Intracorporeal Versus Extracorporeal Technique for Ileocolic Anastomosis in Laparoscopic Right Hemicolectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Complication of Gastrointestinal Anastomosis, Intestinal Anastomosis Complication

Intervention / Treatment
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* Procedure: intracorporeal ileocolic anastomosis
* Procedure: extracorporeal ileocolic anastomosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intracorporeal anastomosis<br>patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with intracorporeal technique | Procedure: intracorporeal ileocolic anastomosis<br>* laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag<br>|
| extracorporeal anastomosis<br>patients who underwent elective right hemicolectomy whose ileocolic anastomosis was performed with extracorporeal technique | Procedure: extracorporeal ileocolic anastomosis<br>* ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic complications | number of anastomotic complications after right hemicolectomy when ileocolic anastomosis is performed with intracorporeal or extracorporeal technique | 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 | 4 to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, ileocolic anastomosis, right hemicolectomy