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

NCT ID: NCT05943951

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 788 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-10-30

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.

Conditions

Colon Cancer; Lymph Node Metastasis; Surgical Procedure, Unspecified

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Right hemicolectomy

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gabriele Anania

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Anania

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gabriele Anania

Role: PRINCIPAL_INVESTIGATOR

Ferrara University Hospital

Locations

Ospedale Carlo Urbani

Iesi, Ancona, Italy

Ospedale Generale Regionale F. Miulli

Acquaviva delle Fonti, Bari, Italy

IRCCS Saverio de Bellis

Castellana Grotte, Bari, Italy

Policlinico San Marco Zingonia

Osio Sotto, Bergamo, Italy

Ospedale Valcamonica

Esine, Brescia, Italy

ASST Spedali Civili

Montichiari, Brescia, Italy

Ospedale Santa Maria Annunziata

Bagno a Ripoli, Firenze, Italy

Ospedale Nuovo di Legnano

Legnano, Milano, Italy

Ospedale San Giovanni di Dio Frattamaggiore

Frattamaggiore, Napoli, Italy

Ospedale Immacolata Concezione Piove di Sacco ULSS 6

Piove di Sacco, Padova, Italy

Ospedale San Paolo

Civitavecchia, Roma, Italy

Ospedale CTO

Iglesias, Sud Sardegna, Italy

Ospedale San Valentino

Montebelluna, Treviso, Italy

Ospedale di Latisana

Latisana, Udine, Italy

Ospedale San Pietro e Paolo

Borgosesia, Vercelli, Italy

Ospedale Umberto I

Ancona, , Italy

Ospedale Bonomo

Andria, , Italy

Ospedale Regionale U. Parini

Aosta, , Italy

Policlinico Ponte San Pietro

Bergamo, , Italy

ASL Biella

Biella, , Italy

IRCCS AOU Bologna, Sant'Orsola

Bologna, , Italy

Ospedale centrale di Bolzano

Bolzano, , Italy

Azienda Ospedaliero universitaria di Cagliari

Cagliari, , Italy

PO Santissima Trinità ASL Cagliari

Cagliari, , Italy

AOU Mater Domini Università Magna Grecia Catanzaro

Catanzaro, , Italy

Anania Gabriele

Ferrara, , Italy

AOU Careggi

Florence, , Italy

Ospedale San Giovanni di Dio

Florence, , Italy

Azienda Ospedaliero Universitaria di Foggia

Foggia, , Italy

Ospedale Morgagni-Pierantoni

Forlì, , Italy

P.O. San Salvatore

L’Aquila, , Italy

Ospedale civile di Macerata

Macerata, , Italy

AO Papardo

Messina, , Italy

IRCCS Ca Granada Ospedale Maggiore Policlinico Milano

Milan, , Italy

Ospedale San Raffaele

Milan, , Italy

AOU Modena

Modena, , Italy

AORN dei Colli - Ospedale Monaldi

Napoli, , Italy

AOU Federico II di Napoli

Napoli, , Italy

Isitituto Nazionale Tumori ICRSS Fondazione G. Pascale

Napoli, , Italy

Policlinico P. Giaccone

Palermo, , Italy

Ospedali Riuniti Marche Nord

Pesaro, , Italy

Ospedale Civile Santo Spirito

Pescara, , Italy

Azienda Ospedaliero Universitaria di Pisa

Pisa, , Italy

Ospedale Santo Stefano

Prato, , Italy

AOU Tor Vergata

Roma, , Italy

Azienda Ospedaliera Sant'Andrea

Roma, , Italy

Ospedale San Carlo di Nancy

Roma, , Italy

Ospedale San Filippo Neri ASL Roma 1

Roma, , Italy

Ospedale Sandro Pertini

Roma, , Italy

Ospedale Sant'Andrea

Roma, , Italy

Policlinico Campus biomedico

Roma, , Italy

Ospedale Santa Maria della Misericordia

Rovigo, , Italy

Azienda Ospedaliero Universitaria Sassari

Sassari, , Italy

Ospedale San Paolo

Savona, , Italy

Ospedale Maria Vittoria

Torino, , Italy

Ospedale Martini

Torino, , Italy

Piccola casa della divina provenienza Ospedale Cottolengo

Torino, , Italy

Ospedale Sant'Antonio Abate

Trapani, , Italy

Ospedale San Camillo

Trento, , Italy

AOU Trieste

Trieste, , Italy

Ospedale Sant'andrea

Vercelli, , Italy

Ospedale Belcolle

Viterbo, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 38191814 (View on PubMed)

Other Identifiers

CoDIG-2

Identifier Type: -

Identifier Source: org_study_id