Assessing anastomotic leakage after right hemicolectomy for cancer
"Anastomotic Leakage After Right Hemicolectomy for Cancer, a Prospective Multicenter Study of SICO-CC Network." (AL RIGHT).
This study is trying to find out how often patients with right colon cancer experience leaks after surgery and what factors might increase that risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1839 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | San Luigi Gonzaga Hospital Academic / other |
| Locations | 1 site (Orbassano, Piedmont) |
| Trial ID | NCT06688383 on ClinicalTrials.gov |
What this trial studies
This nationwide observational study aims to evaluate the rate of anastomotic leakage following right hemicolectomy in patients with right colon cancer. It will identify independent risk factors associated with anastomotic leakage and develop a clinical prediction model to estimate the likelihood of this complication post-surgery. The study involves multiple high-volume colorectal surgery centers across Italy, coordinated by the University of Turin's Division of Surgical Oncology and Digestive Surgery. Ethical approvals will be sought from relevant committees before the study's implementation.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a diagnosis of primary right colon cancer requiring surgical resection.
Not a fit: Patients with benign conditions, inflammatory bowel disease, or those on long-term steroid treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing right hemicolectomy for cancer.
How similar studies have performed: Other studies have explored anastomotic leakage in colorectal surgery, indicating that this approach is built on existing knowledge but aims to refine risk assessment and prediction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * -Long steroid treatment for any cause. * Right colon resection for benign disease. * History of supra-mesocolic space radiotherapy. * Inflammatory bowel disease (Crohn's disease and ulcerative colitis). No healthy volunteers are accepted.
Where this trial is running
Orbassano, Piedmont
- San Luigi Gonzaga — Orbassano, Piedmont, Italy (Recruiting)
Study contacts
- Study coordinator: Rossella Reddavid, MD, PhD
- Email: rossella.reddavid@unito.it
- Phone: +300119026224
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.