Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy (CoDIG)

April 30, 2019 updated by: Gabriele Anania, University Hospital of Ferrara

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Adria, Italy
        • ULSS5 Polesa - Ospedale di Adria
      • Alba, Italy
        • San Lazzaro Alba
      • Andria, Italy
        • Ospedale Civile L. Bonomo
      • Aosta, Italy
        • "U.Parini" di AOsta
      • Ascoli Piceno, Italy
        • Ospedale C e G Mazzoni
      • Avellino, Italy
        • Casa di Cura Villa Maria
      • Bassano Del Grappa, Italy
        • Ospedale di Bassano del Grappa
      • Bergamo, Italy
        • Policlinico San Marco
      • Bologna, Italy
        • Ospedale Maggiore di Bologna
      • Borgosesia, Italy
        • SS. Pietro e Paolo
      • Brescia, Italy
        • ASST Spedali Civili
      • Brescia, Italy
        • Spedali Civili di Brescia Presidio Montichiari
      • Cagliari, Italy
        • Policlinico Universitario di Monserrato - AOU Cagliari
      • Cagliari, Italy
        • Santissima Trinità
      • Chieri, Italy
        • Aslto5 Piemonte
      • Cinisello Balsamo, Italy
        • Bassini
      • Cles, Italy
        • U.O. Chirurgia Cles
      • Conegliano, Italy
        • Santa Maria dei Battuti
      • Cuneo, Italy
        • Aso Santa Croce E Carle Di Cuneo
      • Cuneo, Italy
        • Regina Montis Regalis Mondovì
      • Fabriano, Italy
        • Ospedale "E. Profili" Fabriano
      • Ferrara, Italy
        • Arcispedale Sant'Anna Ferrara
      • Ferrara, Italy
        • Istituto di chirurgia generale 1
      • Fidenza, Italy
        • Ospedale di Fidenza; AUSL Parma
      • Firenze, Italy
        • AOU Careggi
      • Firenze, Italy
        • Azienda Ospedaliera Universitaria Careggi
      • Firenze, Italy
        • Chirurgia d' Urgenza Careggi
      • Foggia, Italy
        • Ospedali Riuniti di Foggia
      • Forlì, Italy
        • Ospedale Morgagni-Pierantoni
      • Genova, Italy
        • Ospedale Policlinico San Martino
      • Gorizia, Italy
        • Chirurgia Gorizia
      • Gubbio, Italy
        • Gualdo Tadino
      • Jesi, Italy
        • Carlo Urbani, Jesi,
      • L'Aquila, Italy
        • Ospedale Civile San Salvatore
      • La Spezia, Italy
        • Ospedale Sant'Andrea
      • Lagosanto, Italy
        • Ospedale del Delta
      • Lanusei, Italy
        • N.S. della Mercede
      • Latina, Italy
        • ICOT
      • Latisana, Italy
        • AAS 2 "Bassa Friulana-Isontina", Ospedale di Latisana-Palmanova
      • Messina, Italy
        • Policlinico G. Martino
      • Milano, Italy
        • Asst Grande Ospedale Metropolitano Niguarda
      • Milano, Italy
        • "ASST NORD MILANO Ospedale Città di Sesto San Giovanni "
      • Milano, Italy
        • "ASST OVEST MILANESE - Ospedale G. Fornaroli Magenta "
      • 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
      • Modena, Italy
        • Policlinico di Modena
      • Modena, Italy
        • OCSAE
      • Montebelluna, Italy
        • San Valentino
      • Napoli, Italy
        • A.O.U. Federico II
      • Napoli, Italy
        • Int Pascale Napoli
      • Napoli, Italy
        • Monaldi, AORN
      • Nuoro, Italy
        • San Francesco
      • Olbia, Italy
        • Giovanni Paolo II
      • Orbassano, Italy
        • San Luigi Gonzaga
      • Palermo, Italy
        • AOUP P. Giaccone
      • Perugia, Italy
        • Ospedale Santa Maria Della Misericordia
      • Perugia, Italy
        • Città di Castello
      • Pescara, Italy
        • Ospedale Civile
      • Peschiera Del Garda, Italy
        • Pederzoli
      • Pietra Ligure, Italy
        • Ospedale Santa Corona
      • Pistoia, Italy
        • Ospedale San Jacopo
      • Pordenone, Italy
        • Azienda Ospedaliera S. Maria degli Angeli
      • Portogruaro, Italy
        • Ospedale San Tommaso dei Battuti- ULSS 4 Veneto orientale
      • Ravenna, Italy
        • Santa Maria delle Croci
      • Riccione, Italy
        • Chirurgia Generale
      • Rimini, Italy
        • Infermi
      • Roma, 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
      • Salerno, Italy
        • Azienda Ospedaliera Universitaria " San Giovanni di Dio e Ruggi d'Aragona" - Università di Salerno
      • San Gavino Monreale, Italy
        • Ospedale Nostra Signora di Bonaria
      • Sassari, Italy
        • "A.O.U. Sassari "
      • Sassuolo, Italy
        • Ospedale Sassuolo SPA
      • Siena, Italy
        • Policlinico Le Scotte
      • Taormina, Italy
        • S. Vincenzo
      • Torino, Italy
        • Citta della Salute e della Scienza di Torino sede Molinette
      • Tricase, Italy
        • Cardinale Panico
      • Trieste, Italy
        • Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale di Cattinara
      • Udine, Italy
        • Ospedale Santa Maria Della Misericordia
      • Vercelli, Italy
        • Sant'Andrea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
intracorporeal anastomosis
patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique
Procedure: 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
Procedure: extracorporeal ileocolic anastomosis
ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anastomotic complications
Time Frame: maximum 30 days
number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique
maximum 30 days
Postoperative day of discharge
Time Frame: 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
4 to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

December 15, 2018

Study Registration Dates

First Submitted

April 26, 2019

First Submitted That Met QC Criteria

April 30, 2019

First Posted (Actual)

May 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 170595

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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