Surgical and Oncological Outcomes in Patients With Ulcerative Colitis-associated Rectal Cancer

NCT04659148 | Unknown

• 1 other identifier: 2712-2020
• Study Type: observational
• Target: 40
• Locations: 2 countries
• Sites: 2

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.

Conditions

Ulcerative Colitis; Rectal Cancer

Keywords

Ulcerative Colitis; Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• Surgical outcome

  30 days postoperative complications

  30 days after surgery

• Oncological outcome

  Disease-free survival

  5 years after surgery

Interventions

Total proctocolectomy PROCEDURE

Total proctocolectomy: surgical removal of the colon, rectum, and anus

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

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.

You may qualify if:

• 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.

You may not qualify if:

• Patients aged\<18 years;
• Patients with a diagnosis of undetermined colitis;
• Insufficient follow-up data.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (2)

Humanitas Research Hospital

Rozzano, MI, 20089, Italy

RECRUITING

St. Mark's Hospital

Harrow, HA1 3UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Rectal Neoplasms

Interventions

Proctocolectomy, Restorative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Antonino Spinelli, MD, PhD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Maroli

CONTACT

+390282247776; annalisa.maroli@humanitas.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: October 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: April 1, 2021
• Last Updated: December 9, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); GB (1)