Colorectal Cancer in Crohn's Disease

NCT04654494 | Unknown

• 1 other identifier: REGISTROSPERIMENTAZIONI120/20
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Crohn Disease; Colorectal Cancer; Inflammatory Bowel Diseases

Keywords

colorectal surgery

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  percentage of patients alive

  5 years

• disease free survival

  percentage of patients disease free

  5 years

Study Arms (1)

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; Procedure: Total colectomy; Procedure: Segmental colectomy

Interventions

Total proctocolectomy PROCEDURE

excision of the whole large bowel including colon and rectum and end ileostomy fashioning

Chron's disease patients with colorectal cancer

Total colectomy PROCEDURE

excision of the colon with preservation of the rectum

Chron's disease patients with colorectal cancer

Segmental colectomy PROCEDURE

excision of a segment of colon

Chron's disease patients with colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Policlinico Tor Vergata

Roma, RM, 00133, Italy

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colorectal Neoplasms; Inflammatory Bowel Diseases

Interventions

Proctocolectomy, Restorative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Colectomy; Surgical Procedures, Colorectal; Digestive System Surgical Procedures; Surgical Procedures, Operative; Proctectomy

Central Study Contacts

Bruno Sensi, MD

CONTACT

3385352902; brunosensi@outlook.it

Giuseppe S Sica, MD, PhD

CONTACT

3385333659; sigisica@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Head of Department

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 4, 2020
• Study Start: July 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)