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Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03934151
Acronym
CoDIG
Enrollment
1225
Registered
2019-05-01
Start date
2018-03-01
Completion date
2018-12-15
Last updated
2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Gastrointestinal Anastomosis, Intestinal Anastomosis Complication

Keywords

laparoscopy, ileocolic anastomosis, right hemicolectomy

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.

Interventions

PROCEDUREintracorporeal ileocolic anastomosis

laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag

PROCEDUREextracorporeal ileocolic anastomosis

ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy

Sponsors

University Hospital of Ferrara
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anastomotic complicationsmaximum 30 daysnumber of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique
Postoperative day of discharge4 to 30 daysthe lenght of stay in hospital measured in days after right hemicolectomy with ileocolic anastomosis performed with intracorporeal or extracorporeal technique

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026