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

Diverticulitis Clinical Trial

— DEBUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776787
• Other study ID #: STUDY00003708
• Secondary ID: 1R01DK103915-01A
• Status: Completed
• Start date: March 2016
• Est. completion date: April 2022

Study information

• Verified date: December 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This study will examine both clinical and non-clinical reasons for pursuing surgery, taking into account previously unexplored areas in surgical decision-making including the comprehensive impact of this disease, as well as factors that impact a surgeon's willingness to recommend surgery. Ultimately, this patient-centered research approach will help us understand the impact of treatment decisions on a patient's quality of life, work, and clinical symptoms, and will ultimately help to inform our recommendations for the treatment of patients with diverticulitis.

The DEBUT study was developed from questions raised by our Washington State Surgical Collaborative, (SCOAP Colon and Rectal Surgery Work Group) and will be carried out in clinics and hospitals across Washington State, Oregon, and California. The investigators invite patients to participate in research activities designed to identify the impact of diverticulitis and treatment options, in order to better understand the outcomes that matter most to patients. Patients who are considering surgery or who have received treatment for their diverticulitis will be recruited for study participation. Participants will complete a baseline survey via a convenient electronic platform, and follow-up surveys will be sent quarterly for up to four years. These surveys will examine quality of life, overall health, and clinical symptoms to understand what drives patients and surgeons to an operation, as well as how that decision impacts quality of life and recurrent events in patients that choose to have surgery compared to those that do not have surgery. Participating surgeons will complete surveys that examine their indications for surgery and surgical outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: April 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with confirmed diagnosis of diverticulitis

• Patients 18 years of age or older

• Patients who are able to consent to participate in research

Exclusion Criteria:

• Patients that have had prior colon resection surgery

• Patients that do not make their own medical decisions

Related Conditions & MeSH terms

• Diverticulitis

Locations

Country	Name	City	State
United States	NYU Langone Health	Brooklyn	New York
United States	UCLA Ronald Reagan	Los Angeles	California
United States	Skagit Regional Health	Mount Vernon	Washington
United States	Legacy Health	Portland	Oregon
United States	Valley Medical Center	Renton	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Northwest Hospital and Medical Center	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Olive View - UCLA Medical Center	Sylmar	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients who report non-clinical factors as reason for deciding to have surgery	Patient-reported factors (clinical and non-clinical) for deciding to have elective colon surgery, or deciding to have medical management for diverticulitis will be analyzed across surgical and non-surgical patients.	3 months - 4 years

External Links

•   Related Info