Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy

Intestinal Anastomosis Complication Clinical Trial

— CoDIG  

Official title:

Multicenter National Observational Study on Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934151
• Other study ID #: 170595
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: December 15, 2018

Study information

• Verified date: February 2019
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1225
• Est. completion date: December 15, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication of Gastrointestinal Anastomosis
• Intestinal Anastomosis Complication

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Italy	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	Firenze
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	Chirurgia d' Urgenza Careggi	Firenze
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,	Jesi
Italy	Ospedale Civile San Salvatore	L'Aquila
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	Policlinico G. Martino	Messina
Italy	"ASST NORD MILANO Ospedale Città di Sesto San Giovanni "	Milano
Italy	"ASST OVEST MILANESE - Ospedale G. Fornaroli Magenta "	Milano
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano
Italy	IEO (Istituto Europeo di Oncologia)	Milano
Italy	IRCCS Policlinico Ospedale Maggiore Milano	Milano
Italy	Ospedale Sacco	Milano
Italy	San Paolo	Milano
Italy	San Raffaele	Milano
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomotic complications	number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique	maximum 30 days
Primary	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