Complication of Gastrointestinal AnastomosisCoDIGNCT03934151
Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy
An observational study of Complication of Gastrointestinal Anastomosis and Intestinal Anastomosis Complication, run by University Hospital of Ferrara at 85 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Gastrointestinal Anastomosis, Intestinal Anastomosis Complication
- What is being tested?
- intracorporeal ileocolic anastomosis and extracorporeal ileocolic anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 1,225 participants
- Where
- 85 sitesItaly
- Study dates
- 1 Mar 2018to 15 Dec 2018
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients operated in emergency
- Pregnant women
- Right laparotomic hemicolectomy
- BMI> 35
Trial locations and contacts
85 sites in 1 country.
85 sites in 1 country
Italy85 sites
ULSS5 Polesa - Ospedale di Adria
Adria
San Lazzaro Alba
Alba
Ospedale Civile L. Bonomo
Andria
"U.Parini" di AOsta
Aosta
Ospedale C e G Mazzoni
Ascoli Piceno
Casa di Cura Villa Maria
Avellino
Ospedale di Bassano del Grappa
Bassano del Grappa
Policlinico San Marco
Bergamo
Ospedale Maggiore di Bologna
Bologna
SS. Pietro e Paolo
Borgosesia
ASST Spedali Civili
Brescia
Spedali Civili di Brescia Presidio Montichiari
Brescia
Policlinico Universitario di Monserrato - AOU Cagliari
Cagliari
Santissima Trinità
Cagliari
Aslto5 Piemonte
Chieri
Bassini
Cinisello Balsamo
U.O. Chirurgia Cles
Cles
Santa Maria dei Battuti
Conegliano
Aso Santa Croce E Carle Di Cuneo
Cuneo
Regina Montis Regalis Mondovì
Cuneo
Ospedale "E. Profili" Fabriano
Fabriano
Arcispedale Sant'Anna Ferrara
Ferrara
Istituto di chirurgia generale 1
Ferrara
Ospedale di Fidenza; AUSL Parma
Fidenza
AOU Careggi
Florence
Azienda Ospedaliera Universitaria Careggi
Florence
Chirurgia d' Urgenza Careggi
Florence
Ospedali Riuniti di Foggia
Foggia
Ospedale Morgagni-Pierantoni
Forlì
Ospedale Policlinico San Martino
Genova
Chirurgia Gorizia
Gorizia
Gualdo Tadino
Gubbio
Carlo Urbani, Jesi,
Iesi
Ospedale Civile San Salvatore
L’Aquila
Ospedale Sant'Andrea
La Spezia
Ospedale Del Delta
Lagosanto
N.S. della Mercede
Lanusei
ICOT
Latina
AAS 2 "Bassa Friulana-Isontina", Ospedale di Latisana-Palmanova
Latisana
Policlinico G. Martino
Messina
"ASST NORD MILANO Ospedale Città di Sesto San Giovanni "
Milan
"ASST OVEST MILANESE - Ospedale G. Fornaroli Magenta "
Milan
ASST Grande Ospedale Metropolitano Niguarda
Milan
IEO (Istituto Europeo di Oncologia)
Milan
IRCCS Policlinico Ospedale Maggiore Milano
Milan
Ospedale Sacco
Milan
San Paolo
Milan
San Raffaele
Milan
OCSAE
Modena
Policlinico di Modena
Modena
San Valentino
Montebelluna
A.O.U. Federico II
Naples
Int Pascale Napoli
Naples
Monaldi, AORN
Naples
San Francesco
Nuoro
Giovanni Paolo II
Olbia
San Luigi Gonzaga
Orbassano
Aoup P. Giaccone
Palermo
Città di Castello
Perugia
Ospedale Santa Maria della Misericordia
Perugia
Ospedale civile
Pescara
Pederzoli
Peschiera del Garda
Ospedale Santa Corona
Pietra Ligure
Ospedale San Jacopo
Pistoia
Azienda Ospedaliera S. Maria degli Angeli
Pordenone
Ospedale San Tommaso dei Battuti- ULSS 4 Veneto orientale
Portogruaro
Santa Maria delle Croci
Ravenna
Chirurgia Generale
Riccione
Infermi
Rimini
Azienda Ospedaliera Sant'Andrea
Roma
Azienda Ospedaliera Universitaria Policlinico "Umberto I"
Roma
Ospedale San Camillo - Forlanini
Roma
ospedale San Filippo Neri Roma
Roma
Sant'Eugenio- Asl Roma2
Roma
Azienda Ospedaliera Universitaria " San Giovanni di Dio e Ruggi d'Aragona" - Università di Salerno
Salerno
Ospedale Nostra Signora di Bonaria
San Gavino Monreale
"A.O.U. Sassari "
Sassari
Ospedale Sassuolo SPA
Sassuolo
Policlinico Le Scotte
Siena
S. Vincenzo
Taormina
Citta della Salute e della Scienza di Torino sede Molinette
Torino
Cardinale Panico
Tricase
Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale di Cattinara
Trieste
Ospedale Santa Maria della Misericordia
Udine
Sant'Andrea
Vercelli
About this study
Official title: 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
Read the 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.
