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

Completed

• Conditions: Lymph Node Metastasis; Colon Cancer; Surgical Procedure, Unspecified

• Registration Number: NCT05943951
• Lead Sponsor: Gabriele Anania

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.

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-30
• Study First Submitted: 2023-06-27
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-10
• Last Update Submitted: 2023-07-10
• Study First Posted: 2023-07-13
• Last Update Posted: 2023-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 788

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (61)

Ospedale Carlo Urbani; 🇮🇹 Jesi, 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

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