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

Ulcerative Colitis Clinical Trial

— UC-RectalK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04659148
• Other study ID #: 2712-2020
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: December 2020
• Source: Istituto Clinico Humanitas
• Contact: Annalisa Maroli
• Phone: +390282247776
• Email: annalisa.maroli[@]humanitas.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 1, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Rectal Cancer
• Rectal Neoplasms
• Ulcer
• Ulcerative Colitis

Intervention

Procedure:
• Total proctocolectomy
Total proctocolectomy: surgical removal of the colon, rectum, and anus

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano	MI
United Kingdom	St. Mark's Hospital	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical outcome	30 days postoperative complications	30 days after surgery
Primary	Oncological outcome	Disease-free survival	5 years after surgery