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Colon CancerCoDIG-2NCT05943951

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

An observational study of Colon Cancer and Lymph Node Metastasis, run by Gabriele Anania at 62 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 95 years
What is being tested?
Right hemicolectomy
Type of treatment
Surgery or procedure
How many people
788 participants
Where
62 sitesItaly
Study dates
1 Apr 2022to 30 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

62 sites in 1 country.

62 sites in 1 country

Italy62 sites

  • Ospedale Generale Regionale F. Miulli

    Acquaviva delle Fonti, Bari

  • Ospedale Umberto I

    Ancona

  • Ospedale Bonomo

    Andria

  • Ospedale Regionale U. Parini

    Aosta

  • Ospedale Santa Maria Annunziata

    Bagno a Ripoli, Firenze

  • Policlinico Ponte San Pietro

    Bergamo

  • ASL Biella

    Biella

  • IRCCS AOU Bologna, Sant'Orsola

    Bologna

  • Ospedale centrale di Bolzano

    Bolzano

  • Ospedale San Pietro e Paolo

    Borgosesia, Vercelli

  • Azienda Ospedaliero universitaria di Cagliari

    Cagliari

  • PO Santissima Trinità ASL Cagliari

    Cagliari

  • IRCCS Saverio de Bellis

    Castellana Grotte, Bari

  • AOU Mater Domini Università Magna Grecia Catanzaro

    Catanzaro

  • Ospedale San Paolo

    Civitavecchia, Roma

  • Ospedale Valcamonica

    Esine, Brescia

  • Anania Gabriele

    Ferrara, 44124

  • AOU Careggi

    Florence

  • Ospedale San Giovanni di Dio

    Florence

  • Azienda Ospedaliero Universitaria di Foggia

    Foggia

  • Ospedale Morgagni-Pierantoni

    Forlì

  • Ospedale San Giovanni di Dio Frattamaggiore

    Frattamaggiore, Napoli

  • Ospedale Carlo Urbani

    Iesi, Ancona

  • Ospedale CTO

    Iglesias, Sud Sardegna

  • P.O. San Salvatore

    L’Aquila

  • Ospedale di Latisana

    Latisana, Udine

  • Ospedale Nuovo di Legnano

    Legnano, Milano

  • AO Papardo

    Messina

  • IRCCS Ca Granada Ospedale Maggiore Policlinico Milano

    Milan

  • Ospedale San Raffaele

    Milan

  • AOU Modena

    Modena

  • Ospedale San Valentino

    Montebelluna, Treviso, 31044

  • ASST Spedali Civili

    Montichiari, Brescia

  • AORN dei Colli - Ospedale Monaldi

    Naples

  • AOU Federico II di Napoli

    Naples

  • Isitituto Nazionale Tumori ICRSS Fondazione G. Pascale

    Naples

  • Policlinico San Marco Zingonia

    Osio Sotto, Bergamo

  • Policlinico P. Giaccone

    Palermo

  • Ospedali Riuniti Marche Nord

    Pesaro, 61121

  • Ospedale Civile Santo Spirito

    Pescara

  • Ospedale Immacolata Concezione Piove di Sacco ULSS 6

    Piove di Sacco, Padova

  • Azienda Ospedaliero Universitaria di Pisa

    Pisa

  • Ospedale Santo Stefano

    Prato

  • Ospedale civile di Macerata

    Province of Macerata

  • AOU Tor Vergata

    Roma

  • Azienda Ospedaliera Sant'Andrea

    Roma

  • Ospedale San Carlo di Nancy

    Roma

  • Ospedale San Filippo Neri ASL Roma 1

    Roma

  • Ospedale Sandro Pertini

    Roma

  • Ospedale Sant'Andrea

    Roma

  • Policlinico Campus biomedico

    Roma

  • Ospedale Santa Maria della Misericordia

    Rovigo

  • Azienda Ospedaliero Universitaria Sassari

    Sassari

  • Ospedale San Paolo

    Savona

  • Ospedale Maria Vittoria

    Torino

  • Ospedale Martini

    Torino

  • Piccola casa della divina provenienza Ospedale Cottolengo

    Torino

  • Ospedale Sant'Antonio Abate

    Trapani

  • Ospedale San Camillo

    Trento

  • AOU Trieste

    Trieste

  • Ospedale Sant'andrea

    Vercelli

  • Ospedale Belcolle

    Viterbo

Other trials in Italy

About this study

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

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

Read the 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.

Being tested
Right hemicolectomy
Keywords
Right hemicolectomy, Colon cancer, Lymphadenectomy
Medical subject headings
Colonic Neoplasms, Lymphatic Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Right hemicolectomyProcedure or surgery

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the analysis of lymphadenectomy in the course of right hemciolectomy, in relation to the radicality of surgical resection that is performed

    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).

    Measured: 6 months

Secondary outcomes (1)

  1. Vascular anatomical variability

    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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2023
  2. Study start1 Apr 2022
  3. Primary completion30 Sep 2022
  4. Study completion30 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
788 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05943951
Sponsor's protocol ID
CoDIG-2
Acronym
CoDIG-2
Status last verified
Jul 2023
First submitted
27 Jun 2023
Last updated
13 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: privacy

Publications

  • Anania G, Chiozza M, Campagnaro A, Bagolini F, Resta G, Azzolina D, Silecchia G, Cirocchi R, Agrusa A, Cuccurullo D, Guerrieri M; SICE CoDIG (ColonDx Italian Group). Laparoscopic right hemicolectomy: a SICE (Societa Italiana di Chirurgia Endoscopica e Nuove tecnologie) network prospective study on the approach to right colon lymphadenectomy in Italy: is there a standard?-CoDIG 2 (ColonDx Italian Group). Surg Endosc. 2024 Mar;38(3):1432-1441. doi: 10.1007/s00464-023-10607-8. Epub 2024 Jan 8.

    PubMed 38191814

Questions about this trial

What is this clinical trial studying?

An observational study of Colon Cancer and Lymph Node Metastasis, run by Gabriele Anania at 62 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the analysis of lymphadenectomy in the course of right hemciolectomy, in relation to the radicality of surgical resection that is performed (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05943951, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.

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