Actively Recruiting
Anastomotic Leakage After Right Hemicolectomy for Cancer, a Prospective Multicenter Study of SICO-CC Network
Led by San Luigi Gonzaga Hospital · Updated on 2024-11-14
1839
Participants Needed
1
Research Sites
282 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: * Preoperative: baseline, disease and demographics. * Operative: details about the surgery, anastomosis construction and enterotomy closure. * Follow-up: outcomes data about the early (within 30 postoperative day) and late postoperative course (31 th - 60th postoperative day) and pathology report. The definition of AL is based on the presence of clinical signs (pain, fever, tachycardia, peritonitis, feculent or enteric drainage, purulent drainage, postoperative ileus, abscess, septicemia, and/or organ failure) with radiographic signs (fluid collections, gas containing collections at CT scan) suggestive of AL and-or intraoperative or autopsy findings (gross enteric spillage, anastomotic disruption). The absence of AL will be assumed by a normal postoperative course and the absence of symptoms suggestive of AL with or without radiologic confirmation.
CONDITIONS
Official Title
Anastomotic Leakage After Right Hemicolectomy for Cancer, a Prospective Multicenter Study of SICO-CC Network
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years old
- Diagnosis of primary right colon cancer including cecum, ascending colon, liver flexure, and proximal third of transverse colon
- Scheduled for right hemicolectomy involving resection of distal ileum, cecum, ascending colon, and proximal to mid-transverse colon
- Surgery performed with handsewn or mechanical ileocolic anastomosis by minimally invasive (robotic or laparoscopic) or open approach
- Patients in both emergency and elective surgery settings
You will not qualify if you...
- Long-term steroid treatment for any cause
- Right colon resection for benign disease
- History of radiotherapy to supra-mesocolic space
- Inflammatory bowel disease such as Crohn's disease or ulcerative colitis
- Healthy volunteers not accepted
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
San Luigi Gonzaga
Orbassano, Piedmont, Italy, 10043
Actively Recruiting
Research Team
R
Rossella Reddavid, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here