Surgical and Oncological Outcomes in Patients With Ulcerative Colitis-associated Rectal Cancer (UC-RectalK)

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

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.

Study Overview

• Status: Unknown
• Conditions: Rectal Cancer; Ulcerative Colitis
• Intervention / Treatment: Procedure: Total proctocolectomy

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Recruiting
      • Humanitas Research Hospital
      • Sub-Investigator: Michele Carvello, MD
• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • Recruiting
    • St. Mark's Hospital
    • Contact: Vittoria Bellato, MD; Phone Number: +44 (0)20 8864 3232; Email: vittoria.bellato@gmail.com
    • Principal Investigator: Janindra Warusavitarne, MD, PhD
    • Sub-Investigator: Vittoria Bellato, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical outcome	30 days postoperative complications	30 days after surgery
Oncological outcome	Disease-free survival	5 years after surgery

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): January 30, 2021
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (ACTUAL): December 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Rectal Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Inflammatory Bowel Diseases; Ulcer; Rectal Neoplasms; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 2712-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No