Clinical trial NCT03934151: Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy
Official title: Multicenter National Observational Study on Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Gastrointestinal Anastomosis
Intestinal Anastomosis Complication
Keywords: laparoscopy
ileocolic anastomosis
right hemicolectomy
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 1225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by malignant or benign pathology of the right colon treated in italian surgical centers accredited by the Ministry of Public Health

Brief summary: The aim of the study is to analyze the postoperative complication rate of intracorporeal versus extracorporeal anastomotic technique in laparoscopic or video assisted right hemicolectomy for malignant and benign neoplasms . 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: CoDIG is a cohort, observational, prospective, multi-centric national study about ileo-colic anastomosis performing with EC or IC Technique during right laparoscopic hemicolectomy.

The observational period lasts from march 2018 and September 2018. The promoter of the study is "Istituto di Chirurgia Generale 1" of Ferrara University Hospital.

135 Italian Hospitals, accredited by Health Ministry, have been contacted via e-mail and all data was compiled into a web accessible SICE database, 85 Italian clinical centres, with demonstrated experience in colorectal laparoscopic surgery, have joined the study.

Every centre was asked not to change its surgical habits concerning the technologies used, the surgical approach, the anastomotic method, the post-operative management.

Every patient involved into the study was asked to sign a consent form in order to the Helsinki Declaration.

Eligibility criteria: Inclusion Criteria:

* Patients and/or legal guardians exhaustively informed by the investigator, and who have voluntarily provided written informed consent or, when unable to read and/or write, verbal consent put into writing by a third person
* Patients who underwent elective laparoscopic or video assisted right hemicolectomy at U.O. General and Thoracic Surgery for malignant or bening pathology.
* Patients who had prior chemotherapy and radiotherapy

Exclusion Criteria:

* Patients operated in emergency
* Pregnant women
* Right laparotomic hemicolectomy
* BMI\> 35

Primary outcomes:
measure: Anastomotic complications
timeFrame: maximum 30 days
measure: Postoperative day of discharge
timeFrame: 4 to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Adria
country: Italy
facility: ULSS5 Polesa - Ospedale di Adria
city: Alba
country: Italy
facility: San Lazzaro Alba
city: Andria
country: Italy
facility: Ospedale Civile L. Bonomo
city: Aosta
country: Italy
facility: "U.Parini" di AOsta
city: Ascoli Piceno
country: Italy
facility: Ospedale C e G Mazzoni
city: Avellino
country: Italy
facility: Casa di Cura Villa Maria
city: Bassano Del Grappa
country: Italy
facility: Ospedale di Bassano del Grappa
city: Bergamo
country: Italy
facility: Policlinico San Marco
city: Bologna
country: Italy
facility: Ospedale Maggiore di Bologna
city: Borgosesia
country: Italy
facility: SS. Pietro e Paolo
city: Brescia
country: Italy
facility: ASST Spedali Civili
city: Brescia
country: Italy
facility: Spedali Civili di Brescia Presidio Montichiari
city: Cagliari
country: Italy
facility: Policlinico Universitario di Monserrato - AOU Cagliari
city: Cagliari
country: Italy
facility: Santissima Trinità
city: Chieri
country: Italy
facility: Aslto5 Piemonte
city: Cinisello Balsamo
country: Italy
facility: Bassini
city: Cles
country: Italy
facility: U.O. Chirurgia Cles
city: Conegliano
country: Italy
facility: Santa Maria dei Battuti
city: Cuneo
country: Italy
facility: Aso Santa Croce E Carle Di Cuneo
city: Cuneo
country: Italy
facility: Regina Montis Regalis Mondovì
city: Fabriano
country: Italy
facility: Ospedale "E. Profili" Fabriano
city: Ferrara
country: Italy
facility: Arcispedale Sant'Anna Ferrara
city: Ferrara
country: Italy
facility: Istituto di chirurgia generale 1
city: Fidenza
country: Italy
facility: Ospedale di Fidenza; AUSL Parma
city: Firenze
country: Italy
facility: AOU Careggi
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Firenze
country: Italy
facility: Chirurgia d' Urgenza Careggi
city: Foggia
country: Italy
facility: Ospedali Riuniti di Foggia
city: Forlì
country: Italy
facility: Ospedale Morgagni-Pierantoni
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Gorizia
country: Italy
facility: Chirurgia Gorizia
city: Gubbio
country: Italy
facility: Gualdo Tadino
city: Jesi
country: Italy
facility: Carlo Urbani, Jesi,
city: L'Aquila
country: Italy
facility: Ospedale Civile San Salvatore
city: La Spezia
country: Italy
facility: Ospedale Sant'Andrea
city: Lagosanto
country: Italy
facility: Ospedale Del Delta
city: Lanusei
country: Italy
facility: N.S. della Mercede
city: Latina
country: Italy
facility: ICOT
city: Latisana
country: Italy
facility: AAS 2 "Bassa Friulana-Isontina", Ospedale di Latisana-Palmanova
city: Messina
country: Italy
facility: Policlinico G. Martino
city: Milano
country: Italy
facility: "ASST NORD MILANO Ospedale Città di Sesto San Giovanni "
city: Milano
country: Italy
facility: "ASST OVEST MILANESE - Ospedale G. Fornaroli Magenta "
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Milano
country: Italy
facility: IEO (Istituto Europeo di Oncologia)
city: Milano
country: Italy
facility: IRCCS Policlinico Ospedale Maggiore Milano
city: Milano
country: Italy
facility: Ospedale Sacco
city: Milano
country: Italy
facility: San Paolo
city: Milano
country: Italy
facility: San Raffaele
city: Modena
country: Italy
facility: OCSAE
city: Modena
country: Italy
facility: Policlinico di Modena
city: Montebelluna
country: Italy
facility: San Valentino
city: Napoli
country: Italy
facility: A.O.U. Federico II
city: Napoli
country: Italy
facility: Int Pascale Napoli
city: Napoli
country: Italy
facility: Monaldi, AORN
city: Nuoro
country: Italy
facility: San Francesco
city: Olbia
country: Italy
facility: Giovanni Paolo II
city: Orbassano
country: Italy
facility: San Luigi Gonzaga
city: Palermo
country: Italy
facility: Aoup P. Giaccone
city: Perugia
country: Italy
facility: Città di Castello
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Pescara
country: Italy
facility: Ospedale civile
city: Peschiera Del Garda
country: Italy
facility: Pederzoli
city: Pietra Ligure
country: Italy
facility: Ospedale Santa Corona
city: Pistoia
country: Italy
facility: Ospedale San Jacopo
city: Pordenone
country: Italy
facility: Azienda Ospedaliera S. Maria degli Angeli
city: Portogruaro
country: Italy
facility: Ospedale San Tommaso dei Battuti- ULSS 4 Veneto orientale
city: Ravenna
country: Italy
facility: Santa Maria delle Croci
city: Riccione
country: Italy
facility: Chirurgia Generale
city: Rimini
country: Italy
facility: Infermi
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico "Umberto I"
city: Roma
country: Italy
facility: Ospedale San Camillo - Forlanini
city: Roma
country: Italy
facility: ospedale San Filippo Neri Roma
city: Roma
country: Italy
facility: Sant'Eugenio- Asl Roma2
city: Salerno
country: Italy
facility: Azienda Ospedaliera Universitaria " San Giovanni di Dio e Ruggi d'Aragona" - Università di Salerno
city: San Gavino Monreale
country: Italy
facility: Ospedale Nostra Signora di Bonaria
city: Sassari
country: Italy
facility: "A.O.U. Sassari "
city: Sassuolo
country: Italy
facility: Ospedale Sassuolo SPA
city: Siena
country: Italy
facility: Policlinico Le Scotte
city: Taormina
country: Italy
facility: S. Vincenzo
city: Torino
country: Italy
facility: Citta della Salute e della Scienza di Torino sede Molinette
city: Tricase
country: Italy
facility: Cardinale Panico
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale di Cattinara
city: Udine
country: Italy
facility: Ospedale Santa Maria della Misericordia
city: Vercelli
country: Italy
facility: Sant'Andrea
Study officials:
affiliation: Società Italiana Chirurgia Endoscopica
name: Gabriele Anania
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anania G, Agresta F, Artioli E, Rubino S, Resta G, Vettoretto N, Petz WL, Bergamini C, Arezzo A, Valpiani G, Morotti C, Silecchia G; SICE CoDIG (Colon Dx Italian Group). Laparoscopic right hemicolectomy: the SICE (Societa Italiana di Chirurgia Endoscopica e Nuove Tecnologie) network prospective trial on 1225 cases comparing intra corporeal versus extra corporeal ileo-colic side-to-side anastomosis. Surg Endosc. 2020 Nov;34(11):4788-4800. doi: 10.1007/s00464-019-07255-2. Epub 2019 Nov 18.