DEBUT: Diverticulitis Evaluation of Patient Burden, Utilization, and Trajectory

NCT02776787 | Completed

• 2 other identifiers: STUDY000037081R01DK103915-01A1
• Study Type: observational
• Target: 418
• Locations: 1 country
• Sites: 9

Brief Summary

Half of all Americans over 60 years of age have diverticulitis of the colon. Over the last decade, the use of elective colon resection has increased by more than 50%, and diverticulitis is now the leading reason for elective colectomy. Surgeons and patients alike have a difficult time deciding if surgery is the best choice to treat diverticulitis. The goal of the DEBUT study is to improve the understanding about how doctors and patients make decisions to have elective surgery for diverticulitis, and the global impact of diverticulitis on patients' lives.

Conditions

Diverticulitis

Outcome Measures

Primary Outcomes (1)

• Patient-reported symptom burden and quality of life measured by the Diverticulitis Quality of Life scale (DV-QOL)

  Patient-reported burden of disease (diverticulitis symptoms and quality of life, as measured by the Diverticulitis Quality of Life scale (DV-QOL)) will be measured over time among patients that do and do not undergo elective colon resection.

  3 months - 4 years

Secondary Outcomes (1)

• Number of patients who report non-clinical factors as reason for deciding to have surgery

  3 months - 4 years

Study Arms (2)

Patients

Patients with diverticulitis

Surgeons

Surgeons who perform elective colon resections

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 confirmed diagnoses of diverticulitis will be recruited from emergency rooms (first time episodes), GI clinics, and surgical clinics across the Pacific Northwest and California.

You may qualify if:

• Patients with confirmed diagnosis of diverticulitis
• Patients 18 years of age or older
• Patients who are able to consent to participate in research

You may not qualify if:

• Patients that have had prior colon resection surgery
• Patients that do not make their own medical decisions

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (9)

UCLA Ronald Reagan

Los Angeles, California, 90095, United States

Location

Olive View - UCLA Medical Center

Sylmar, California, 91342, United States

Location

NYU Langone Health

Brooklyn, New York, 11220, United States

Location

Legacy Health

Portland, Oregon, 97210, United States

Location

Skagit Regional Health

Mount Vernon, Washington, 98274, United States

Location

Valley Medical Center

Renton, Washington, 98055, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Northwest Hospital and Medical Center

Seattle, Washington, 98133, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Diverticulitis

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Giana Davidson, MD, MPH

  University of Washington

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Surgical Outcomes Research Center

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 18, 2016
• Study Start: March 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: April 1, 2022
• Last Updated: December 5, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)