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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-04-01

Brief Summary

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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

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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.

Conditions

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Ulcerative Colitis Rectal Cancer

Keywords

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Ulcerative Colitis Rectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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Total proctocolectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonino Spinelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

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Humanitas Research Hospital

Rozzano, MI, Italy

Site Status RECRUITING

St. Mark's Hospital

Harrow, , United Kingdom

Site Status RECRUITING

Countries

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Italy United Kingdom

Central Contacts

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Annalisa Maroli

Role: CONTACT

Phone: +390282247776

Email: [email protected]

Facility Contacts

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Humanitas R Hospital

Role: primary

Role: backup

Vittoria Bellato, MD