Surgical and Oncological Outcomes in Patients With Ulcerative Colitis-associated Rectal Cancer

Last updated: December 2, 2020
Sponsor: Istituto Clinico Humanitas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rectal Cancer

Ulcerative Colitis

Inflammatory Bowel Disease

Treatment

N/A

Clinical Study ID

NCT04659148
2712-2020
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with Ulcerative Colitis;
  • 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

Exclusion Criteria:

  • Patients aged<18 years;
  • Patients with a diagnosis of undetermined colitis;
  • Insufficient follow-up data.

Study Design

Total Participants: 40
Study Start date:
October 01, 2020
Estimated Completion Date:
April 01, 2021

Study Description

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.

Connect with a study center

  • Humanitas Research Hospital

    Rozzano, MI 20089
    Italy

    Active - Recruiting

  • St. Mark's Hospital

    Harrow, HA1 3UJ
    United Kingdom

    Active - Recruiting

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