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

NCT05943951 | Completed

• 1 other identifier: CoDIG-2
• Study Type: observational
• Target: 788
• Locations: 1 country
• Sites: 62

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

Conditions

Colon Cancer; Lymph Node Metastasis; Surgical Procedure, Unspecified

Keywords

Right hemicolectomy; Colon cancer; Lymphadenectomy

Outcome Measures

Primary Outcomes (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).

  6 months

Secondary Outcomes (1)

• Vascular anatomical variability

  6 months

Interventions

Right hemicolectomy PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gabriele Anania: lead

Study Sites (62)

Ospedale Carlo Urbani

Iesi, Ancona, Italy

Location

Ospedale Generale Regionale F. Miulli

Acquaviva delle Fonti, Bari, Italy

Location

IRCCS Saverio de Bellis

Castellana Grotte, Bari, Italy

Location

Policlinico San Marco Zingonia

Osio Sotto, Bergamo, Italy

Location

Ospedale Valcamonica

Esine, Brescia, Italy

Location

ASST Spedali Civili

Montichiari, Brescia, Italy

Location

Ospedale Santa Maria Annunziata

Bagno a Ripoli, Firenze, Italy

Location

Ospedale Nuovo di Legnano

Legnano, Milano, Italy

Location

Ospedale San Giovanni di Dio Frattamaggiore

Frattamaggiore, Napoli, Italy

Location

Ospedale Immacolata Concezione Piove di Sacco ULSS 6

Piove di Sacco, Padova, Italy

Location

Ospedale San Paolo

Civitavecchia, Roma, Italy

Location

Ospedale CTO

Iglesias, Sud Sardegna, Italy

Location

Ospedale San Valentino

Montebelluna, Treviso, 31044, Italy

Location

Ospedale di Latisana

Latisana, Udine, Italy

Location

Ospedale San Pietro e Paolo

Borgosesia, Vercelli, Italy

Location

Ospedale Umberto I

Ancona, Italy

Location

Ospedale Bonomo

Andria, Italy

Location

Ospedale Regionale U. Parini

Aosta, Italy

Location

Policlinico Ponte San Pietro

Bergamo, Italy

Location

ASL Biella

Biella, Italy

Location

IRCCS AOU Bologna, Sant'Orsola

Bologna, Italy

Location

Ospedale centrale di Bolzano

Bolzano, Italy

Location

Azienda Ospedaliero universitaria di Cagliari

Cagliari, Italy

Location

PO Santissima Trinità ASL Cagliari

Cagliari, Italy

Location

AOU Mater Domini Università Magna Grecia Catanzaro

Catanzaro, Italy

Location

Anania Gabriele

Ferrara, 44124, Italy

Location

AOU Careggi

Florence, Italy

Location

Ospedale San Giovanni di Dio

Florence, Italy

Location

Azienda Ospedaliero Universitaria di Foggia

Foggia, Italy

Location

Ospedale Morgagni-Pierantoni

Forlì, Italy

Location

P.O. San Salvatore

L’Aquila, Italy

Location

Ospedale civile di Macerata

Macerata, Italy

Location

AO Papardo

Messina, Italy

Location

IRCCS Ca Granada Ospedale Maggiore Policlinico Milano

Milan, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

AOU Modena

Modena, Italy

Location

AORN dei Colli - Ospedale Monaldi

Napoli, Italy

Location

AOU Federico II di Napoli

Napoli, Italy

Location

Isitituto Nazionale Tumori ICRSS Fondazione G. Pascale

Napoli, Italy

Location

Policlinico P. Giaccone

Palermo, Italy

Location

Ospedali Riuniti Marche Nord

Pesaro, 61121, Italy

Location

Ospedale Civile Santo Spirito

Pescara, Italy

Location

Azienda Ospedaliero Universitaria di Pisa

Pisa, Italy

Location

Ospedale Santo Stefano

Prato, Italy

Location

AOU Tor Vergata

Roma, Italy

Location

Azienda Ospedaliera Sant'Andrea

Roma, Italy

Location

Ospedale San Carlo di Nancy

Roma, Italy

Location

Ospedale San Filippo Neri ASL Roma 1

Roma, Italy

Location

Ospedale Sandro Pertini

Roma, Italy

Location

Ospedale Sant'Andrea

Roma, Italy

Location

Policlinico Campus biomedico

Roma, Italy

Location

Ospedale Santa Maria della Misericordia

Rovigo, Italy

Location

Azienda Ospedaliero Universitaria Sassari

Sassari, Italy

Location

Ospedale San Paolo

Savona, Italy

Location

Ospedale Maria Vittoria

Torino, Italy

Location

Ospedale Martini

Torino, Italy

Location

Piccola casa della divina provenienza Ospedale Cottolengo

Torino, Italy

Location

Ospedale Sant'Antonio Abate

Trapani, Italy

Location

Ospedale San Camillo

Trento, Italy

Location

AOU Trieste

Trieste, Italy

Location

Ospedale Sant'andrea

Vercelli, Italy

Location

Ospedale Belcolle

Viterbo, Italy

Location

Related Publications (1)

• 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.

  PMID: 38191814 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriele Anania

  Ferrara University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 13, 2023
• Study Start: April 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (62)