Colorectal Cancer in Crohn's Disease

• Conditions: Colorectal Cancer; Inflammatory Bowel Diseases; Crohn Disease
• Interventions: Procedure: Total proctocolectomy; Procedure: Total colectomy; Procedure: Segmental colectomy

• Registration Number: NCT04654494
• Lead Sponsor: University of Rome Tor Vergata

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-11-29
• Study First Submitted QC: 2020-11-29
• Status Verified: 2020-12
• Study First Posted: 2020-12-04
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-08
• Primary Completion: 2021-01
• Study Completion: 2021-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chron's disease patients with colorectal cancer	Total proctocolectomy	This group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically
Chron's disease patients with colorectal cancer	Total colectomy	This group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically
Chron's disease patients with colorectal cancer	Segmental colectomy	This group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically

Primary Outcome Measures

Name	Time	Method
Overall Survival	5 years	percentage of patients alive
disease free survival	5 years	percentage of patients disease free

Trial Locations

Locations (1)

Policlinico Tor Vergata; 🇮🇹 Roma, RM, Italy