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

University Hospital of Ferrara

Status: Completed

Conditions: Intestinal Anastomosis Complication; Complication of Gastrointestinal Anastomosis

Treatments: Procedure: extracorporeal ileocolic anastomosis; Procedure: intracorporeal ileocolic anastomosis

Study type: Observational

Funder types: Other

Identifiers

NCT03934151

170595

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,225 participants in 2 patient groups

intracorporeal anastomosis

Description:

patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique

Treatment:

Procedure: intracorporeal ileocolic anastomosis

extracorporeal anastomosis

Description:

patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique

Treatment:

Procedure: extracorporeal ileocolic anastomosis