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This is a nationwide prospective observational study to assess the overall clinical anastomotic leakage rate after right hemicolectomy for cancer, to detect the independent risk factors for AL, and to develop a clinical prediction model to estimates of the probability of the occurrence of an AL after surgery. Since this is a multicenter prospective study, the Division of Surgical Oncology and Digestive Surgery from the University of Turin, Department of Oncology, AOU San Luigi Gonzaga di Orbassano will be the Coordinator Center of the study, Ethics committee approves will be requested before the implementation of this study.
Italian high-volume colorectal surgery centers members of SICO (The Italian Society of Oncological Surgery) have agreed to participate as collaborators of this study, notification and revision from their local ethics committee will be requested as well. A certified general surgeon with a large experience in the preoperative, operative, and postoperative management of patients with colorectal cancer has been identified to coordinate the study in each center. Id information of the potential collaborators is specified in the section "Trial Setting". Once the study is activated, eligible patients (or a representative) must provide written, informed consent before any study procedures occur. No intervention or modification of the habitual clinical practice is planned All data will enter into a database provided by the promoting center. There are three main sections of data collection for each patient:
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| Measure | Description | Time Frame |
|---|---|---|
| overall rate of AL | defined as the total cases of patients with clinical signs or symptoms of AL (pain, fever, tachycardia, peritonitis, feculent or enteric drainage, purulent drainage, postoperative ileus, abscess, septicemia, and/or organ failure), any radiological findings suggestive of AL (fluid collections, gas containing collections at CT scan) or intraoperative or autopsy findings (gross enteric spillage, anastomotic disruption), expressed in percentage. [time frame: from 1st to 30th postoperative day]. And identify the main associated factors through a multivariate model regression. | from 1st to 30th postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| overall morbidity | The rate of overall morbidity in patients with and without AL. Refers to adverse events and complications following surgery and classified by Clavien Dindo score | from 1st to 60 postoperative day |
| operative mortality |
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Inclusion Criteria:
Exclusion Criteria:
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Patients from all participating centers older than 18 years, males or females, with the diagnosis of primary right colon cancer including the cecum, ascendent, liver flexure, and proximal third of the transverse colon, in both emergency and elective settings, with the indication of RH, referred as to the resection of a portion of the distal ileum, cecum, ascending colon, and proximal to the mid-transverse colon, with intraperitoneal or extraperitoneal primary handsewn or mechanical ileocolic anastomosis by minimally invasive(robotic or laparoscopic) or open approach.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rossella Reddavid, MD, PhD | Contact | +300119026224 | rossella.reddavid@unito.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Luigi Gonzaga | Recruiting | Orbassano | Piedmont | 10043 | Italy |
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The rate of operative mortality in patients with and without AL. Operative mortality was defined as death that occurred within 30 days after the primary operation
| within 30 postoperative days |
| Length of stay. | Total Length of stay. Defined as the length of an inpatient episode of care, calculated from the surgery day to the day of discharge and based on the number of nights spent in the hospital. Adding all the admissions episodes related and no related to AL | from date of surgery up to 200 days |
| reoperation | The rate of reoperation in patients with and without AL: defined of the total cases of patients submitted to secondary surgery for any direct untoward effect of the right colon resection | from 1st to 60 postoperative day |