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Clinical Trials/NCT04659148
NCT04659148
Unknown
Not Applicable

Surgical and Oncological Outcomes in Patients With Ulcerative Colitis Associated Rectal Cancer: a Retrospective Study

Istituto Clinico Humanitas2 sites in 2 countries40 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ulcerative Colitis
Sponsor
Istituto Clinico Humanitas
Enrollment
40
Locations
2
Primary Endpoint
Oncological outcome
Last Updated
5 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
April 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istituto Clinico Humanitas
Responsible Party
Sponsor

Eligibility Criteria

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 Criteria

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

Outcomes

Primary Outcomes

Oncological outcome

Time Frame: 5 years after surgery

Disease-free survival

Surgical outcome

Time Frame: 30 days after surgery

30 days postoperative complications

Study Sites (2)

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