- Being tested
- intracorporeal ileocolic anastomosis, extracorporeal ileocolic anastomosis
- Keywords
- laparoscopy, ileocolic anastomosis, right hemicolectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracorporeal ileocolic anastomosisProcedure or surgery
laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag
extracorporeal ileocolic anastomosisProcedure or surgery
ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy
| Study group | Role | What they receive |
|---|---|---|
| intracorporeal anastomosis | patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique Receives: Procedure: intracorporeal ileocolic anastomosis | |
| extracorporeal anastomosis | patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique Receives: Procedure: extracorporeal ileocolic anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic complications
number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique
Measured: 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
Measured: 4 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Mar 2018
- Primary completion30 Sep 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complication of Gastrointestinal AnastomosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,225 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Anania, University Hospital of Ferrara
- Investigators
- Gabriele Anania, Principal investigator, Società Italiana Chirurgia Endoscopica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934151
- Sponsor's protocol ID
- 170595
- Acronym
- CoDIG
- Status last verified
- Feb 2019
- First submitted
- 26 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: privacy
Publications
Anania G, Mascagni P, Chiozza M, Resta G, Campagnaro A, Pedon S, Silecchia G, Cuccurullo D, Bergamini C, Sica G, Nicola V, Alberti M, Ortenzi M, Reddavid R, Azzolina D; SICE CoDIG (ColonDx Italian Group). Deep learning neural network prediction of postoperative complications in patients undergoing laparoscopic right hemicolectomy with or without CME and CVL for colon cancer: insights from SICE (Societa Italiana di Chirurgia Endoscopica) CoDIG data. Tech Coloproctol. 2025 Jun 11;29(1):135. doi: 10.1007/s10151-025-03165-9.
PubMed 40498162Anania 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.
PubMed 31741153
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter National Observational Study on Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy
- ClinicalTrials.gov ID
- NCT03934151
- Acronym / sponsor ID
- CoDIG / 170595
- Keywords
- laparoscopy, ileocolic anastomosis, right hemicolectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,225 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intracorporeal anastomosis | – | Procedure: intracorporeal ileocolic anastomosispatients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique |
| extracorporeal anastomosis | – | Procedure: extracorporeal ileocolic anastomosispatients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Patients operated in emergency
- Pregnant women
- Right laparotomic hemicolectomy
- BMI> 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intracorporeal ileocolic anastomosislaparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag | Procedure or surgery | intracorporeal anastomosis |
| extracorporeal ileocolic anastomosisileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy | Procedure or surgery | extracorporeal anastomosis |
Primary outcome
Anastomotic complications
Time frame: maximum 30 days
number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Derived from this study: PubMed 40498162Anania G, Mascagni P, Chiozza M, Resta G, Campagnaro A, Pedon S, Silecchia G, Cuccurullo D, Bergamini C, Sica G, Nicola V, Alberti M, Ortenzi M, Reddavid R, Azzolina D; SICE CoDIG (ColonDx Italian Group). Deep learning neural network prediction of postoperative complications in patients undergoing laparoscopic right hemicolectomy with or without CME and CVL for colon cancer: insights from SICE (Societa Italiana di Chirurgia Endoscopica) CoDIG data. Tech Coloproctol. 2025 Jun 11;29(1):135. doi: 10.1007/s10151-025-03165-9.
- Derived from this study: PubMed 31741153Anania 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.
- Individual participant dataSharing planned: No. privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriele Anania principal investigator
Società Italiana Chirurgia Endoscopica
85 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Gastrointestinal Anastomosis and Intestinal Anastomosis Complication, run by University Hospital of Ferrara at 85 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic complications (time frame: maximum 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934151, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.