Clinical trial NCT04659148: Surgical and Oncological Outcomes in Patients With Ulcerative Colitis-associated Rectal Cancer
Official title: Surgical and Oncological Outcomes in Patients With Ulcerative Colitis Associated Rectal Cancer: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Rectal Cancer
Keywords: Ulcerative Colitis
Rectal Cancer
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Surgical outcome
timeFrame: 30 days after surgery
measure: Oncological outcome
timeFrame: 5 years after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: MI
city: Harrow
country: United Kingdom
facility: St. Mark's Hospital
Study officials:
affiliation: Istituto Clinico Humanitas
name: Antonino Spinelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: