Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy
CoDIG
Multicenter National Observational Study on Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy
1 other identifier
observational
1,225
1 country
85
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2018
Shorter than P25 for all trials
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2018
CompletedFirst Submitted
Initial submission to the registry
April 26, 2019
CompletedFirst Posted
Study publicly available on registry
May 1, 2019
CompletedMay 1, 2019
February 1, 2019
7 months
April 26, 2019
April 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Anastomotic complications
number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique
maximum 30 days
Postoperative day of discharge
the lenght of stay in hospital measured in days after right hemicolectomy with ileocolic anastomosis performed with intracorporeal or extracorporeal technique
4 to 30 days
Study Arms (2)
intracorporeal anastomosis
patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique
extracorporeal anastomosis
patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique
Interventions
laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag
ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy
Eligibility Criteria
Patients affected by malignant or benign pathology of the right colon treated in italian surgical centers accredited by the Ministry of Public Health
You may qualify if:
- 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
You may not qualify if:
- Patients operated in emergency
- Pregnant women
- Right laparotomic hemicolectomy
- BMI\> 35
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (85)
ULSS5 Polesa - Ospedale di Adria
Adria, Italy
San Lazzaro Alba
Alba, Italy
Ospedale Civile L. Bonomo
Andria, Italy
"U.Parini" di AOsta
Aosta, Italy
Ospedale C e G Mazzoni
Ascoli Piceno, Italy
Casa di Cura Villa Maria
Avellino, Italy
Ospedale di Bassano del Grappa
Bassano del Grappa, Italy
Policlinico San Marco
Bergamo, Italy
Ospedale Maggiore di Bologna
Bologna, Italy
SS. Pietro e Paolo
Borgosesia, Italy
ASST Spedali Civili
Brescia, Italy
Spedali Civili di Brescia Presidio Montichiari
Brescia, Italy
Policlinico Universitario di Monserrato - AOU Cagliari
Cagliari, Italy
Santissima Trinità
Cagliari, Italy
Aslto5 Piemonte
Chieri, Italy
Bassini
Cinisello Balsamo, Italy
U.O. Chirurgia Cles
Cles, Italy
Santa Maria dei Battuti
Conegliano, Italy
Aso Santa Croce E Carle Di Cuneo
Cuneo, Italy
Regina Montis Regalis Mondovì
Cuneo, Italy
Ospedale "E. Profili" Fabriano
Fabriano, Italy
Arcispedale Sant'Anna Ferrara
Ferrara, Italy
Istituto di chirurgia generale 1
Ferrara, Italy
Ospedale di Fidenza; AUSL Parma
Fidenza, Italy
AOU Careggi
Florence, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Chirurgia d' Urgenza Careggi
Florence, Italy
Ospedali Riuniti di Foggia
Foggia, Italy
Ospedale Morgagni-Pierantoni
Forlì, Italy
Ospedale Policlinico San Martino
Genova, Italy
Chirurgia Gorizia
Gorizia, Italy
Gualdo Tadino
Gubbio, Italy
Carlo Urbani, Jesi,
Iesi, Italy
Ospedale Sant'Andrea
La Spezia, Italy
Ospedale Del Delta
Lagosanto, Italy
N.S. della Mercede
Lanusei, Italy
ICOT
Latina, Italy
AAS 2 "Bassa Friulana-Isontina", Ospedale di Latisana-Palmanova
Latisana, Italy
Ospedale Civile San Salvatore
L’Aquila, Italy
Policlinico G. Martino
Messina, Italy
"ASST NORD MILANO Ospedale Città di Sesto San Giovanni "
Milan, Italy
"ASST OVEST MILANESE - Ospedale G. Fornaroli Magenta "
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
IEO (Istituto Europeo di Oncologia)
Milan, Italy
IRCCS Policlinico Ospedale Maggiore Milano
Milan, Italy
Ospedale Sacco
Milan, Italy
San Paolo
Milan, Italy
San Raffaele
Milan, Italy
OCSAE
Modena, Italy
Policlinico di Modena
Modena, Italy
San Valentino
Montebelluna, Italy
A.O.U. Federico II
Napoli, Italy
Int Pascale Napoli
Napoli, Italy
Monaldi, AORN
Napoli, Italy
San Francesco
Nuoro, Italy
Giovanni Paolo II
Olbia, Italy
San Luigi Gonzaga
Orbassano, Italy
Aoup P. Giaccone
Palermo, Italy
Città di Castello
Perugia, Italy
Ospedale Santa Maria della Misericordia
Perugia, Italy
Ospedale civile
Pescara, Italy
Pederzoli
Peschiera del Garda, Italy
Ospedale Santa Corona
Pietra Ligure, Italy
Ospedale San Jacopo
Pistoia, Italy
Azienda Ospedaliera S. Maria degli Angeli
Pordenone, Italy
Ospedale San Tommaso dei Battuti- ULSS 4 Veneto orientale
Portogruaro, Italy
Santa Maria delle Croci
Ravenna, Italy
Chirurgia Generale
Riccione, Italy
Infermi
Rimini, Italy
Azienda Ospedaliera Sant'Andrea
Roma, Italy
Azienda Ospedaliera Universitaria Policlinico "Umberto I"
Roma, Italy
Ospedale San Camillo - Forlanini
Roma, Italy
ospedale San Filippo Neri Roma
Roma, Italy
Sant'Eugenio- Asl Roma2
Roma, Italy
Azienda Ospedaliera Universitaria " San Giovanni di Dio e Ruggi d'Aragona" - Università di Salerno
Salerno, Italy
Ospedale Nostra Signora di Bonaria
San Gavino Monreale, Italy
"A.O.U. Sassari "
Sassari, Italy
Ospedale Sassuolo SPA
Sassuolo, Italy
Policlinico Le Scotte
Siena, Italy
S. Vincenzo
Taormina, Italy
Citta della Salute e della Scienza di Torino sede Molinette
Torino, Italy
Cardinale Panico
Tricase, Italy
Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale di Cattinara
Trieste, Italy
Ospedale Santa Maria della Misericordia
Udine, Italy
Sant'Andrea
Vercelli, Italy
Related Publications (1)
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.
PMID: 31741153DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriele Anania
Società Italiana Chirurgia Endoscopica
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professore Associato
Study Record Dates
First Submitted
April 26, 2019
First Posted
May 1, 2019
Study Start
March 1, 2018
Primary Completion
September 30, 2018
Study Completion
December 15, 2018
Last Updated
May 1, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share
privacy