Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy

Completed

• Conditions: Complication of Gastrointestinal Anastomosis; Intestinal Anastomosis Complication
• Interventions: Procedure: intracorporeal ileocolic anastomosis; Procedure: extracorporeal ileocolic anastomosis

• Registration Number: NCT03934151
• Lead Sponsor: University Hospital of Ferrara

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.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-09-30
• Study Completion: 2018-12-15
• Status Verified: 2019-02
• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-04-30
• Last Update Submitted: 2019-04-30
• Study First Posted: 2019-05-01
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1225

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intracorporeal anastomosis	intracorporeal ileocolic anastomosis	patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique
extracorporeal anastomosis	extracorporeal ileocolic anastomosis	patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique

Primary Outcome Measures

Name	Time	Method
Postoperative day of discharge	4 to 30 days	the lenght of stay in hospital measured in days after right hemicolectomy with ileocolic anastomosis performed with intracorporeal or extracorporeal technique
Anastomotic complications	maximum 30 days	number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique

Trial Locations

Locations (84)

SS. Pietro e Paolo; 🇮🇹 Borgosesia, Italy

ASST Spedali Civili; 🇮🇹 Brescia, Italy

Policlinico Universitario di Monserrato - AOU Cagliari; 🇮🇹 Cagliari, Italy

Santissima Trinità; 🇮🇹 Cagliari, Italy

Bassini; 🇮🇹 Cinisello Balsamo, Italy

U.O. Chirurgia Cles; 🇮🇹 Cles, Italy

Aso Santa Croce E Carle Di Cuneo; 🇮🇹 Cuneo, 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

Gualdo Tadino; 🇮🇹 Gubbio, Italy

Int Pascale Napoli; 🇮🇹 Napoli, Italy

Giovanni Paolo II; 🇮🇹 Olbia, Italy

Ospedale Santa Maria della Misericordia; 🇮🇹 Udine, 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

Infermi; 🇮🇹 Rimini, Italy

Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale di Cattinara; 🇮🇹 Trieste, Italy

Ospedale di Bassano del Grappa; 🇮🇹 Bassano Del Grappa, Italy

Aslto5 Piemonte; 🇮🇹 Chieri, Italy

Casa di Cura Villa Maria; 🇮🇹 Avellino, Italy

Ospedale Maggiore di Bologna; 🇮🇹 Bologna, Italy

Spedali Civili di Brescia Presidio Montichiari; 🇮🇹 Brescia, Italy

Policlinico San Marco; 🇮🇹 Bergamo, Italy

San Lazzaro Alba; 🇮🇹 Alba, Italy

"U.Parini" di AOsta; 🇮🇹 Aosta, Italy

Ospedale C e G Mazzoni; 🇮🇹 Ascoli Piceno, Italy

Santa Maria dei Battuti; 🇮🇹 Conegliano, Italy

Regina Montis Regalis Mondovì; 🇮🇹 Cuneo, Italy

Ospedale Del Delta; 🇮🇹 Lagosanto, Italy

Ospedale "E. Profili" Fabriano; 🇮🇹 Fabriano, Italy

Ospedali Riuniti di Foggia; 🇮🇹 Foggia, Italy

Chirurgia Gorizia; 🇮🇹 Gorizia, Italy

Ospedale Sant'Andrea; 🇮🇹 La Spezia, Italy

Policlinico G. Martino; 🇮🇹 Messina, Italy

"ASST OVEST MILANESE - Ospedale G. Fornaroli Magenta "; 🇮🇹 Milano, Italy

Policlinico Le Scotte; 🇮🇹 Siena, Italy

ICOT; 🇮🇹 Latina, Italy

Città di Castello; 🇮🇹 Perugia, Italy

Azienda Ospedaliera Universitaria Policlinico "Umberto I"; 🇮🇹 Roma, Italy

Azienda Ospedaliera Universitaria " San Giovanni di Dio e Ruggi d'Aragona" - Università di Salerno; 🇮🇹 Salerno, Italy

"A.O.U. Sassari "; 🇮🇹 Sassari, Italy

Ospedale San Camillo - Forlanini; 🇮🇹 Roma, Italy

San Luigi Gonzaga; 🇮🇹 Orbassano, Italy

Ospedale Sassuolo SPA; 🇮🇹 Sassuolo, Italy

Ospedale Nostra Signora di Bonaria; 🇮🇹 San Gavino Monreale, Italy

Citta della Salute e della Scienza di Torino sede Molinette; 🇮🇹 Torino, Italy

Sant'Andrea; 🇮🇹 Vercelli, Italy

S. Vincenzo; 🇮🇹 Taormina, Italy

Cardinale Panico; 🇮🇹 Tricase, Italy

ospedale San Filippo Neri Roma; 🇮🇹 Roma, Italy

Sant'Eugenio- Asl Roma2; 🇮🇹 Roma, Italy

Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Firenze, Italy

Chirurgia d' Urgenza Careggi; 🇮🇹 Firenze, Italy

IEO (Istituto Europeo di Oncologia); 🇮🇹 Milano, Italy

ULSS5 Polesa - Ospedale di Adria; 🇮🇹 Adria, Italy

Ospedale Civile L. Bonomo; 🇮🇹 Andria, Italy

Ospedale Morgagni-Pierantoni; 🇮🇹 Forlì, Italy

Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

Carlo Urbani, Jesi,; 🇮🇹 Jesi, Italy

Ospedale Civile San Salvatore; 🇮🇹 L'Aquila, Italy

AAS 2 "Bassa Friulana-Isontina", Ospedale di Latisana-Palmanova; 🇮🇹 Latisana, Italy

N.S. della Mercede; 🇮🇹 Lanusei, Italy

"ASST NORD MILANO Ospedale Città di Sesto San Giovanni "; 🇮🇹 Milano, Italy

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Italy

Ospedale Sacco; 🇮🇹 Milano, Italy

San Paolo; 🇮🇹 Milano, Italy

San Raffaele; 🇮🇹 Milano, Italy

IRCCS Policlinico Ospedale Maggiore Milano; 🇮🇹 Milano, Italy

OCSAE; 🇮🇹 Modena, Italy

San Valentino; 🇮🇹 Montebelluna, Italy

San Francesco; 🇮🇹 Nuoro, Italy

Policlinico di Modena; 🇮🇹 Modena, Italy

A.O.U. Federico II; 🇮🇹 Napoli, Italy

Monaldi, AORN; 🇮🇹 Napoli, Italy

Aoup P. Giaccone; 🇮🇹 Palermo, Italy

Pederzoli; 🇮🇹 Peschiera Del Garda, Italy

Ospedale civile; 🇮🇹 Pescara, Italy

Santa Maria delle Croci; 🇮🇹 Ravenna, Italy

Azienda Ospedaliera Sant'Andrea; 🇮🇹 Roma, Italy

Chirurgia Generale; 🇮🇹 Riccione, Italy