Colorectal Cancer in Crohn's Disease

Colorectal Cancer in Crohn's Disease: Long Term Outcomes of Different Surgical Procedures

Retrospective multicentre study. All patients with a diagnosis of Crohn's disease (CD) and operated for colorectal cancer (CRC) between 01/01/2010 and 01/01/2020 will be included in the dataset.

Data will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible.

The study will focus on a comparison between patients treated with total proctocolectomy (TPC) and patients treated with subtotal colectomy (STC) or segmental resection (SR).

Primary endpoints will be oncologic outcomes, postoperative morbidity and mortality. Secondary endpoints include quality of life (QoL).

Study Overview

• Status: Unknown
• Conditions: Inflammatory Bowel Diseases; Colorectal Cancer; Crohn Disease
• Intervention / Treatment: Procedure: Total proctocolectomy; Procedure: Total colectomy; Procedure: Segmental colectomy

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00133
      • Recruiting
      • Policlinico Tor Vergata

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

Patients with Crohn's disease complicated by occurrence of colorectal cancer, treated surgically between 01/2010 and 01/2020

Description

Inclusion Criteria:

• All patients with a diagnosis of Crohn's disease and concomitant primary colorectal cancer who underwent surgery in an expert centre between 01/01/2010 and 01/01/2020

Exclusion Criteria:

• Patients who underwent non-oncologic segmental resection will be excluded from outcome analysis.
• Patients with known genetic colorectal cancer syndromes (eg. Familial Adenomatous Polyposis, Hereditary Non-Polyposis ColoRectal Cancer Syndrome)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chron's disease patients with colorectal cancer; This group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically	Procedure: Total proctocolectomy; excision of the whole large bowel including colon and rectum and end ileostomy fashioning; Procedure: Total colectomy; excision of the colon with preservation of the rectum; Procedure: Segmental colectomy; excision of a segment of colon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	percentage of patients alive	5 years
disease free survival	percentage of patients disease free	5 years

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2021
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: November 29, 2020
• First Posted (ACTUAL): December 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: colorectal surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; 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; Crohn Disease
• Other Study ID Numbers: REGISTROSPERIMENTAZIONI120/20

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