Colorectal Cancer in Crohn's Disease

NCT ID: NCT04654494

Last Updated: 2020-12-08

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

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-01-31

Brief Summary

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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

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Conditions

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Crohn Disease Colorectal Cancer Inflammatory Bowel Diseases

Keywords

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colorectal surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chron's disease patients with colorectal cancer

This group of patients with Chron's disease have been diagnosed with colorectal cancer and treated surgically

Total proctocolectomy

Intervention Type PROCEDURE

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

Total colectomy

Intervention Type PROCEDURE

excision of the colon with preservation of the rectum

Segmental colectomy

Intervention Type PROCEDURE

excision of a segment of colon

Interventions

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Total proctocolectomy

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

Intervention Type PROCEDURE

Total colectomy

excision of the colon with preservation of the rectum

Intervention Type PROCEDURE

Segmental colectomy

excision of a segment of colon

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Sigismondo Sica

Associate Professor, Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico Tor Vergata

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Bruno Sensi, MD

Role: CONTACT

Phone: 3385352902

Email: [email protected]

Giuseppe S Sica, MD, PhD

Role: CONTACT

Phone: 3385333659

Email: [email protected]

Facility Contacts

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Bruno Sensi, MD

Role: primary

Giuseppe S Sica, MD, PhD

Role: backup

Other Identifiers

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REGISTROSPERIMENTAZIONI120/20

Identifier Type: -

Identifier Source: org_study_id