Italian Study on the Right Hemicolectomy: How the Lymphadenectomy is Performed
- Conditions
- Lymph Node MetastasisColon CancerSurgical 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 788
-
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.
- 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 Sant'Andrea
🇮🇹Roma, Italy
Ospedale Nuovo di Legnano
🇮🇹Legnano, Milano, Italy
IRCCS Saverio de Bellis
🇮🇹Castellana Grotte, Bari, Italy
Ospedale San Valentino
🇮🇹Montebelluna, Treviso, Italy
Ospedale San Pietro e Paolo
🇮🇹Borgosesia, Vercelli, Italy
AOU Trieste
🇮🇹Trieste, Italy
Policlinico San Marco Zingonia
🇮🇹Osio Sotto, Bergamo, Italy
Ospedale Santa Maria Annunziata
🇮🇹Bagno A Ripoli, Firenze, Italy
Ospedale San Giovanni di Dio Frattamaggiore
🇮🇹Frattamaggiore, Napoli, Italy
Ospedale Immacolata Concezione Piove di Sacco ULSS 6
🇮🇹Piove Di Sacco, Padova, Italy
Ospedale Generale Regionale F. Miulli
🇮🇹Acquaviva Delle Fonti, Bari, Italy
Ospedale San Paolo
🇮🇹Savona, Italy
Ospedale CTO
🇮🇹Iglesias, Sud Sardegna, Italy
Ospedale Umberto I
🇮🇹Ancona, Italy
Ospedale Bonomo
🇮🇹Andria, Italy
Ospedale Regionale U. Parini
🇮🇹Aosta, Italy
Ospedale Morgagni-Pierantoni
🇮🇹Forlì, Italy
AOU Modena
🇮🇹Modena, 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
🇮🇹Firenze, Italy
Ospedale San Giovanni di Dio
🇮🇹Firenze, Italy
Azienda Ospedaliero Universitaria di Foggia
🇮🇹Foggia, 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
🇮🇹Milano, Italy
AOU Federico II di Napoli
🇮🇹Napoli, Italy
Ospedali Riuniti Marche Nord
🇮🇹Pesaro, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
AORN dei Colli - Ospedale Monaldi
🇮🇹Napoli, Italy
Policlinico P. Giaccone
🇮🇹Palermo, Italy
Ospedale Civile Santo Spirito
🇮🇹Pescara, Italy
Isitituto Nazionale Tumori ICRSS Fondazione G. Pascale
🇮🇹Napoli, Italy
Ospedale Santo Stefano
🇮🇹Prato, Italy
Azienda Ospedaliero Universitaria di Pisa
🇮🇹Pisa, Italy
Ospedale San Carlo di Nancy
🇮🇹Roma, Italy
AOU Tor Vergata
🇮🇹Roma, Italy
Azienda Ospedaliera Sant'Andrea
🇮🇹Roma, Italy
Ospedale San Filippo Neri ASL Roma 1
🇮🇹Roma, Italy
Ospedale Sandro Pertini
🇮🇹Roma, Italy
Policlinico Campus biomedico
🇮🇹Roma, Italy
Ospedale Santa Maria della Misericordia
🇮🇹Rovigo, Italy
Azienda Ospedaliero Universitaria Sassari
🇮🇹Sassari, 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
Ospedale Sant'andrea
🇮🇹Vercelli, Italy
Ospedale Belcolle
🇮🇹Viterbo, Italy
Ospedale Valcamonica
🇮🇹Esine, Brescia, Italy
Ospedale Carlo Urbani
🇮🇹Jesi, Ancona, Italy
ASST Spedali Civili
🇮🇹Montichiari, Brescia, Italy
Ospedale di Latisana
🇮🇹Latisana, Udine, Italy