionale F. Miulli
state: Bari
city: Castellana Grotte
country: Italy
facility: IRCCS Saverio de Bellis
state: Bari
city: Osio Sotto
country: Italy
facility: Policlinico San Marco Zingonia
state: Bergamo
city: Esine
country: Italy
facility: Ospedale Valcamonica
state: Brescia
city: Montichiari
country: Italy
facility: ASST Spedali Civili
state: Brescia
city: Bagno A Ripoli
country: Italy
facility: Ospedale Santa Maria Annunziata
state: Firenze
city: Legnano
country: Italy
facility: Ospedale Nuovo di Legnano
state: Milano
city: Frattamaggiore
country: Italy
facility: Ospedale San Giovanni di Dio Frattamaggiore
state: Napoli
city: Piove Di Sacco
country: Italy
facility: Ospedale Immacolata Concezione Piove di Sacco ULSS 6
state: Padova
city: Civitavecchia
country: Italy
facility: Ospedale San Paolo
state: Roma
city: Iglesias
country: Italy
facility: Ospedale CTO
state: Sud Sardegna
city: Montebelluna
country: Italy
facility: Ospedale San Valentino
state: Treviso
city: Latisana
country: Italy
facility: Ospedale di Latisana
state: Udine
city: Borgosesia
country: Italy
facility: Ospedale San Pietro e Paolo
state: Vercelli
city: Ancona
country: Italy
facility: Ospedale Umberto I
city: Andria
country: Italy
facility: Ospedale Bonomo
city: Aosta
country: Italy
facility: Ospedale Regionale U. Parini
city: Bergamo
country: Italy
facility: Policlinico Ponte San Pietro
city: Biella
country: Italy
facility: ASL Biella
city: Bologna
country: Italy
facility: IRCCS AOU Bologna, Sant'Orsola
city: Bolzano
country: Italy
facility: Ospedale centrale di Bolzano
city: Cagliari
country: Italy
facility: Azienda Ospedaliero universitaria di Cagliari
city: Cagliari
country: Italy
facility: PO Santissima Trinità ASL Cagliari
city: Catanzaro
country: Italy
facility: AOU Mater Domini Università Magna Grecia Catanzaro
city: Ferrara
country: Italy
facility: Anania Gabriele
city: Firenze
country: Italy
facility: AOU Careggi
city: Firenze
country: Italy
facility: Ospedale San Giovanni di Dio
city: Foggia
country: Italy
facility: Azienda Ospedaliero Universitaria di Foggia
city: Forlì
country: Italy
facility: Ospedale Morgagni-Pierantoni
city: L'Aquila
country: Italy
facility: P.O. San Salvatore
city: Macerata
country: Italy
facility: Ospedale civile di Macerata
city: Messina
country: Italy
facility: AO Papardo
city: Milano
country: Italy
facility: IRCCS Ca Granada Ospedale Maggiore Policlinico Milano
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Modena
country: Italy
facility: AOU Modena
city: Napoli
country: Italy
facility: AORN dei Colli - Ospedale Monaldi
city: Napoli
country: Italy
facility: AOU Federico II di Napoli
city: Napoli
country: Italy
facility: Isitituto Nazionale Tumori ICRSS Fondazione G. Pascale
city: Palermo
country: Italy
facility: Policlinico P. Giaccone
city: Pesaro
country: Italy
facility: Ospedali Riuniti Marche Nord
city: Pescara
country: Italy
facility: Ospedale Civile Santo Spirito
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria di Pisa
city: Prato
country: Italy
facility: Ospedale Santo Stefano
city: Roma
country: Italy
facility: AOU Tor Vergata
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
city: Roma
country: Italy
facility: Ospedale San Carlo di Nancy
city: Roma
country: Italy
facility: Ospedale San Filippo Neri ASL Roma 1
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Roma
country: Italy
facility: Ospedale Sant'Andrea
city: Roma
country: Italy
facility: Policlinico Campus biomedico
city: Rovigo
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Sassari
country: Italy
facility: Azienda Ospedaliero Universitaria Sassari
city: Savona
country: Italy
facility: Ospedale San Paolo
city: Torino
country: Italy
facility: Ospedale Maria Vittoria
city: Torino
country: Italy
facility: Ospedale Martini
city: Torino
country: Italy
facility: Piccola casa della divina provenienza Ospedale Cottolengo
city: Trapani
country: Italy
facility: Ospedale Sant'Antonio Abate
city: Trento
country: Italy
facility: Ospedale San Camillo
city: Trieste
country: Italy
facility: AOU Trieste
city: Vercelli
country: Italy
facility: Ospedale Sant'andrea
city: Viterbo
country: Italy
facility: Ospedale Belcolle
Study officials:
affiliation: Ferrara University Hospital
name: Gabriele Anania
role: PRINCIPAL_INVESTIGATOR
References: