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

• Conditions: Ulcerative Colitis; Rectal Cancer

• Registration Number: NCT04659148
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2020-10-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Last Update Submitted: 2020-12-02
• Study First Posted: 2020-12-09
• Last Update Posted: 2020-12-09
• Primary Completion: 2021-01-30
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oncological outcome	5 years after surgery	Disease-free survival
Surgical outcome	30 days after surgery	30 days postoperative complications

Trial Locations

Locations (2)

Humanitas Research Hospital; 🇮🇹 Rozzano, MI, Italy

St. Mark's Hospital; 🇬🇧 Harrow, United Kingdom