NCT03934151

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
• Phase: —
• Study type: Observational
• Enrollment: 1,225 (actual)
• Sponsor: University Hospital of Ferrara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Complication of Gastrointestinal Anastomosis
• Intestinal Anastomosis Complication

Interventions

Type	Name	Description
PROCEDURE	intracorporeal ileocolic anastomosis	laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag
PROCEDURE	extracorporeal ileocolic anastomosis	ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-09-30
• Completion: 2018-12-15
• First posted: 2019-05-01
• Last updated: 2019-05-01

Locations

85 sites across 1 country: Italy