Surgical and Oncological Outcomes in Patients With Ulcerative Colitis-associated Rectal Cancer
NCT ID: NCT04659148
Last Updated: 2020-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2020-10-01
2021-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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Total proctocolectomy
Total proctocolectomy: surgical removal of the colon, rectum, and anus
Eligibility Criteria
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Inclusion Criteria
* Patients diagnosed with rectal cancer (within 15 cm from the anal verge);
* Patients who underwent surgery for rectal cancer between January 2004 and January 2020;
* All type of surgery will be included;
* Surgery in elective and emergency settings.
Exclusion Criteria
* Patients with a diagnosis of undetermined colitis;
* Insufficient follow-up data.
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Principal Investigators
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Antonino Spinelli, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Istituto Clinico Humanitas
Locations
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Humanitas Research Hospital
Rozzano, MI, Italy
St. Mark's Hospital
Harrow, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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2712-2020
Identifier Type: -
Identifier Source: org_study_id
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