An observational study in Ulcerative Colitis and Rectal Cancer, sponsored by Istituto Clinico Humanitas. Status unknown at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-09.
Sponsored by Istituto Clinico Humanitas · Observational
This is a retrospective observational study to investigate the short-term surgical outcomes, and long-term oncological outcomes of patients diagnosed with Ulcerative colitis and rectal cancer.
Inflammatory Bowel Disease (IBD) is a risk factor for the development of colorectal cancer (CRC). Despite improved targeted screening and timely prophylactic resection, up to 15% of all IBD-related mortality can be attributed to CRC.
Previous reports suggest that IBD patients present with CRC at an earlier age and with more advanced disease than those with sporadic CRC. The literature is limited, however, with respect to colitis-associated rectal cancer (CARC), which has unique considerations such as surgical approach and the use of neoadjuvant therapy. Although total proctocolectomy is generally the procedure of choice for those with CARC, recent reports reported acceptable oncological outcomes after ileal pouch-anal anastomosis (IPAA) and ileorectal anastomosis (IRA).
The impact of the type of surgical procedure on the oncologic outcome in patients with CARC is not well defined.
The aim of this study is to investigate short-term surgical outcomes (postoperative complications at 30 days after surgery) and long-term oncological outcomes (disease-free survival) of CARC patients undergoing different surgical approaches.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 40 is below the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will include adult patients with a proven diagnosis of Ulcerative Colitis and rectal adenocarcinoma, who underwent intestinal resection for curative intent, in elective or emergent setting, in the period between January 2004 and January 2020.
Exclusion Criteria:
Total proctocolectomy: surgical removal of the colon, rectum, and anus
Surgical outcome
30 days postoperative complications
Time frame: 30 days after surgery
Oncological outcome
Disease-free survival
Time frame: 5 years after surgery
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Istituto Clinico Humanitas