Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy
NCT ID: NCT03934151
Last Updated: 2019-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1225 participants
OBSERVATIONAL
2018-03-01
2018-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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intracorporeal anastomosis
patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique
intracorporeal ileocolic anastomosis
laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag
extracorporeal anastomosis
patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique
extracorporeal ileocolic anastomosis
ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy
Interventions
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intracorporeal ileocolic anastomosis
laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag
extracorporeal ileocolic anastomosis
ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnant women
* Right laparotomic hemicolectomy
* BMI\> 35
18 Years
ALL
No
Sponsors
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University Hospital of Ferrara
OTHER
Responsible Party
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Gabriele Anania
Professore Associato
Principal Investigators
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Gabriele Anania
Role: PRINCIPAL_INVESTIGATOR
Società Italiana Chirurgia Endoscopica
Locations
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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
Countries
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References
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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.
Other Identifiers
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170595
Identifier Type: -
Identifier Source: org_study_id
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